Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: datex-ohmeda engstrom carestation
health canada posted a medical device safety alert concerning engstrom carestation manufactured by datex-ohmeda inc. the affected model is 1505-9000-000 and the affected lot numbers are cbcp01415, cbcp01452 and cbcp01475.
specific combinations of engstrom ventilator casters and bases have been identified that pose an increased likelihood of failures of the caster mounting hardware. a failure of the caster mounting hardware may result in the ventilator falling/tipping (overbalancing) which can result in serious injury to patients or staff.
for details, please refer to the following link:
http://healthycanadians.Gc.Ca/recall-alert-rappel-avis/hc-sc/2015/43635r-eng.Php
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 9 february 2015.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Press release
Causa
Voluntary recall of device containing non-sterile radioactive material
the department of health (dh) received notification from a medical
device manufacturing company about its voluntary recall of a batch
of radiodiagnostic device which has failed the sterility test.
according to the company- uk ge healthcare, the involved batch
was known as drytec tc-99m generator lot number 5666. there was
a possibility of infection if the non-sterile product was injected
into patients.
the device is used to prepare radioactive material for injection
to patients during radiodiagnostic procedures.
information available showed that the affected lot had been used
in tuen mun hospital and hong kong sanatorium and hospital. so far,
no adverse effect associated with the use of device has been received
by dh.
the dh has informed the hospital authority, private hospitals,
radiodiagnostic laboratories and medical professional associations
about the recall and advised them to check for details with the
company.
dh will continue to monitor the situation and advise the public
and health profession accordingly.
ends/wednesday, april 23, 2008.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Fda class i recall: ge healthcare vital signs hygroscopic condenser humidifier passive humidification device (hch) for vital signs anesthesia breathing circuits
it has come to our attention that the u.S. food and drug administration (fda) has issued a class i recall concerning ge healthcare vital signs hygroscopic condenser humidifier passive humidification device (hch) for vital signs anesthesia breathing circuits.
the vital signs hch is sold as part of the vital signs anesthesia breathing circuit. an hch is used to maintain moisture in the patient's airway during mechanical ventilation. the affected device may have an occlusion that can prevent proper flow of the medical gases or oxygen, possibly resulting in insufficient oxygen delivered to the patient.
clinical users have been directed to not use the anesthesia circuits containing the vital signs devices passive humidification device (hygroscopic condenser humidifier, or "hch"), or the stand alone hch device with the affected product item numbers and lot numbers, and to isolate all affected product.
according to the local supplier, hong kong is not affected.
for details, please visit the following fda website:
http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm266542.Htm
if you are in possession of the affected product, please contact your supplier for necessary actions.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: ge aestiva/5 7900 smartvent
the united states food and drug administrations (fda) has issued a class i recall concerning aestiva/5 7900 smartvent (serial number amrp01031 amrp00966 amrp01030 amrp00968 amrp00967 amrp01033 amrp00970 amrp00969), manufactured by ge healthcare, llc.
the manufacturer has recently become aware of a potential safety issue due to the interlock slide mechanism missing from the 3-vaporizer manifold of the aestiva 7900 anesthesia device. there is a potential for two vaporizers delivering agent at the same time. this could manifest as over delivery of a single agent if both vaporizers contain the same agent or as delivery of more than one agent. this may cause prolonged or persistent hypotension requiring medical intervention. to date, no injury has been reported to ge healthcare associated with this issue.
according to the local supplier, the affected products were not distributed in hong kong.
for details, please refer to fda websites
http://www.Accessdata.Fda.Gov/scripts/enforcement/enforce_rpt-event-
detail.Cfm?action=detail&id=61639&w=06272012
if you are in possession of the affected product, please contact your supplier for necessary actions.
posted on 28 june 2012.
Czech data is current through July 2018. All of the data comes from the Czech Public Registry of Medical Devices, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and the Czech Republic.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: ge healthcare nuclear medicine systems
it has come to our attention that medical device manufacturer, ge healthcare has initiated a field safety corrective action concerning its nuclear medicine systems. the affected products are 1) infinia nuclear medicine systems; 2) vg and vg hawkeye nuclear medicine systems; 3) helix nuclear medicine systems; 4) brivo nm615; 5) discovery nm630; 6) optima nm/ct640; and 7) discovery nm/ct 670.
on 5 june 2013, ge healthcare became aware of an incident in the united states that a patient died due to injuries sustained while being scanned on an infinia hawkeye 4 due to a portion of the system falling onto the patient during the scan. investigation by the manufacturer found that bolts securing the camera to the gantry were loose, thereby stressing the support mechanism and resulting in the incident.
because of the similarities in the design of support mechanisms across many products, the manufacturer has included all types and manufacturing dates of infinia and infinia hawkeye nuclear medicine systems; all types and manufacturing dates of vg and vg hawkeye nuclear medicine systems; and all types and manufacturing dates of helix nuclear medicine systems by elscint ltd. the manufacturer stated that the issue should also affected brivo nm615, discovery nm630, optima nm/ct640, discovery nm/ct670 due to similarities in basic mechanical concepts between these devices and the infinia systems.
ge healthcare will inspect all affected systems to verify that the support mechanism fasteners are secured properly. furthermore, ge healthcare recommends that users to cease use of their nuclear medicine system until ge healthcare can complete an inspection of their system.
according to the local supplier, the affected products are distributed in hong kong.
if you are in possession of the product, please contact your supplier for necessary actions.
posted on 05 july 2013.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: ge healthcare tec 6 and tec 6 plus vaporizers
medical device manufacturer, ge healthcare issued a medical device safety alert concerning all tec 6 and tec 6 plus vaporizers.
according to the ge healthcare, the user manual pre-operative check, low pressure leak test at 1% dial setting may not detect the full range of leaks from seal wear degradation in the vaporizers. moreover, the integrity of the vaporizer seal may be affected with tec 6 or tec 6 plus vaporizer remanufactured/ manufactured between 12 aug 2005 and 3 dec 2012, due to wear degradation.
for any tec 6 or tec 6 plus vaporizer remanufactured / manufactured between 12 aug 2005 and 3 dec 2012 (aetj29001 to aesr49001), a ge healthcare service representative will schedule a repair to update the vaporizer seal. the leak test failures will get first priority for scheduling repair/replacement
the manufacturer advises that the addendum with the field safety notice distributed to the affected users had the 12% low pressure leak test which will aid in determining the integrity of the seal. the manufacturer also provides the following recommendations to the affected users:
update the tec 6 and tec 6 plus vaporizers user manual with the addendum given.
perform the user manual recommended pre-operative check which includes the low pressure leak test on every vaporizer with the dial turned to the 12% setting instead of the specified 1% setting.
discontinue use of the tec 6 or tec 6 plus vaporizer if it does not pass the new low pressure leak at 12%, remove it from service and contact a ge healthcare representative for a repair/replacement.
if the vaporizer passes the new low pressure leak test at the 12 % setting, it can be used, however, as detailed in the user manual, users should continue to routinely perform the pre-operative check which includes the low pressure leak test.
use a monitor to measure the oxygen and anesthetic agent levels as well as monitoring the bellows position during the use of any anesthesia system.
according to the local supplier, the affected products have been distributed to hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 13 august 2013.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: ge healthcare resuscitation systems
the australia therapeutic goods administration (tga) posted a medical device safety alert concerning the following products manufactured by ge healthcare:
giraffe stand alone resuscitation systems with blender;
giraffe warmer integrated resuscitation systems with blender;
panda warmer integrated resuscitation systems with blender;
panda freestanding warmer integrated resuscitation systems with blender; and
resuscitation system field upgrade kits with blender.
the manufacturer has recently become aware of a potential safety issue associated with the loosening of the blender knob shaft on all resuscitation units. a loose blender knob shaft may potentially affect the accuracy of the blended output of air/ oxygen gas mixture from the unit which could result in hypoxia or hyperoxia.
the manufacturer advises users to perform a blender accuracy check as outlined in the service manual to verify the oxygen concentration set at 21% and 100% settings are within the recommended range.
if the blender accuracy test results do not meet specification, users are advised to remove the system from patient use and contact the manufacturer. if the blender accuracy results pass, the system is suitable for continued use. however, the manufacturer recommends that a pulse oximeter should be used to monitor the patient when delivering oxygen.
the manufacturer will correct all affected systems as a permanent fix.
for details, please visit the following tga website:http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2013-rn-01334-1
if you are in possession of the affected product, please contact your supplier for necessary actions.
posted on 20 december 2013.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Health canada type ii recall: warmair model 134
it has come to our attention that the health canada has issued a type ii recall on the cincinnati sub-zero products warmair model 134.
the warmair 134 is used in conjunction with a single-patient use blanket to warm a patient's body temperature. one of the connectors attached to the warmair 134 device's printed circuit board can overheat. this may result in damage to the device's external case and/or melting of some of the internal components.
for details, please refer to the following link:
http://www.Hc-sc.Gc.Ca/dhp-mps/compli-conform/
recall-retrait/_list/rec-ret_md-im_date_oct-dec_2011-eng.Php
if you are in possession of the product, please contact your supplier or manufacturer for necessary actions or recommendations.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: arjohuntleigh encore, chorus and sara plus standing aids
the medicines and healthcare products regulatory agency (mhra), united kingdom issued a medical device alert concerning encore, chorus and sara plus standing aids manufactured by arjohuntleigh.
arjohuntleigh has recently been made aware of an unfortunate serious accident. during exercise, an encore standing and raising aid was used to support the patient to stand. the knee pad had been removed. however the support bracket holding the proactive knee pad support had not been removed as described in the instructions for use manual. this results in a vertical square section end of the metal support bracket becoming exposed. it would appear that the patient fell onto the metal bracket causing severe trauma.
the manufacturer supplemented that this accident could have been avoided if the support bracket assembly had been removed with the proactive knee pad support. therefore, arjohuntleigh reminded users that the entire knee and support bracket assembly must be removed when required to do so for exercise. the manufacturer has amended the instructions for use to highlight the need to remove the bracket completely.
according to the local supplier, the affected products have been distributed in hong kong.
for details, please refer to the following mhra website:
http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/medicaldevicealerts/
index.Htm
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 12 july 2012.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: arjohuntleigh alenti lift and hygiene chair
health canada has issued a medical device safety alert, concerning alenti lift and hygiene chair., manufactured by arjohuntleigh.
arjohuntleigh, in collaboration with health canada, issued the safety notice to re-iterate safety information to prevent the risk of chair tipping and patient falls with the alenti lift and hygiene chair. these incidents can be caused by operator use error and patient factors, and can lead to serious patient injury or death.
between 2004 and 2007, arjohuntleigh conducted field safety correction actions to provide improved safety instructions and warnings to reduce the risk of alenti chair tipping and patient falls. the incident rate has since declined; however, arjohuntleigh continues to receive several incident reports in canada each year. to further reduce the number of incidents associated with the alenti chair, arjohuntleigh would like to re-iterate the following important safety information.
alenti chair tipping and patient falls can occur if an operator fails to strictly follow all operating and safety instructions in the instructions for use.
alenti chair tipping and patient falls have continued to occur in canada, some of them leading to serious patient injuries and death.
all personnel who may be involved in operating the alenti chair should be familiar with the risk factors that are known to cause chair tipping and patient falling incidents.
for details, please visit the following health canada website:
http://healthycanadians.Gc.Ca/recall-alert-rappel-avis/hc-sc/2013/
29019a-eng.Php
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 08 may 2013.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: arjohuntleigh contoura 450 and project versions of 25000e/l hospital bed frames
the medicines and healthcare products regulatory agency (mhra), united kingdom (uk) posted a medical device safety alert concerning contoura 450 and project versions of 25000e/l hospital bed frames manufactured by arjohuntleigh. model numbers c450l, 25000e/lpd73, 25000e/lpd77, 25000e/lpd75, 25000e/lpd76, 25000e/lpd90 and 25000e/lpe12 are affected.
spare backrest actuators (part number s6686, linak ref. 321021) for the bed frames indicated above are supplied with a pre-wired safety limit switch (sls) that operates as the actuator extends and prevents the backrest being driven to angles greater than 60o above the horizontal.
according to the manufacturer, approximately 200 of these actuators sold as spare parts were supplied with the sls incorrectly connected. on beds fitted with these parts, if the backrest is driven to an angle of 60o, the sls does not operate as intended and the backrest continues to rise until the actuator reaches its limit of travel. once in this position, it may not be possible to lower the backrest, either electrically or by using the manual cardiopulmonary resuscitation (cpr) release. it is potentially life-threatening if the backrest cannot be lowered when a patient requires cpr or other emergency treatment.
arjohuntleigh advises the users to test all suspect actuators according to the instructions given in the field safety notice. faulty actuators should be returned to arjohuntleigh for modification or disposal.
according to the local supplier, the affected products were not distributed in hong kong.
for details, please visit the following mhra website:
http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con336744
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 26 november 2013.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: arjohuntleigh quick connect scales used with maxi sky 2 ceiling lifts
medical device manufacturer, arjohuntleigh, has issued a medical device safety alert concerning its quick connect scales used with maxi sky 2 ceiling lifts the affected products are as follows: -
product codes: a) 700-19485; b) 700-19490
serial numbers: a) from 300146551 up to 300220716; b) from 300142013 up to 300219867
manufactured between june 2016 and november 2017.
the manufacturer has received a limited number of complaints where it was mentioned there was a disconnection occurrence of the spreader bar from the quick connect scale.
according to the manufacturer, the hazard could be replicated under a specific sequence of events. if a spreader bar detaches from the quick connect attachment of the scale, a patient can fall and may lead to a potential risk of injury.
the manufacturer shall arrange local service technician to visit the facilities to carry out the upgrade of the scales. the affected customers are requested to ensure that all caregivers and users of the affected devices are made aware of the field safety notice and all listed devices at their facility are available to be corrected during service technician visit.
the device may stay in use until the upgrade will be performed, on the condition that the following instructions are carefully followed:
before initiating the patient transfer, once the patient is installed in the sling and the weight is gradually taken up, always check that the scale quick connect lower attachment is aligned with the spreader bar quick connect.
if not, do not proceed with the patient transfer, lower the patient, remove completely the patient weight on the scale and then reinstall adequately the spreader bar attachment.
according to the local supplier, the affected products are distributed in hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 23 february 2018.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: maquet cardiovascular llc flow-i anaesthesia system
the united states food and drug administration (fda) has issued a medical device safety alert concerning flow-i anaesthesia system, manufactured by maquet cardiovascular llc.
in some flow-i anesthesia systems, patient cassette can get dislodged which could result in gas leakage within the system internal circuit potentially leading to a stop in ventilation.
for details, please refer to the fda websites:
http://www.Accessdata.Fda.Gov/scripts/enforcement/enforce_rpt-product-tabs.Cfm?action=select&recall_number=z-1706-2015&w=06172015&lang=eng
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 22 june 2015.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: arjohuntleigh akron tilt table
medical device manufacturer, arjohuntleigh, has issued a medical device safety alert concerning its akron tilt table [model number: a8652, a8652t; serial number: between p0167499 and p0418644].
the manufacturer received a customer complaint related with akron tilt table middle section frame breakage in its post-market surveillance monitoring. the investigation showed that one of critical welds in the part was missing. there was no injury related to this incident.
according to the manufacturer, the issue is related with potential hazard for patients and if the affected device will be used it can lead to collapse during movement to the vertical position. in the worst case, scenario user can fall down with the upholstery (if not protected with belts).
the manufacturer will arrange a service technician to visit the facilities to carry out welds presence verification and the frame replacement if a missing weld/missing welds would be detected. it is not recommended to use the couch until action would be taken by the manufacturer.
the affected customers are instructed to ensure that all caregivers and users of the affected devices are made aware of the field safety notice and all listed devices at their facilities are available to be corrected during service technician visit.
according to the local supplier, the affected products are distributed in hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 23 may 2018.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: maquet system cs 100, cs100i and cs 300 intra-aortic balloon pumps
the united states food and drug administration (fda) has issued a medical device safety alert concerning system cs 100, cs100i and cs 300 intra-aortic balloon pumps (iabps), manufactured by maquet. the affected devices are identified as follows:
cs100i iabp [part number: 0998-uc-0446hxx; 0998-uc-0479hxx]
cs100 iabp [part number:0998-00-3013-xx; 0998-uc-3013-xx]
cs300 iabp [part number: 0998-00-3023-xx; 0998-uc-3023-xx]
this field correction also applies to any system 98 or system 98xt iabp that was converted to a cs100i or cs300 iabp.
the manufacturer received a complaint that has been associated with a patient death due to the failure of the device to initiate therapy. this complaint involved a cs300 iabp that did not pump due to an electrical test failure code #58 (power up vent tests fail), maintenance code #3, and an autofill failure. an electrical test failure code #58 is caused by a solenoid valve requiring more power than the solenoid driver board can deliver to open the valve.
the manufacturer indicates that the risk-benefit of using an affected cs100i, cs100 or cs300 iabp should be assessed by the medical team for each patient when no alternative iabp or alternative therapy is available. affected users are instructed to adhere to the following instructions when using affected devices:
pursuant to the user instruction warnings, clinicians are instructed not to leave the patient unattended during iabp therapy.
an additional hazard associated with a sudden shutdown is related to the static condition (no inflating or deflating) of the balloon during the interruption of therapy. it is important to note the following warning in the cs100i, cs100 or cs300 iabp operating instructions manual:
warning: the patient balloon should not remain inactive in the patient (i.E., not inflating or deflating) for more than 30 minutes due to the potential for thrombus formation.
until the service is performed, the manufacturer recommends powering on the iabp prior to inserting the iab catheter to allow the iabp to successfully complete its self-test. this action will take less than 60 seconds to perform. in the event the iabp fails to successfully complete the self-test and exhibits electrical test failure code 58, affected users should remove the iabp from service and contact the manufacturer.
a service representative will be replacing the defective solenoid driver boards. affected users having affected iabp unit(s) will be contacted by the manufacturer to schedule on-site service.
for details, please refer to the fda websites:
https://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm563615.Htm
https://www.Fda.Gov/safety/recalls/ucm563583.Htm
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 20 june 2017.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: maquet servo-air
the medicines and healthcare products regulatory agency (mhra) of the united kingdom posted a field safety notice concerning servo-air, manufactured by maquet [article number: 66 82 000]. all serial numbers with currently released software version 1.00.03 or older are affected.
under certain conditions, the manufacturer has identified that an internal communication error might prevent the execution of the automatic failure handling process. as a consequence, ventilation will stop and a high priority alarm will be triggered. the manufacturer is aware of two instances where this issue has led to patient injury.
according to the manufacturer, under normal circumstances, if a software-related error is detected, the system will resolve it automatically while ventilation continues uninterrupted. this issue will stop ventilation, with the safety and the expiratory valves open, thus allowing the patient to breathe freely, but without ventilator support. the high priority technical error alarms te43, te78, te80 and te81 will be activated simultaneously.
a new system software version 2.01.02 that will correct this behavior is being developed. the manufacturer will initiate an immediate update of all affected servo-air units as soon as the system software version 2.01.02 is released.
the servo-air ventilator can be used in accordance with the instructions for use, with extra attention to the following:
never leave the patient unattended when connected to the ventilator system.
make sure that a resuscitator is readily available.
act as instructed on alarms.
in case of a technical error te43, te78, te80, te81 replace the ventilator immediately and contact the manufacturer’s representative.
for details, please refer to the following link:
https://www.Gov.Uk/drug-device-alerts/field-safety-notice-02-to-06-october-2017
if you are in possession of the affected product, please contact your supplier for necessary actions.
posted on 10 october 2017.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: maquet venous bubble trap vbt 160 and custom tubing sets containing the venous bubble trap vbt 160
the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice (fsn) concerning bubble trap vbt 160 and custom tubing sets containing the venous bubble trap vbt 160 manufactured by maquet cardiopulmonary ag. the following products are affected:
venous bubble trap; vbt 160 (sterile single product)
venous bubble trap; vbt 160 u (unsterile single product)
custom tubing sets containing the vbi 160: bejbeo-vbt (bioline coating)
custom tubing sets containing the vbt 160: bo-vbt (softlinf coating)
the manufacturer received complaints from several customers who reported that during use, the venous bubble trap (vbt) draws air into the system. internal investigation by the manufacturer confirmed the customer reports and it was determined that a manufacturing defect in the production of the bubble trap is responsible for the intrusion of air into the system during use.
as the main function of the vbt is to remove air from the system during use, the manufacturer considers this defect to present an unacceptable increased level of risk for the patient. if unaddressed, this could result in air entering the circulatory system of the patient and causing severe injury and the possibility of death.
the manufacturer has received no reports that the defect present in the vbt has resulted in a serious injury or death to any patient.
users of the affected products were advised to take the actions mentioned in the fsn.
for details, please refer to mhra website: http://www.Mhra.Gov.Uk/home/groups/fsn/documents/fieldsafetynotice/con445987.Pdf
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 19 august 2014.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: maquet cardiovascular flow-i anaesthesia system
the united states food and drug administration (fda) has issued an alert concerning flow-i anaesthesia system, manufactured by maquet cardiovascular. [model numbers: c20 (for united states), c30 and c40; part numbers: 66 77 200 (united states only), 66 77 300 and 66 77 400; serial numbers: 2743, 2852, 2854, 2855, 2856, 2858]
according to the manufacturer, the system is intended for use on neonatal to adult patient populations in hospital environments, except mri environment by healthcare professionals trained in inhalation anesthesia administration.
electrical issues in the control, monitoring or panel sub-systems, caused by the printed circuit boards (pcbs) that control the sub-systems. the problems manifested as multiple re-starts of the sub-systems and, in a few instances, disabling of the system has occurred. replacement pcbs are now available to correct the issues.
for details, please refer to the fda website:
http://www.Accessdata.Fda.Gov/scripts/enforcement/enforce_rpt-product-tabs.Cfm?action=select&recall_number=z-0804-2016&w=03022016&lang=eng
posted on 7 march 2016.
Czech data is current through July 2018. All of the data comes from the Czech Public Registry of Medical Devices, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and the Czech Republic.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: maquet flow-i anesthesia system c20, c30, c40
the united states food and drug administration (fda) has issued a class i recall concerning flow-i anesthesia system c20, c30, c40, manufactured by maquet medical systems usa.
this action only affected flow-i anesthesia systems distributed between may 2010 and december 2011. in specific c20, c30 and c40 flow-i anesthesia systems, if the man/auto switch was not fully engaged in either an "on" or "off position, but rather was placed in an "in- between position" for more than five seconds, a technical alarm te 613 may have been generated. activation of the technical alarm te 613 causes the system to remain in the original mode selected and does not switch the ventilation mode. to deactivate the technical alarm te 613, the system must be restarted. the corrective action associated with this field correction included upgrading the affected systems' software as well as providing new corresponding user's manuals.
for details, please refer to fda website http://www.Fda.Gov/safety/recalls/ucm310815.Htm
if you are in possession of the affected product, please contact your supplier for necessary actions.
posted on 9 july 2012.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: maquet heart-lung machine hl 30
medical device manufacturer, maquet cardiopulmonary ag issued a medical device safety alert concerning heart-lung machine hl 30.
the manufacturer has identified two potential issues with the hl30 devices which will be addressed in a software upgrade:
first, in rare instances, as a result of an accidental impact or 'bump' to the pump head cover, the unit may stop. this stoppage is intended to occur by design, whenever the pump head cover is opened during operation. however, if the impact is rapid, the unit may stop without an informational message explaining the reason behind.
second, there is a software anomaly in the cardioplegia module whereby, in a limited number of cases, the unit slave pump did not engage after cardioplegia pause.
no patient injury has been reported in either issue.
the local supplier confirmed that the affected products have been distributed in hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 8 february 2013.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: maquet servo-i/s ventilator systems with software version 8.00.00
the australia therapeutic goods administration (tga) has issued a medical device safety alert concerning servo-i/s ventilator systems with software version 8.00.00 [part numbers: 68 85 247, 68 85 259].
the manufacturer has become aware of improper behaviour introduced in servo-i and servo-s ventilator system sw version 8.00.00, which appears as follows:-
if ventilation is started with infant factory default settings, the following settings will apply: pressure control mode; and 10 cmh2o pc above peep.
the system will deliver a pressure of 20 cmh2o above peep as long as the factory default setting 10 cmh2o is used unchanged.
according to the manufacturer, there is a risk of serious injury to an infant. however, the issue would be apparent in the pressure curve and peak pressure displayed on the screen. there are no reported injuries.
users are advised to change the default settings of pressure above peep in the infant patient category. the ventilator will only deliver a pressure of 20 cmh2o above peep if the default start-up configuration of the pressure has not been changed. the manufacturer will be upgrading all affected units as a permanent correction.
according to the local supplier, the affected products are not distributed in hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 17 june 2016.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: gi dynamics endobarrier gastrointestinal liner system
the medicines and healthcare products regulatory agency (mhra) of united kingdom has posted a medical device safety alert concerning endobarrier gastrointestinal liner system, packaged, sterile us [part number: 40-10-00624], manufactured by gi dynamics (gid).
due to the incidence rate of hepatic abscess (ha) in the united states (us) investigational device exemption endo trial exceeding the established safety threshold of 2%, the study was terminated by gid prior to completion.
the manufacturer and the us food and drug administration (fda) have come to a mutual agreement to conclude the endo trial as of 30 july 2015. with seven cases of hepatic abscess in the endo trial, the incidence rate is approximately 3.5%, which exceeds a previously established safety threshold of 2%.
the overall historical rate of hepatic abscess in markets outside the us is approximately 0.94% based on experience with approximately 3,200 units shipped commercially since 2009. this rate reflects an increase from 0.49% observed globally two years ago, but is still low and below the 2% threshold established for the treatment. all reported cases of ha that developed after endobarrier implantation have been fully resolved upon device removal.
the manufacturer will immediately begin explanting the device from all remaining endo trial participants and closing out the endo trial. the manufacturer expects to complete all explants by the end of october. endobarrier will continue to be available to patients who need it in all countries around the world where it is approved for commercial use.
physicians are advised to continue to educate patients on the early signs of ha (e.G., right upper quadrant pain, abdominal pain, fever/chills/malaise) and remind them to seek immediate treatment and resolution to mitigate any complications should they be present.
for details, please refer to the mhra website:https://www.Gov.Uk/government/publications/safety-information-from-manufacturers-field-safety-notices/field-safety-notices-28-september-to-2-october-2015
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 6 october 2015.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: hager & werken brilliant mouth mirror no. 4
the medicine and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning brilliant mouth mirror no.4, manufactured by hager & werken gmbh & company kg.
the manufacturer is recalling its mouth mirrors no.4 with the item code 605400 and lot number md-4/31. the mirrors could mistakenly be removed out of the frame, if this occurred it could lead to a significant risk to the patients.
for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/index.Htm
if you are in possession of the products, please contact your supplier for necessary actions.
posted on 09 may 2012.