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
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Medical device safety alert: verathon glidescope reusable gvl, avl, and ranger blades
medical device manufacturer, verathon, has issued a field safety notice concerning all serial numbers of glidescope reusable gvl, avl, and ranger blades.
this safety alert applies to all models of glidescope reusable blades currently in the field: reusable gvl 2 0574-0010, gvl 3 0574-0007, gvl 4 0574-0001, and gvl 5 0574-0030; avl reusable 2 0574-0118, avl reusable 3 0574-0115, avl reusable 4 0574-0116, and avl reusable 5 0574-0117; and ranger gvl 3 0574-0029, ranger gvl 4 0574-0028, and ranger gvl 4 with 2 foot cable 0574-0018. it does not apply to single use systems, including video batons and stats.
the manufacturer has become aware that glidescope video laryngoscope customers continue to use reusable laryngoscope blades even when the blades show signs of serious wear and tear.
the statement instructing users to inspect and monitor the product is currently located in the middle of the user’s manual under general maintenance information. this statement may not be sufficiently prominent to ensure that users do, in fact, inspect blades for wear and tear. therefore, verathon initiated a voluntary correction to strengthen the product labeling for all glidescope reusable blade. the manufacturer is highlighting the following warning statement in the user guide: "to ensure patient safety, routinely inspect the glidescope video laryngoscope blade before and after every use to ensure the blade is free of rough surfaces, sharp edges, cracks, protrusions, or any other indication of wear. if found, do not use the damaged or worn blade, otherwise blade breakage may occur which could cause patient injury or death. always ensure that alternative airway management methods and equipment are readily available."
if you are in possession of the products, please contact your supplier for necessary actions.
posted on 27 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
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Medical device safety alert: verathon glidescope gvl video laryngoscope reusable blades
the united states food and drug administration (fda) posted a firm press release concerning glidescope gvl video laryngoscope reusable blades, manufactured by verathon inc.
the manufacturer initiated a voluntary recall of glidescope gvl video laryngoscopes reusable blades that were manufactured between december 2010 and august 2011. the recall includes the following models within the specified serial number ranges: glidescope gvl 3, 0574-0007: md10500 to md112387; glidescope gvl 4, 0574-0001: lg105000 to lg112758 and glidescope gvl 5, 0574-0030: xl105000 to xl111798.
the firm voluntarily recalled the products after learning about design characteristics leading to cracked and broken blades. these laryngoscope blades have been found to be prone to developing cracks and/or breaking across the tip of the blade, which potentially could result in pieces of the blade breaking off in patient’s mouths and obstructing the airway or being swallowed.
the manufacturer suggests healthcare facilities that have glidescope gvl recalling reusable blades to stop using the blades and contact verathon customer care to obtain a replacement blade.
for details, please refer to the following fda website:
http://www.Fda.Gov/safety/recalls/ucm330305.Htm.
if you are in possession of the affected product, please contact your supplier for necessary actions.
posted on 3 december 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
Field safety notice: salter labs 7600 bubble humidifier used with supplemental oxygen therapy
the food and drug administration (fda), united states, has issued a class i recall on salter labs 7600 bubble humidifier (350cc volume with 6psi safety valve).
the manufacturer of the device, salter labs, found that in certain lots of the 7600 bubble humidifiers, the humidifier lids failed to pop off at the intended pressure. also, when the pop-off does occur, the brass slug does not always reseat to the appropriate position. when the slug fails to reseat properly, the humidifier can leak.
for conscious adult patients and in hospital settings with well trained personnel, the leak characteristic of this defect would be obvious. however, for an unconscious, critically ill patient, or for an infant, or child patient, or a home care patient, the leaking may not be obvious to the patient or to the caregiver in a home care situation. a humidifier leak will potentially interrupt the flow of supplemental oxygen to the patient. hypoxemia may develop resulting in death or serious adverse health consequences.
for details, please visit the following fda website:
http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm291785.Htm.
if you are in possession of the 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: rudolf medical gmbh laparoscopic instruments
medical device manufacturer, rudolf medical gmbh, has issued a medical device safety alert concerning its laparoscopic instruments. the item numbers and descriptions of the affected products as follows:-
ru 0385-xx and ru 0363-xx: bended laparoscopic inserts with tube (ø 5.00 mm)
rs 003-xx: laparoscopic inserts with tube ( ø 3.00 mm)
rs 002-xx: laparoscopic inserts with tube ( ø 2.00 mm)
according to the manufacturer, a customer complaint brought to their attention that during reprocessing, the inner lumen of these laparoscopic inserts cannot be flushed out sufficiently with the recommended rinsing tip. further investigation showed that all inserts, which cannot be disassembled – as listed above - are affected. risk of infection exists.
the manufacturer advises users of the followings:
for affected ru 0385-xx; ø 5.00 mm
in order to prevent any further hazard issues, the manufacturer has redesigned the bended laparoscopic inserts. the improved version can be disassembled and therefore it can be cleaned effectively according the standard cleaning procedure for straight laparoscopic instruments.
the new design is more delicate and can therefore not provide as much tensile strength as the previous design. users should be aware about this limitation of the new instruments.
in return of the old type of bended laparoscopic instruments, affected users will receive the redesigned insert version.
for the affected rs 003-xx; ø 3.00 mm
since the laparoscopic instruments with ø 3.00 mm are too thin for this type of redesign, the manufacturer will discontinue the 3.00 mm laparoscopic instruments for now in their portfolio, until they have developed an alternative, which can be disassembled.
in exchange, the manufacturer offers affected users the same type of inserts but in the size of ø 3.50 mm. these laparoscopic instruments can be disassembled as well.
for the affected rs 002-xx; ø 2.00 mm
since the laparoscopic instruments with ø 2.00 mm are far too thin for this type of redesign, the manufacturer will cancel the 2.00 mm laparoscopic instruments for now from their portfolio, until an alternative, which can be disassembled, has been developed.
in exchange, the manufacturer offers affected users the dismountable laparoscopic instruments with ø 3.50 mm.
regardless of the time of purchase, any of the above mentioned laparoscopic inserts, which are returned, will be replaced with their alternatives.
according to the manufacturer, 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 06 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
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Medical device safety alert: siemens acuson sc2000 ultrasound systems
the australia therapeutic goods administration (tga) posted a medical device safety alert concerning acuson sc2000 ultrasound systems manufactured by siemens ltd.
according to the manufacturer, the user interface module on the ultrasound system consists of the console (monitor, control panel and keyboard) and the swivel mechanism.The swivel mechanism is used for adjusting the height and rotation of the console and is attached to the column on the ultrasound system. if the connection of the user interface module to the column on the ultrasound system is loose, the entire module may fall off the ultrasound system resulting in injuries.
the manufacturer advises end users to inspect their units for any looseness in the attachment of the interface module to the column on the ultrasound system. if looseness is observed, the user should discontinue use of the device immediately and contact the manufacturer. a service engineer will perform the necessary repairs.
for details, please visit the following tga website:
http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2014-rn-00005-1
if you are in possession of the affected product, please contact your supplier for necessary actions.
posted on 7 january2014.
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
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Medical device safety alert: rudolf medical gmbh continuous-flow outer sheath for resectoscope
medical device manufacturer, rudolf medical gmbh, has issued a medical device safety alert concerning its continuous-flow outer sheath for resectoscope [item number: rc260-111, rc220-111].
a customer complaint brought to the manufacturer’s attention that during surgery, irrigation was not possible because the irrigation connections on the outer and inner shaft are not in the corresponding place. further investigation showed that this issue is caused by a general mix-up of the outer shaft geometry. this represents a potential safety risk which could lead to the lengthening or rescheduling of the surgery.
the manufacturer advises affected users to quarantine the concerned items in stock.
according to the manufacturer, 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 30 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
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Medical device safety alert: sam medical products junctional tourniquet
the united states food and drug administration (fda) posted a medical device safety alert concerning the accessory (axilla) strap for the sam junctional tourniquet (sjt), manufactured by sam medical products.
according to the fda, the manufacturer notified affected users of a voluntary recall to address a potential issue with a clip used to secure the accessory strap used for the axilla application of the sjt.
if this piece were to fail in actual use the operator may face a potential delay in using the sjt in the axilla area. all other indications of the sjt (inguinal hemorrhage and pelvic fracture) are not impacted by this issue. the manufacturer is replacing the current axilla straps with an updated version.
the manufacturer has not received any reports of patient injuries to date related to this issue nor has it been reported to fail during actual patient use.
for details, please refer to the following fda websites:
http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm417985.Htm
http://www.Fda.Gov/safety/recalls/ucm417940.Htm
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 09 october 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
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Medical device safety alert: schiller medical fred easy & fred easy life defibrillators
the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning fred easy & fred easy life defibrillators manufactured by schiller medical.
according to schiller medical, two problems have been identified regarding “transistor charge error” message and quality of the electrodes.
transistor charge error:
on some devices, during use, or during a self test, a message “transistor charge error” has occurred. in the analysed cases (field and laboratory results), all occurrences were “false positive”, the devices were not affected by a failure. as a consequence, the device is unavailable until it is restarted. the occurrence of the failure is estimated to 0.2%.
the corrective action consists in a software update, which prevents the occurrence of the “false positive”.
electrodes:
a decline in the quality, before expiry date, has been observed for some schiller electrodes manufactured by nessler (p/n 0-21-0000, 0-21-0003, 0-21-0020, 0-21-0021, 0-21-0013, 0-21-0024, 2.155056, 2.155057, w1410241, w1404262). the consequences were a decrease of survival chances for some patients, due to the lack of heart rhythm analysis.
all schiller electrodes which are still on the market, with a valid expiry date and manufactured by nessler, will be exchanged by new schiller electrodes manufactured by leonhard lang.
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/fieldsafetynotices/index.Htm
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted 22 may 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
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Medical device safety alert: schiller fred easyport
the medicines and healthcare products regulatory agency (mhra) of the united kingdom posted a medical device safety alert concerning fred easyport (an automatic external defibrillator) manufactured by schiller. the affected article number is 0.900000 and the affected products are sold from 2004 to 2016.
according to the manufacturer, the device can be categorised into three categories according to its configuration:
first category: has manual mode of analysis and can override the analysis in order to shock based on user’s decision.
second category: has manual mode of analysis and shock delivery by user, if suggested by the device. analysis cannot be overridden but can be initiated again at any time.
third category: does automatic analysis every two minutes which cannot be overridden by user.
the manufacturer has received an incident report relating to a device of the third category where the ecg trace showed a ventricular fibrillation. the device decided for a shock delivery correctly. during the loading of capacitor the device analysed further and due to the short change of rhythm the device diverted the shock internally and asked the user to resume cardiopulmonary resuscitation (cpr) immediately.
the device in question (third category) had a special feature of automatic analysis every two minutes. however, the standard device (first and second categories) analyses upon pressing the “analysis” button. the user is prompted to do so every two minutes. in the present case the user got confused and did not allow for the further automatic rhythm analysis after two minutes. the user continued with cpr, so the device noted motion artefacts and thus could not analyse the trace anymore. therefore, no shock was delivered.
the manufacturer advises that:-
for the first and second categories of device: users can use the device without any restriction. however, new software upgrade to ver. 3.14 is recommended at next service of device.
for the third category of device: new software upgrading shall be completed upon receipt from the manufacturer of the new software version 3.14.
with the new software version 3.14, there will be no automatic re-analysis during charging of capacitor; therefore, this potential risk will be eliminated.
for details, please refer to the mhra website:
https://www.Gov.Uk/drug-device-alerts/field-safety-notices-9-may-13-may-2016
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 18 may 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
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Medical device safety alert: schiller medical cardiovit at-102 plus
medical device manufacturer, schiller medical, has issued a medical device safety alert concerning its cardiovit at-102 plus (software version: 1.21; 1.22 or 1.23 and article number: 0.075000)
it has recently come to the manufacturer’s attention that patient data mix-up may happen when the setting of “manual send” and “automatic erase after send” is chosen for the data transmission.
according to the manufacturer, electrocardiography (ecg) data interchange only happens with this particular setting. all other settings are not affected. the occurrence is evaluated as rare, considering the limited number of incident reports in relation to the number of ecgs made per year and due to the fact that most customers use auto transmission, and additionally to the fact that data interchange is not likely to happen if the patient is released from the cables before the manual ecg transmission is started.
the affected users are advised to check their stock and devices on the field to identify the software version of cardiovit at-102 plus. if the software version is either 1.21, 1.22 or 1.23, they need to take actions as recommended below. until receiving a new software version of cardiovit at-102 plus from the manufacturer, affected users are advises to take one of the following three settings to prevent the occurrence of the patient safety issue:
automatic send with automatic erase of data after sending
automatic send without automatic erase of data after sending
manual send without automatic erase of data after sending
the manufacturer will deliver a new software version to address this issue and will be released by february 2017.
according to the manufacturer, the affected products are not distributed in hong kong.
if you are in possession of the products, please contact your supplier for necessary actions.
posted on 8 february 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
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Medical device safety alert: schiller medical sas fred easy
the health sciences authority (hsa) has issued a medical device safety alert concerning fred easy, manufactured by schiller medical sas [reference: 4-07-0001; lot number hyb 16-0056, hyb 16-0057, hyb 16-0058 and hyb 16-0059; between october 1, 2016 and january 15, 2017].
according to the manufacturer, users have reported some new batteries causing the failure "battery empty" when inserted into a defibrillator fred easy. batteries with this fault cannot be used. the fault is detected automatically by the fred easy when the battery is inserted into the device.
the batteries of these lots must be tested, using the procedure described below, to verify that they can be used in their fred easy:
insert the battery into fred easy (see section 3.1 "inserting the battery" in the fred easy user manual). the unit performs its self-test. at the end of the self-test, it shuts down and its green led flashes: in this case, the battery is free from defects and can be used without limitation.
however, if after the self-test of fred easy the green light remains off and the display shows: the battery is defective. in this case, contact schiller distributor immediately, to get replacement.
for details, please refer to the hsa website:
http://www.Hsa.Gov.Sg/content/hsa/en/health_products_regulation/medical_devices/product_owners_fsn/2017/january.Html
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 6 february 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
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Medical device safety alert: schiller medical, monitor/ defibrillator defigard touch7
the health sciences authority (hsa), singapore posted a medical device safety alert concerning monitor/ defibrillator defigard touch7 [all devices with software version up to “soft 5” are affected].
the defigard touch7 can be configured in 3 different start modes (monitoring, aed or manual defibrillator). the field safety notice concerns devices configured in start mode “manual defibrillator’.
if the user starts the device in this configuration, and switches directly from the manual defibrillation to the synchronized defibrillation mode, without ecg patient cable being plugged, then the device will be unable to trigger the synchronized defibrillation shock. this can be seen on the screen of the device, no trigger pulses are available. if the patient cable is connected, according to the user manual, this failure does not occur.
according to the manufacturer, it may be unable to perform synchronized defibrillation therapy. the manual defibrillation mode at start is a specific medical emergency service setting. it is used when rescuer wants to mainly use the device as manual defibrillator. the synchronized defibrillation is not an emergency procedure, and it is recommended to perform it with ecg patient cable.
while waiting for the update of the defigard touch 7, affected users are advised to continue to use it without restriction. if user startup configuration with manual defibrillation mode, user has to select another startup mode, until the update to software “soft 6”, or use a patient cable for the synchronized defibrillation therapy, as described in the user manual.
for details, please visit the following hsa website:
http://www.Hsa.Gov.Sg/content/dam/hsa/hprg/medical_devices/updates_and_safety_reporting/field_safety_corrective_action/fsn/2017/november/hsa%206004101-056-17-06_36%20fsn_redacted.Pdf
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 30 january 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
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Medical device safety alert: paul hartmann vivano med foam abdominal kit st p3
medical device manufacturer, paul hartmann ag, has issued a medical device safety alert concerning its vivano med foam abdominal kit st p3. the affected device’s product reference number is 409 721/2 and the lot number is 408584-1902001.
vivano med foam abdominal kits are wound dressing sets for the negative pressure wound care in conjunction with a vivano tec negative pressure therapy system. these include in addition to the hydrophobic pu foam dressing a pe organ protection layer. the organ protection layer is a round, micro-perforated polyethylene film (ø 65 cm) with 6 welded application pockets, which are designed to facilitate the introduction of this organ protection layer between the abdominal wall and the internal organs.
in the manufacturer’s internal routine controls, a deviation in the manufacturing process for the above mentioned organ protection layer has been identified. this could lead to a lower stability of the weld seams, which connects the application pockets to the pe organ protection layer. an increased mechanical load could lead to a potential risk that one of the applicator pockets could be detached.
the manufacturer advises users to examine their inventory, not to use the affected products and return them to the manufacturer.
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 13 march 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
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Medical device safety alert: hartmann disposable surgical gown recall
paul hartmann (asia-pacific ltd) has initiated a recall concerning certain lots of the hartmann foliodress gown under the following trade names:-
comfort basic;
comfort perfect;
comfort special;
protect standard;
protect reinforced;
protect a standard;
protect a reinforced;
according to paul hartmann (asia-pacific ltd), a quality inspection revealed the individual occurrence of micro-holes in a number of blisters containing sterile surgical gowns and isolation gowns. the micro-holes are unlikely to be detected through visual inspection. as a result, the sterility of affected products may be compromised. paul hartmann (asia-pacific ltd) advises users not to use the affected products any longer. product recall is on-going.
according to paul hartmann (asia-pacific ltd), the affected products were distributed in hong kong.
if you are in possession of the affected product, please contact your supplier for necessary actions.
posted on 23 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
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Medical device safety alert: sekisui diagnostics acetaminophen l3k assay
medical device manufacturer, sekisui diagnostics, has issued a medical device safety alert concerning its acetaminophen l3k assay [list number: 506-10 (lot numbers: 47677, 47694, 47649, 47650, 47662, 47663, 48253, 48385, 48386) and 506-30 (lot numbers: 47695, 48294)]
abbott diagnostics has received a field safety notice (fsn) from sekisui, the manufacturer of acetaminophen reagent. according to the fsn, sekisui has investigated complaints related to the formation of crystals in the r2 reagent and/or shift of controls when left on board an automated analyzer. during the investigation, it was determined that when the r2 reagent is exposed to the atmosphere for prolonged periods of time, on board an automated analyzer, crystals may form. sekisui has identified the crystals form a standard component of the reagent. the amount of time to crystalise is dependent on reagent usage, temperature, and length of time on board the analyzer.
abbott internal testing has shown that the crystal formation does not impact architect csystem instrument performance.
sekisui has made the decision to reduce the expiration date of the acetaminophen l3k reagent, catalogue number 506-10 and 506-30, to 9 months from 18 months due to the findings during the investigation. to date, no impact to patient results has been identified. a review of previously reported patient results is not required, however, if affected users chose to do so, they are instructed to follow their standard laboratory protocol.
affected users are advised to take the following actions:-
discard all reagent in house with a current expiration date of 2016-09.
update the expiration on all remaining kits on hand with the expiration dates provided by the manufacturer.
reagent requires a daily (24 hour) calibration.
reagent should remain on the abbot architect analyzer for a maximum of 8 days.
use a minimum volume of 20ml of r2 reagent at a time, using only 20ml wedges. when adding additional reagent to the analyzer use a new wedge.
if crystals are observed within reagent stored on-board, reagent should be discarded and replaced with fresh reagent.
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 29 january 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
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Medical device safety alert: sentreheart lariat suture delivery device
the united states food and drug administration (fda) has issued medical device safety alerts concerning lariat suture delivery device, manufactured by sentreheart.
the fda is alerting health care providers and patients of reports of patient deaths and other serious adverse events associated with the use of the lariat suture delivery device and its associated devices to close the left atrial appendage, a pouch-like region of the left atrium in the heart, in patients with irregular heart rhythm (atrial fibrillation) to prevent stroke.
the fda identified 45 adverse events through june 30, 2015 that occurred in patients undergoing left atrial appendage (laa) closure procedures with the lariat suture delivery device and/or its associated devices. these reports describe six patient deaths and other serious medical complications including laceration and/or perforation of the heart, complete laa detachment from the heart, bleeding (hemorrhage), low blood pressure (hypotension), fluid collection around the heart (pericardial effusion), fluid collection around the heart that causes low blood pressure and decreased heart function leading to shock (cardiac tamponade), and fluid collection around the lung (pleural effusion). of the 45 adverse events reported to the fda, 34 (approximately 75%) resulted in the need to perform emergency heart surgery.
to reduce the risk of stroke in patients with atrial fibrillation, the fda advises healthcare professionals to consider treatment options for which safety and effectiveness have been established. prior to treatment, health professionals should inform atrial fibrillation patients of the benefits and risks of the available treatment options to help prevent stroke.
for details, please refer to the fda websites:
http://www.Fda.Gov/medicaldevices/safety/alertsandnotices/ucm454501.Htm
http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm454660.Htm
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 14 july 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
Mhra field safety notice: mindray v series patient monitor
the uk medicines and healthcare products regulatory agency (mhra) issued a field safety notice to alert healthcare providers and customers that a software anomaly contained in the v series monitor manufactured by mindray.
according to the manufacturer, in rare instances, a system database corruption may occur that may cause the v series monitor to reset. the system will return to monitoring after 90 seconds, however, the database corruption may persist. should the database corruption persist, established patient settings may be incorrect and established alarm settings, including those related to arrhythmias, may be incorrect or not available. patient data may not be displayed or only partially displayed.
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 affected products, please stop using them and 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: beneheart d1 defibrillator/ monitor
the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning beneheart d1 defibrillator/ monitor, manufactured by mindray. the affected product is beneheart d1 with the first four digits of the serial number as fq37/ fq38/ fq39/ fq3a/ fq3b/ fq3c/ fq41/ fq42/ fq43/ fq44/ fq45/ fq46/ fq47.
the manufacturer has identified the affected aeds might fail to boot. when this issue occurs, the status indicator of the aed is off. the reason for the startup failure of the aed is due to abnormal reset of the power management circuit on the main control board.
the manufacturer advises affected users to discontinue use of the aed. the manufacturer will repair the affected aeds as soon as possible.
for details, please refer to the following link:
http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con473632
according to the manufacturer, the affected products were distributed in hong kong.
if you are in possession of the affected product, please contact your supplier for necessary actions.
posted on 18 november 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: mindray v series patient monitors
the medicine and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning the v series monitor, manufactured by mindray ds usa, incorporation.
the manufacturer has identified two software anomalies contained in the v series monitoring system. these anomalies occur only when a vps module is connected to v12 or v21 monitor that has been monitoring a patient of a different size than the one used by the vps module. when a vps module is inserted into a v12 or v21 monitor, the two components can be synchronized so they use either the vps or the monitor settings. the two software anomalies can be summarized as follow:-
a software anomaly causing the non invasive blood pressure inflation pressure and arrhythmia algorithm settings to operate based on the settings associated with the patient size previously used on the monitor instead of using the settings associated with the patient size imported from the vps.
a software anomaly causing the system to utilize incorrect departmental defaults.
the manufacturer advised that vps modules should not be used between systems until the software upgrade has been completed.
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 affected products, please contact your supplier for necessary actions.
posted on 19 june 2012.