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: smith and nephew birmingham hip modular heads
medical device manufacturer, smith and nephew, has issued a field safety notice concerning birmingham hip modular heads.
according to the manufacturer, the average revision rate for the birmingham hip modular head with all stems is currently 1.29 revisions per 100 observed component years in the national joint registry of england and wales and 1.12 revisions per 100 observed component years in the australian orthopaedic association’s national joint replacement registry. these rates exceed the 1% benchmark revision rate established by the uk’s national institute for health and clinical excellence. however, if combined with the uncemented synergy stem, the revision rate is 1.07 revisions per 100 observed years which is acceptable and comparable to other clinically successful hip implants on the market.
owing to the above reason, the manufacturer has updated the device’s instructions for use (ifu) (lit. no. 81036947 rev d 03/10 for the application of the birmingham hip modular head). a new stand-alone ifu for the affected product is issued, which includes updates on the contraindications, indications and additional warnings. the sections “information on hydroxyapatite implants” and “information on porous coated implants” that are specific to cups have been removed from the ifu.
furthermore, the manufacturer advised users to use the affected product only in accordance with the revised indications for use in the revised ifu.
according to the local supplier, the affected devices were distributed in hong kong.
if you are in possession of the products, please contact your supplier for necessary actions.
posted on 25 september 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
Press release
Causa
Recall of microbial contaminated protective wipes and adhesive removers
annex
the department of health (dh) today (april 15) endorsed a local medical device supplier, smith & nephew (s&n) ltd's proposal to recall eight types of its devices imported from the states (see annex) because of a potential for pathogenic contamination.
a dh spokesman explained that the eight products belonged to two categories. the first comprises five types of protective wipes, used for skin preparation before the removal of tapes and films. the second consists of three types of adhesive removers which can clean adhesive residues from the skin.
the spokesman said, "s&n's initiation comes following the dh's earlier call this january, advising the public not to use a us manufacturer, triad group's alcohol swab preparations after the us food and drug administration's blanket market recall of the items because of the potential risk of contamination by a bacterium, bacillus cereus. at the same time, local medical device traders are advised to check if any of their products have been affected as a consequence."
bacillus cereus is known to be able to cause life-threatening infections among at-risk populations, including surgical and immuno-compromised patients. thus far however, the dh has not been notified of any such infections.
s&n alerted the dh that its parent company in the states, smith & nephew inc, has just announced a global recall on the above eight products as the items were also manufactured by the triad group and have been found to have the same risk of contamination by bacillus cereus.
the spokesman remarked that in fact s&n had only imported the first two items in the table, remove universal adhesive remover wipes and skin-prep protective wipes for sale in hong kong. therefore, the two would be the major targets of s&n's present recall.
"however, mindful of the option of internet trading and also the possibility of possession by travellers, return of any of the other six items would also be handled," the spokesman clarified.
a hotline 2648 7770 has been set up by s&n for related enquiries.
the spokesman finished by stating that while dh will continue to monitor developments of the triad group recall and s&n's related act in hong kong, patients and healthcare providers are advised to stop using products under recall in hand immediately. they may choose substitutes from alternatives available on the market.
ends/friday, april 15, 2011
issued at hkt 19:25.
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: smith & nephew, tendon stripper, slotted, 5.0 mm i.D. x 12” working length
it has come to our attention that smith & nephew endoscopy has issued a product recall regarding eleven lots of tendon stripper. according to the local supplier, hong kong is affected.
the material of shaft tip (casting) does not meet with the manufacturer’s specification, which could result in rusting of the tendon strippers. this condition could make the device difficult to clean and therefore challenging to adequately sterilize.
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
Field safety notice: smith & nephew 560p high definition camera control unit
medical device manufacturer, smith & nephew inc., issued a field safety notice concerning certain 560p high definition camera control unit [product code: 72201919; serial no.: bbs1203 & bbs1450]. user of the device may experience intermittent loss of video due to a defective board component, which was incorporated during the manufacturing process.
according to the manufacturer, there is a risk of inadvertent damage to non-target tissue while visualization is not functioning correctly if loss of video or display is experienced during the surgical procedure.
according to the local supplier, the affected devices were distributed to hong kong.
for more details, please refer to the attachment. 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
Field safety notice: smiths medical graseby mr10 neonatal respiration monitor
the medicines and healthcare products regulatory agencies (mhra), united kingdom has issued a field safety notice advising users of a voluntary correction of a limited number of graseby mr10 neonatal respiration monitors.
medical device manufacturer, smiths medical, has identified that the three battery straps in the mr10 battery box can become permanently deformed, causing the batteries to make only intermittent contact. if this condition occurs during use, then the mr10 may stop functioning without producing an audible alarm. if this condition occurs during an apnoea event, and if it is not observed that the indicator light is no longer lit, this could result in serious injury or death.
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 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: smiths medical logical hemodraw closed blood sampling systems
the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning logical hemodraw closed blood sampling systems, manufactured by smiths medical.
the manufacturer has become aware of a potential risk of inadvertent introduction of air into the affected device via a porous plug, if the device is used incorrectly. if a user incorrectly orients the zero stopcock when activating the hemodraw reservoir, air can enter the fluid pathway. air in the line, if not properly handled by the clinician, can be introduced into the patient under specific situations, which are highly unlikely according to manufacturer. smiths medical has received no reports of patient injury or death related to this issue.
as a precautionary measure, smiths medical is changing its instruction for use to instruct users to fit a non-vented cap to the stopcock after priming. the field safety notice provides these additional instructions to users who have been supplied the affected products. the manufacturer will also supply users with non-vented caps for the affected devices.
for details, please refer to the following mhra website
http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/
con213146
if you are in possession of the product, please contact your supplier for necessary actions.
posted on 11 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
Medical device safety alert: smiths medical portex bivona inner cannula for bivona adult tracheostomy tubes
medical device manufacturer, smiths medical, has issued a medical device safety alert concerning its portex bivona inner cannula for bivona adult tracheostomy tubes [model/catalogue numbers: brc270, brc275, brc280, brc285, brc290, brca70, brca75, brca80, brca85, brca90; all lot numbers].
the manufacturer has become aware of the potential for compression of the inner cannula to occur as a result of handling or certain cleaning methods used with inner cannulae. compression can result in a shorter overall length. use of an inner cannula which is too short may lead to a build-up of secretions within the end of the tracheostomy tube which may cause infection or occlusion.
the inner cannula should be handled and cleaned with care, and according to the instructions for use (“ifu”).
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 20 april 2015.
Data from Singapore is current through September 2018. All of the data comes from the Health Sciences Authority (HSA), 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 recall data from the U.S. and Singapore.
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: smiths medical cadd-solis ambulatory infusion pumps
medical device manufacturer, smiths medical, has issued a medical device safety alert concerning its cadd-solis ambulatory infusion pumps [model numbers: 2111, 2112, and 2120; serial number 1061043 through 1067598].
the manufacturer has become aware of an issue with an intermittent occurrence of binding of the locking assembly on some cadd-solis pumps. binding of the cassette/ keypad lock can occur after latching the cadd-solis medication cassette reservoir or administration set “disposable” to the pump.
when binding occurs, it can prevent the key from fully rotating the cassette/ keypad lock to the locked (engaged) position. to start an infusion with cadd-solis pump models 2111(grey keypad) and 2112 (yellow keypad), and model 2120 (vip), when in patient-controlled analgesia (pca) mode, the lock must be fully engaged. cadd-solis pump model 2120 will start in all other delivery modes without the cassette/ keypad lock being engaged.
if the user is unable to fully engage the cassette/ keypad lock, then model 2111 and 2112, and model 2120 in pca mode, the keypad will be locked and the pump cannot be started. this could cause a delay in the start of an infusion or interruption in therapy if changing a disposable, while an alternative pump is obtained. a delay or interruption of delivery of pain medication may result in escalation of patient pain based on the underlying condition of the patient.
if users begin to experience resistance when locking a cadd-solis pump or if they are unable to fully engage the cassette/ keypad lock while turning the key, then they are advised to discontinue use of the pump and contact the manufacturer to arrange for repair. if they are not experiencing resistance when locking their cadd-solis pumps, there is no immediate need to return their pumps for repair.
according to the manufacturer, no report of serious injury or death related to this issue has received.
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 28 may 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: smiths medical cadd administration sets with flow stop
medical device manufacturer, smiths medical, has issued a medical device safety alert concerning its cadd administration sets with flow stop. the following products re-order numbers for devices with a device expiration date on or before march 2021 are affected:
21-7321-01, 21-7321-24, 21-7322-01, 21-7322-24, 21-7323-24, 21-7324-01, 21-7324-24, 21-7333-24, 21-7336-01, 21-7336-24, 21-7339-01, 21-7339-24, 21-7359-01, 21-7359-24, 21-7383-01, 21-7383-24, 21-7390-01, 21-7390-24, 21-7391-01, 21-7391-24, 21-7394-01, 21-7394-24, 21-7395-24].
the affected products have the potential to impact flow rate when used with a variety of cadd ambulatory infusion pumps. this may result in under delivery of medication. the manufacturer’s test data indicates that under infusion has the potential to contribute to an average of an additional 5.2% under delivery beyond the +/- 6% stated in the operator’s manual for the cadd pumps.
the manufacturer’s risk analysis identified the following possible serious adverse health consequences with a very remote probability of occurrence:
1) inadequate symptom control (dependent on therapy being delivered). for example: increase in pain or increase in cardiac symptoms (heart rate, rhythm, blood pressure);
2) inadequate treatment (dependent on therapy being delivered). for example: subtherapeutic doses delivered of medication in which a specific volume needs to be infused such as antibiotics, chemotherapy, or nutritional therapy.
the manufacturer concluded that there is a very remote probability that under delivery may occur resulting in patient harm, as all possible levels of patient harm were evaluated to be rare.
the manufacturer is not requesting return of product. the manufacture advises users to continue to monitor for under delivery when utilising the cadd administration sets with flow stop.
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 10 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
Causa
Medical device safety alert: smiths medical medfusion syringe pump model series 3500 and 4000
the medicines and healthcare products regulatory agency (mhra) of the united kingdom has posted a medical device safety alert concerning medfusion syringe pump model series 3500 and 4000, manufactured by smiths medical.
the manufacturer became aware that the thread lock material used on a fastening screw can be ineffective. as a result, the medfusion pump syringe barrel clamp mechanism may loosen and decrease the pump’s ability to accurately detect the outside diameter measurement of the syringe barrel, causing an “invalid syringe size” alarm to occur.
a delay in the initiation of an infusion or an interruption of an active infusion has the potential to result in serious injury or death. the effect to the patient would depend on the patient’s condition, the therapy involved, and the amount of time the therapy would be delayed or interrupted.
the “invalid syringe size” alarm triggered as a result of this potential issue alerts healthcare practitioners to the problem. although no serious injuries or deaths have been reported as a result of this issue, the manufacturer recommends against using the affected devices until repair work is completed.
the users are instructed to locate the affected devices, which would be repaired by the manufacturer.
for details, please refer to the mhra’s website:
https://www.Gov.Uk/drug-device-alerts/field-safety-notice-24-to-28-july-2017
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 2 august 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
Field safety notice: smiths medical voluntary recall for level 1® d/di-60hl normothermic iv fluid administration sets, and hotline® blood and iv fluid warming sets
medical device manufacturer, smiths medical asd, inc., is conducting a product recall for the following products:
a) level 1® d/di-60hl normothermic iv fluid administration sets, and
b) hotline ® blood and iv fluid warming sets (product codes: l-70, l-70ni, l-80, l-270, and l-370).
there was an increasing trend in reports of disconnections of the luer lock connector at the patient end of the tubing on certain sets of the above two products. based on the information provided by the manufacturer, if the luer lock connector disconnects during use, this could result in fluid/ blood loss and/ or a delay in therapy, which could result in patient injury, or while highly unlikely, death. the manufacturer has received no reports of serious injury or death related to the problem.
according to the local supplier, the affected products have been distributed in hong kong.
for details, please refer to the attached field safety notice (a) and field safety notice (b). if you are in possession of the affected products, please contact your supplier for further information and 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: smiths medical medfusion model 4000 syringe infusion pump
the united states food and drug administration (fda) has issued a class i recall concerning all medfusion model 4000 syringe infusion pumps with software versions v1.0 and v1.1 manufactured by smiths medical asd, inc.
according to the fda, systems errors can cause the medfusion 4000 infusion pump to go into an alarm condition and stop running, which can result in a delay or an interruption of patient therapy. for patient receiving critical therapy, a delay or interruption of therapy could result in serious injury and/or death.
for details, please refer to fda website
http://www.Fda.Gov/medicaldevices/safety/listofrecalls/
ucm314282.Htm
if you are in possession of the affected product, please contact your supplier for necessary actions.
posted on 3 august 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: smiths medical bci remote alarm cables
the united states food and drug administration (fda) has posted a medical device safety alert issued by medical device manufacturer, smiths medical asd, concerning its bci remote alarm cables (no=normally open, nc=normally closed), used with 9004 the capnocheck capnography (plus or sleep) system, reorder numbers: ww3398no & ww3398nc [lot no.: ww3398no0820, ww3398no0847, ww3398no0948, ww3398nc0822, ww3398nc0847, and ww3398nc0947]. these cables were distributed in colorado, illinois, indiana, massachusetts, south carolina, and wisconsin from october, 2008 through september, 2012.
the bci remote alarm cables are designed for use with the 9004 capnocheck capnography (plus or sleep) system to transfer alarm signals from the capnocheck capnography system to a remote alarm system.
the manufacturer has become aware that, in rare instances, the bci remote alarm cables (bci cables) are not transferring alarms when used with some remote nurse alarm systems. these products may cause serious adverse health consequences, including death.
according to fda, the manufacturer has notified its customers by an “urgent medical device field safety notice-recall” letter to instruct customers to inspect their inventory and remove all affected devices from use.
for details, please visit the following fda website:
http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm347193.Htm
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 10 april 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: smiths medical portex low dead space connector with sideport
the united states food and drug administration (fda) has issued a medical device safety alert concerning portex low dead space connector with sideport [product reorder no.: 10035-05ps; lot no.: 2553426], manufactured by smiths medical asd, inc. the affected products were distributed in november 2013.
one lot of 3.0mm sized connectors, product reorder no. 10035-05ps, lot 2553426 were placed in packages labeled as 3.5mm. affected users are advised to examine their inventory and remove all affected products.
for details, please refer to the following fda website:http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm400982.Htm
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 13 june 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: vygon protect-a-line iv extension set
the medicines and healthcare products regulatory agency (mhra), united kingdom (uk) issued a medical device alert concerning protect-a-line iv extension set (supplied with vented caps) manufactured by vygon. the affected product code is 0832.04 and all batch numbers ending in the letters ba are affected.
according to the mhra, there is a risk of air embolus because the affected devices have been supplied with vented caps on the female port (y-site) instead of non-vented caps.
identify affected devices.
prior to use, remove vented caps from the female port (y-site) of affected devices and replace them with non-vented caps (or a needle free connector) if this port is to remain unused when the set is connected to a patient.
for details, please visit the following mhra website: http://www.Mhra.Gov.Uk/publications/safetywarnings/medicaldevicealerts/con306143
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 20 august 2013.
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
Mhra field safety notice: octopus-3 x anti-reflux valves + clamps
the uk medicines and healthcare products regulatory agency (mhra) issued a field safety notice to alert healthcare providers and customers that octopus-3 x anti-reflux valves + clamps manufactured by vygon sa may not be able to deliver infusion by gravity.
according to the manufacturer, there is a number of products of batch number 080411ae which may incorporate an anti-syphon valve instead of an anti-reflux valve due to a production error. in the event of a device incorporating an anti-syphon valve being used for a gravity infusion, the infusion will not reach the patient.
the manufacturer is recalling the product. 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 product, please quarantine the remaining stock 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
Field safety notice: ergolet hera ii bathing and toilet chair
medical device manufacturer, ergolet aps, has issued an urgent field safety notice concerning ergolet hera ii with model numbers 041-00250, 041-00255, 041-00256, 041-00280, 041-00281 and serial numbers 1379 to 2180.
after an incident and several claims regarding broken gas springs on the hera ii, ergolet has conducted a risk analysis and decided that replacement of the gas spring is necessary. according to ergolet, the back fixture of the gas spring has been known to break after a significant time of use, resulting in the chair to tilt backwards. if a patient is seated in the chair during this malfunction, head or neck injury may be resulted due to the sudden backwards movement.
the gas spring has been updated with a reinforced back fixture on products with serial number 2181 and higher. the updated gas spring is compatible to all hera ii and is now available for replacement.
according to the manufacturer, the affected devices have been distributed in hong kong. 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: sooil dana diabecare r insulin pump
the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning dana diabecare r insulin pump, manufactured by sooil development.
an update of instructions for use and software controlling minimal basal rate is required in existing/ in-use dana diabecare r insulin pumps having serial numbers beginning ajj, ak, al, and am manufactured after 20 sep 2009.
the manufacturer advises that this pump model is unsuitable for delivery of minimal basal rates below 0.04u/h.
the manufacturer advises affected users to take the following actions:-
users should return the affected devices to the distributors for modification. in the immediate term, users who absolutely require a minimal basal rate of less than 0.04u/h, and whose pumps are so set, should seek an alternative model capable of the rate required and discontinue use of the dana diabecare r model in use as soon as possible, at the same time notifying the manufacturer or the distributor.
users with pumps set through “doctor mode” to deliver 0.01u/h should reset them through the same means to deliver a minimal basal rate of not less than 0.04u/h, and notify the manufacturer or the distributor.
distributors will contact every pump user to deliver revised ifu and with a view to upgrading the pump software to prevent setting of basal rates below 0.04u/h. pumps whose current software prevents use at minimal basal rate settings below 0.1 u/h (the default value) may be upgraded to provide a minimal basal rate of 0.04u/h only of the user so requires.
according to the manufacturer, the affected devices were not distributed in hong kong.
for details, please refer to mhra website
http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/
fieldsafetynotices/con231539
if you are in possession of the affected product, please contact your supplier for necessary actions.
posted on 14 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: draeger reusable latex breathing bags
medical device manufacturer, draeger, has issued a field safety notice concerning its reusable latex breathing bags with part numbers 2165686, 2165953, 2165694, 2165708, 2165716, 2165724, 2165763, 2165775 and 2165783,as part of test lung with part number 8403201, and as part of reusable anaesthesia sets with part numbers m33681, m27542, m34822, m34823 and m34824.
the manufacturer became aware of an incident where a user suffered an acute allergic reaction after using a drager latex test lung. during investigation of this incident, the manufacturer discovered that the breathing bag that belongs to the test lung and other latex breathing bags are labelled nr, which is the abbreviation for natural rubber (latex). however, the labelling does not comply with the applicable international standards for medical devices.
drager breathing bags made of latex (blue) are distinguishable from the latex-free version made of silicone (transparent) by their colour. the test lung with part number 8403201 and the breathing bags in the reusable anaesthesia sets with part numbers m33681 and m27542 have been switched to the latex-free version made of silicone.
the manufacturer reminds users that the blue reusable breathing bags bearing the marking “nr’ do contain natural rubber (latex) and latex products can cause allergic reactions. furthermore, the manufacturer is currently working on improved labelling on the products.
according to the local supplier, the affected products were distributed in hong kong.
if you are in possession of the products, please contact your supplier for necessary actions.
posted on 11 march 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: draeger ondal ac2000 spring-loaded arm
the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning ondal ac2000 spring-loaded arm, manufactured by draeger and up until the end of 2006. the affected part numbers are g19051, g19262, g93358 and g93359.
the manufacturer has received case reports where a welded seam in the spring-loaded arm of the monitor holder broke. investigations revealed that the welded seam in the spring-loaded arm was unable in isolated cases to withstand the dynamic stress over years where monitors were frequently moved. the monitor is then at risk of falling. although no injury was reported, the risk of injury to persons positioned beneath the monitor cannot be excluded.
the manufacturer advises users that monitors in the affected installations must not be positioned above people and that monitors must be moved with care (e.G. holding monitor in both hands) until the replacement has been carried out. in particular, monitors should not be positioned with considerable force – the stress on the lower joint of the spring-loaded arm should be minimized. the manufacturer would arrange replacement of the affected spring-loaded arm.
for details, please refer to the following link:http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con394667
if you are in possession of the affected product, please contact your supplier for necessary actions.
posted on 01 april 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: draeger medical infinity acute care system monitoring solution using with dualhemo mcable
medical device manufacturer, draeger medical, has issued a medical device safety alert regarding infinity acute care system (iacs) with dualhemo mcable.
the manufacturer was informed that the displayed value for the invasive blood pressure measurement of the iacs was lower than the actual patient values were. in one of the cases the user started an incorrect patient therapy because of the indicated too low pressure. no patient injury has been reported in relation to these four cases.
investigations on this topic have shown that liquid ingress in the cable connection of the dualhemo mcable may cause inaccurate measurements. further investigation revealed that this can happen if the dualhemo mcable is used in a non-vertical position or vertically but top down instead of top up, or if it is simply laid down on the floor or on the patient bed and is not adequately positioned.
the instructions for use (ifu) of the iacs does identify that the dualhemo mcable should be positioned in a vertical orientation. however, it does not describe what is meant by the term vertical. vertical is intended to mean that the dualhemo should be hung on a pole with the two mcables pointed toward the floor. the dualhemo contains an integrated clip on the single cable that is intended to facilitate proper placement and orientation of the dualhemo pod.
the manufacturer has developed an amendment for the ifu describing the correct handling of the dualhemo mcable supported by graphics. draeger advises all affected users to add the amendment to their ifu.
according to the local supplier, the affected products were distributed in hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 29 november 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: draeger oxylog transport ventilators
the australia therapeutic goods administration (tga) posted a medical device safety alert concerning oxylog transport ventilators manufactured by draeger medical. the affected model numbers are oxylog 3000plus and oxylog 2000plus, and the affected serial numbers are asej-0138 and asek-0011.
the manufacturer has received reports of devices displaying the error message “poti unplugged”. the investigation has revealed that a limited batch of faulty control panel pcbs - onto which the potentiometer for setting the ventilation parameters is soldered. this can result in the contact to the respective potentiometer being interrupted. the device then discontinues ventilation, gives an audible alarm and displays the error message poti unplugged.
the manufacturer advises users that if this error occurs they must immediately commence ventilation using an independent ventilator (manual ventilation bag) as specified in the instructions for use manual. furthermore, the manufacturer will be contacting all affected users to organise the correction of the affected devices.
according to the local supplier, the affected products were not distributed in hong kong.
for details, please refer to the following link:http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2014-rn-00168-1
if you are in possession of the affected product, please contact your supplier for necessary actions.
posted on 20 february 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: draeger v series ventilators
the australia therapeutic goods administration (tga) posted a medical device safety alert concerning ps500 external power supply unit used with draeger v series ventilators manufactured by draeger medical. the affected model numbers are infinity v500, babylog vn500 and evita v300.
the manufacturer has become aware about events in which the battery capacity of the optional ps500 of the infinity acs workstation critical care (evita infinity v500) did not last as long as expected. the batteries installed in the ps500 deplete much earlier than expected although the battery indicator showed a sufficiently charged battery. in some cases neither the “battery low” nor the “battery depleted” alarm was given, when the remaining battery capacity fell below 10%. available data indicates that the charged battery will last for at least 3 minutes. in case of a main power loss, this 3 minute battery back-up should typically be sufficient until the emergency main power supply is re-established.
the manufacturer is advising users to only use the affected device for transport if absolutely necessary and users should not rely on the battery status indicator. users are recommended to have a breathing bag available for manual ventilation as per the instructions for use.The manufacturer is also advising that if the power fail alarm occurs during transport, users should provide manual ventilation and immediately connect the ventilator to wall power to resume ventilation. batteries on all affected devices will be replaced by the manufacturer as an interim correction, until a permanent fix can be developed.
according to the local supplier, the affected products were not distributed in hong kong.
for details, please refer to the following link:http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2014-rn-00165-1
if you are in possession of the affected product, please contact your supplier for necessary actions.
posted on 20 february 2014.