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: dräger babytherm infant warmers
medicines and healthcare products regulatory agency (mhra), united kingdom, has issued a medical device safety alert concerning babytherm infant warmers [model no.: 8000wb, 8004 and 8010], manufactured by dräger medical gmbh.
the manufacturer became aware of a case in which a side panel on a babytherm 8010 did not fully slide to the bottom in the corner guides and was not completely locked. the side panel did not open during this incident and no patient was affected. when reviewing the locking mechanism in a number of hospitals, it was possible to fully close the side panels by pushing down on them slightly. however, it cannot be guaranteed that the panel will lock in to position under its own weight.
affected users should contact the manufacturer, if they have found that the locking mechanism is not functioning. the manufacturer is advising affected users to pay attention to the information provided in the instructions for use (ifu): “check that the side panels lock securely into position and that they remain securely locked”
for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con448384
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 2 sep 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
Field safety notice: dräger dual hemo mcable pod used with the infinity acute care system (iacs) monitoring solution
medical device manufacturer, dräger medical systems, inc., has issued a safety alert concerning its dual hemo mcable pod used with the infinity acute care system (iacs) monitoring solution.
the manufacturer has determined through internal testing that dual hemo mcable pods with revision index (ri) 15 and 16, which are used with the dräger infinity acute care system, may permit liquid ingress inconsistent with their ipx4 rating, which could potentially result in an incorrect measured value of invasive blood pressure.
the manufacturer has not received any complaints and is not aware of any negative patient consequences arising from this issue. revisions prior to ri 15, with proper orientation will still maintain its designated ipx1 rating and are not within the scope of this safety notice. in addition, revisions labelled ri 17 and greater are not affected by this notice because these revisions continue to meet the ipx4 standard.
affected users are requested to take the following actions:
contact the manufacturer to receive a sleeve that can be applied to protect against liquid ingress
see the safety notice provided by the manufacturer for required upright orientation of the dual hemo mcable pod and installation instructions for the sleeve.
according to the local supplier, the affected product is distributed in hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 3 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: dräger fabius anaesthesia machine
therapeutic goods administration (tga), australia, has issued a medical device safety alert concerning dräger fabius anaesthesia machine manufactured by drägerwerk ag & co kgaa .The affected products are identified as follows:
device: fabius plus xl, fabius tiro, fabius gs premium and fabius plus xl.
serial number: askm-0047, askh-0027, askh-0168, askh-0140 and askm-0246.
the manufacturer has become aware of one case where the automatic ventilation failed during the operation of a fabius unit. this was due to the motor moving beyond the upper position and thereby damaging the ventilator cover. ventilation of the patient could reportedly be continued by means of the manspont mode and a manual resuscitator.
according to the manufacturer, no serious injury has been reported to date. as a precaution the manufacturer will be updating relevant units.
the manufacturer is advising they are currently producing replacement motors for the potentially affected devices. in the interim, the affected users may continue to operate the anaesthesia device with the usual attention and make sure that a manual resuscitator for emergency ventilation is kept ready according to the instructions for use.
for details, please refer to the following tga website:
https://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2018-rn-00158-1
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 1 mar 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: draeger infinity acute care system in neonatal mode
medical device manufacturer, draeger medical gmbh has issued a medical device safety alert concerning infinity acute care system (iacs) in neonatal mode using software versions vg2.0.3 and higher.
it was found in a laboratory test that when a low spo2 (yellow) medium grade alarm was provoked and then paused by the user by using the alarm pause function, the device did not generate the spo2 (red) high grade life threatening spo2 low alarm on the cockpit or central station when the spo2 value was further decreased to reach the set alarm limit for the high grade life threatening spo2 alarm.
the correct spo2 value was indicated on all devices and the manufacturer is not aware of any incidents during use on patient. draeger is developing a software upgrade to fix the defect. meanwhile, draeger advises the users not to pause the yellow spo2 low alarm without adequate patient monitoring.
according to the local supplier, the affected products were distributed to hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 6 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: draeger oxylog transport ventilators
medical device manufacturer, draeger medical gmbh, has issued a medical device safety alert concerning its oxylog 3000 and oxylog 3000plus.
in december 2015 the manufacturer informed customers about an error condition observed in the market with products of the oxylog 3000 family, where the loss of contact of one of the control knobs generates an error message (previously referred to as “poti unplugged”). in these cases, acoustical and visual alarms are triggered, the breathing system releases pressure and the ventilation function stops operating. personal injury was not reported in any of these situations.
the manufacturer’s investigations indicate that the error condition is caused by an oxide layer in the potentiometer. these oxide layers may accumulate over a longer period of time if various factor collude i.E. if the knobs are moved rarely or never. a verified remedy is repeated twisting of the knobs that removes the oxide layer.
however, this particular error condition was still reported from the field after the safety notice. the remedy of twisting the knob is still considered effective. nonetheless, to reduce the impact of this special error condition the manufacturer has developed a new software that reduces the impact of the error condition.
software version 1.06 will now be introduced for oxylog 3000pius, version 1.23 for oxylog 3000, respectively. the manufacturer will contact customers to schedule a time to perform the software update.
according to the manufacturer, whenever a “control knob faulty” condition will occur with a device being equipped with the new software the device will continue to ventilate with the last valid settings, display for example the values for tidal volume in case of a defective potentiometer for vt and post the corresponding alarm. as reflected in the amended instruction for users, the customers are advised to check patient’s condition and the ventilation.
according to the local supplier, the affected products are distributed in hong kong.
if you are in possession of the affected product, please contact your supplier for necessary actions.
posted on 12 december 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: heartsine samaritan pad 500p automated external defibrillators
the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning samaritan pad 500p automated external defibrillators, manufactured by heartsine technologies, inc. the affected serial numbers ranged from 10b0010001 to 14b00461703, manufactured between february 2010 and january 2014.
according to the manufacturer, the software in the concerned defibrillators may miscalculate the cpr rate of compression per minute being administered to the patient. the rescuer may, therefore, be incorrectly advised by the device to “push slower” when, in fact, the cpr rate is at an acceptable level.
to address the issue, the manufacturer has posted an updated version of the software for the samaritan pad 500p on the heartsine technologies website for download.
for details, please refer to the following link:http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con382708
if you are in possession of the affected product, please contact your supplier for necessary actions.
posted on 04 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: heartsine samaritan pad 300/pad 300p automated external defibrillator
the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning samaritan pad 300/pad 300p automated external defibrillator manufactured by heartsine technologies ltd.
the manufacturer has initiated a voluntary correction regarding the following two issues that could affect ability of the device to deliver therapy to a patient in a sudden cardiac arrest event, if needed:
issue 1 (on/off issue): the device may turn itself on without input from the user. when this occurs, the normal sequence of audible prompts will be emitted from the device. if the device does not detect that the audible prompts are followed (e.G., that a patient is connected to the electrodes to allow the device to read the patients’ ecg and start the normal sequence of events), the device will automatically switch off after 10 minutes to save power.
this sequence of events can happen repeatedly or intermittently. if this condition continues undetected, the battery will eventually become completely depleted. in worst-case situations the battery could, within a week, be depleted below the minimum battery capacity necessary to allow for the delivery of therapy. in such circumstances, the device will subsequently be capable of delivering therapy if an adequate power supply is provided. devices potentially affected by the on/off issue were manufactured between august 2004 and december 2010 and have a warranted life of up to 7 years.
issue 2 (battery management software issue): certain pad 300/pad 300p devices containing early versions of the battery management software may misinterpret a temporary drop in battery voltage as signaling a low battery. the issue will result in the device prematurely displaying the low battery warning and turning itself off even though sufficient battery capacity remains. this may occur when the device performs its weekly self-test, or when the device is turned on, or when the device is preparing to deliver a shock, or after delivering a shock. if the low battery warning is triggered due to this issue, the device will have sufficient power to deliver multiple shocks but it is possible that the device will only deliver one shock before turning itself off. if this occurs, delivery of any subsequent shocks may be delayed and would likely only be delivered at the lowest energy level of 150 joules. once the device has experienced this condition, it is more likely to experience it again.
this condition can occur where the installed pad-pak has already been partially depleted due to normal battery depletion or where the installed pad-pak is an 800 mah capacity battery. this software version was distributed until end december 2010. devices containing software version 1.4.2 / 3.2.0 or higher are not susceptible to this issue.
no other heartsine technologies ltd. automated external defibrillator products are affected by either issue addressed in this letter.
for issue 1, the manufacturer will provide users a reserve 1500 mah pad-pak battery which is to be held in reserve in the zippered pouch on the back of the carry case of the device. for issue 2, the manufacturer will provide users a data cable that will allow them to download the current version of the device's battery management software (http://www.Heartsine.Com/recall/software_updates). in addition, a hang tag is provided with the field safety notice to provide instruction for users on how to install the reserve pad-pak battery should the existing battery appear to lack sufficient battery power during a patient event and the hang tag will also be provided to users with the reserve battery inside the upgrade kit.
according to the distributor, the affected devices were not distributed in hong kong.
for details, please refer to the following mhra website:
http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con184701
if you are in possession of the product, please contact your supplier for necessary actions.
posted on 19 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
Medical Device Safety Alert
Causa
Medical device safety alert: heartsine samaritan pdu 400
the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning samaritan pdu 400, manufactured by heartsine technologies ltd. the affected serial numbers are from 08p00001003 to 11p00007347.
the software of samaritan pdu 400 device may fail to accurately determine the remaining capacity of the device battery. rather than emitting an alarm warning users that the device has insufficient battery to deliver therapy, the device may simply shut down. the affected device may be unable to operate during a sudden cardiac arrest. the manufacturer will arrange replacement of the affected pdu 400 devices for users.
according to the regional distributor in singapore, the affected products were not distributed in hong kong.
for details, please refer to mhra website:
http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con321967
if you are in possession of the product, please contact your supplier for necessary actions.
posted on 16 october 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: jolife ab lucas 2 chest compression system
the therapeutic goods administration (tga) of australia has issued a medical device safety alert concerning lucas 2 chest compression system [item number: 3302430-145; multiple affected serial numbers; manufactured between september 2014 and april 2015], manufactured by jolife ab.
the manufacturer has become aware of a potential reliability issue where the lucas device may not respond to the push of certain buttons due to potential damage of an internal cable. the user control panel cable can be damaged by rubbing against an adjacent cable connector.
if the malfunction were to occur, it may cause the device to exhibit one of the following:
the device does not change from one active mode to the other
the device does not begin compressions
the device does not temporarily stop and lock in the start position when the pause button is pressed
the manufacturer will arrange for replacement of an internal cable. users are advised to refer to sections 3.8 and 5.4 of the instruction for use, which states that if there are interruptions, if the compressions are not sufficient, or something unusual occurs during operation: push on/off for 1 second to stop lucas and remove the device from the patient. immediately start manual chest compressions.
for details, please refer to the tga’s website:
http://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2018-rn-00147-1
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: novadaq technologies inc. spy-phi drape
medical device manufacturer, novadaq technologies inc., has issued a medical device safety alert concerning its spy-phi drape. the affected model numbers are hh2000 and hh2020.
according to the manufacturer, a pinhole through the drape material was identified following use of a drape in a surgical procedure. while there have been no reports of infection submitted to the manufacturer as a result of the drape material integrity being compromised, a remote possibility exists that a compromised drape may cause harm to a patient through infection.
product recall is on-going.
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 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: physio-control lifepak 1000 defibrillator
the united states food and drug administration (fda) has issued a medical device safety alert concerning lifepak 1000 defibrillator [affected battery part number: 320371500xxx], manufactured by physio-control, inc.
the manufacturer has become aware of incidents where customers have attempted to use their lifepak 1000 defibrillator and the device has shut down unexpectedly due to a very low battery. a defibrillator in this scenario has the potential to fail to deliver a shock, with the potential result that therapy is not delivered and a patient is not resuscitated. a software malfunction in the lifepak 1000 defibrillator causes the readiness display panel to incorrectly indicate a low battery charge when the battery is actually in a very low charged state and in need of replacing.
the manufacturer advises users that
batteries at both low battery charge and very low battery charge must be replaced with a fully charged battery, whether or not the "ok" symbol is present.
users should always carry a spare fully-charged battery, as stated in the operating instructions.
the manufacturer continues to investigate this issue and will have a follow up communication with users regarding this issue. this communication may include updates to operating instructions, software updates or additional maintenance instructions.
according to the local supplier, the affected products were distributed in hong kong.
for details, please refer to the following fda website:
http://www.Accessdata.Fda.Gov/scripts/enforcement/enforce_rpt-product-tabs.Cfm?action=select&recall_number=z-1660-2014&w=06042014&lang=eng
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 06 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: physio-control lifepak 1000 defibrillators
the united states food and drug administration (fda) has posted a medical device safety alert concerning lifepak 1000 defibrillator, manufactured by physio-control.
the manufacturer announced that they are launching a voluntary field action for the lifepak 1000 defibrillator due to reported instances where the device has shut down unexpectedly during patient treatment. the manufacturer has received 34 reports where customers have attempted to use their lifepak 1000 defibrillator and the device has shut down unexpectedly due to an intermittent connection between the battery and device electrical contacts. a defibrillator in this scenario may not be able to deliver therapy during a resuscitation attempt, which may expose patients to the risk of serious harm or death. the manufacturer is aware of 8 adverse events related to this issue.
the manufacturer has determined that this intermittent connection is a result of wear and subsequent oxidation formation between the battery and device electrical contacts. this condition can occur over time in lifepak 1000 devices that are exposed to vibration and have a battery installed for long periods of time. this issue can potentially affect any lifepak 1000 device, however customers with non-rechargeable batteries who do not routinely remove the battery for inspection, as indicated in the lifepak 1000 defibrillator operating instructions, are more susceptible to this issue.
the manufacturer is contacting customers and advising them to immediately remove and reinstall the battery from their device(s). customers are also being advised to implement a weekly schedule of battery removal and reinstallation for all lifepak 1000 devices. the removal and reinstallation of the battery will clean the contacts of oxidation and will reduce the likelihood of this issue from occurring. the manufacturer will be initiating a hardware device correction for all affected lifepak 1000 devices and they will contact customers to schedule device corrections once the hardware correction is ready for implementation.
for details, please refer to the fda websites:
http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm537116.Htm
http://www.Fda.Gov/safety/recalls/ucm537114.Htm
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 16 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
Press release
Causa
safety alert on automated external defibrillator lifepak 1000
safety alert on automated external defibrillator lifepak 1000
the department of health (dh) today (january 20) drew the public's attention to a safety alert concerning the lifepak 1000 defibrillator manufactured by physio-control as this automated external defibrillator would reportedly shut down unexpectedly during patient treatment.
the dh, through its routine surveillance on medical device safety alerts, noticed the above alert issued by the food and drug administration of the united states.
according to the alert, the manufacturer has received 34 reports that the device has shut down unexpectedly during patient treatment due to an intermittent connection between the battery and device electrical contacts.
according to the manufacturer, this intermittent connection is a result of wear and subsequent oxidation formation between the battery and device electrical contacts. this condition can occur over time in lifepak 1000 devices that are exposed to vibration and have a battery installed for a long period of time.
the alert has indicated that a defibrillator in this scenario may not be able to deliver therapy during a resuscitation attempt, which may expose patients to the risk of serious harm or death. the manufacturer is aware of eight adverse events related to this issue.
this issue can potentially affect any lifepak 1000 device. however customers with non-rechargeable batteries who do not routinely remove the battery for inspection, as indicated in the lifepak 1000 defibrillator operating instructions, are more susceptible.
the dh's enquiries with the manufacturer’s branch office in singapore revealed that 653 units of the potentially-affected device had been distributed in hong kong, including local distributors, medical organisations, estate management agencies, recreational clubs, schools and other venues.
"so far, the dh has not received any reports of adverse incidents related to the affected device in hong kong," a spokesman for the dh said.
"the dh has also informed public and private hospitals and relevant medical associations about the alert and will continue to liaise with the manufacturer on the follow-up actions," the spokesman said.
members of the public who are in possession of the affected device are advised to immediately remove and reinstall the battery from their devices and to implement a weekly schedule of battery removal and reinstallation for all lifepak 1000 devices. this action will clean the contacts of oxidation and will prevent the issue from occurring.
according to the manufacturer, if the device powers off unexpectedly, either during inspection or during patient treatment, the battery should be immediately removed and reinstalled to restore power to the device. if the power is not restored, replace the battery with a spare battery and contact the supplier to arrange for servicing of the device.
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: physio-control lifepak 15 monitor/defibrillator
the united states food and drug administration (fda) has posted a medical device safety alert concerning lifepak 15 monitor/defibrillator, manufactured by physio-control, with manufacturing dates from 3 september 2014 to 30 june 2016 and distribution dates from 13 september 2014 to 4 july 2016.
the manufacturer is recalling the lifepak 15 monitor/defibrillator due to an electrical problem which may prevent the device from delivering the electrical shock needed to revive a patient in cardiac arrest. if the electrical shock is not delivered, the monitor will indicate “abnormal energy delivery” on the display. a delay in delivering this therapy could result in serious patient injury such as permanent organ damage, brain injury, or death.
for details, please refer to the following websites:
http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm540979.Htm
http://www.Physio-control.Com/workarea/downloadasset.Aspx?id=2147498478
according to the local supplier, the affected product is not distributed in hong kong.
if you are in possession of the affected product, please contact your supplier for necessary actions.
posted on 10 february 2017.
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: physio-control, lifepak 20e defibrillator/monitor
medical device manufacturer, physio-control, has issued a medical device safety alert concerning its lifepak 20e defibrillator/monitor [model/catalog numbers: 70507-xxxxxx, 99507-xxxxxx; lot number multiple].
the manufacturer is aware that some devices have had power-related failures as customers prepared their device for initial deployment or during use within the first year of distribution. the symptoms of these failures may include unexpected power on and power off, device lock-up, or a failure to power on or off.
according to the manufacturer, the failures are the result of the manufacturing process residue located beneath a component mounted on the power printed circuit board assembly (pcba). this has the potential to result in a failure to deliver therapy to the patient and serious injury or death. the manufacturer has not received any adverse events reported as a result of this issue.
the manufacturer will contact potential affected users to arrange for a device correction included the replacement of the power pcba. the customers are requested to follow the recommended daily operator’s checklist steps in accordance with lifepak 20e defibrillator/monitor operating instructions – section 7 – maintaining the equipment. if the users experience any of the symptoms described above, contact the manufacturer immediately to arrange servicing to your device.
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 09 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
Press release
Causa
Safety alert on two automated external defibrillators
the department of health (dh) today (march 22) drew the public's attention to a safety alert issued by an american medical device manufacturer, physio-control inc, on the battery performance of two of its automated external defibrillators (aeds), lifepak cr plus and lifepak express.
the dh, through its routine surveillance on medical devices, noticed the above alert from the uk's medicines and healthcare products regulatory agency (mhra).
according to the manufacturer, both aeds operate to deliver therapy by battery power. the battery charger is designed to be replaced approximately every two years. however, in some rare situations, the battery charger might experience early internal battery depletion due to an internal electrical failure, resulting in the battery charger lasting less than two years. devices manufactured from 2005 to 2012 are potentially affected by this issue.
physio-control inc remarked that the probability of such a failure was extremely remote and the display of the aeds would continue to reflect the device and battery status, even if the device is affected by the issue.
"locally, the dh's preliminary enquiries with the local supplier, ids medical systems (hong kong) company limited, revealed that lifepak cr plus has been distributed in hong kong. while the distribution of the potentially affected devices is being confirmed by the supplier, customers are advised to immediately check the readiness of their devices and the battery according to the operating instructions. they should contact their local supplier if a problem is identified.
"so far, the dh has not received any relevant report of adverse incidents related to the aeds in hong kong," the spokesman added.
the dh has informed public and private hospitals and relevant medical associations about the alert and shall continue to liaise with the supplier on the follow-up actions.
ends.
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: physio-control lifepak cr plus and lifepak express automated external defibrillators
the food and drug administration (fda) of the united states posted a medical device safety alert concerning lifepak cr plus and lifepak express automated external defibrillators (aed), manufactured by physio-control inc.
the affected aeds may fail to initiate voice prompts when the on/off button is pressed and the lid is opened due to an internal component (reed switch) that can intermittently become fixed in the closed position.
according to the manufacturer, a defibrillator in this condition will fail to deliver a shock, with the potential result that therapy is not delivered and a patient is not resuscitated.
for details, please refer to the fda enforcement report website:
http://www.Accessdata.Fda.Gov/scripts/ires/index.Cfm (recall number: z-2100-2016)
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 6 july 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: physio-control adult-edge electrode with quik-combo connector and redi-pak preconnect
the medicines and healthcare products regulatory agency (mhra) of united kingdom posted a medical device safety alert concerning adult-edge electrode with quik-combo connector and redi-pak preconnect manufactured by physio-control inc. [catalogue number: 11996-000017; min number: 3202674-005; lot numbers: 516907, 519815, 519816].
the manufacturer conducted a voluntary recall of the abovementioned product due to a low-level potential for damage to the wire insulation during the manufacturing process of these specific lots. the defibrillation electrodes used in conjunction with certain physio-control lifepakr products. the use of products with this condition may result in a potentially increased risk for reduced or no patient therapy, arcing of current, sparking, and patient and/or clinician bum.
the manufacturer advises customers to quarantine the affected products and return them to the manufacturer.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 16 february 2016.