physio-control lifepak 1000 defibrillators 의 안전성 경고

Safety alert

2017-01-16

2017-01-16

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20170116.html

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.