Physio-Control is recalling more than 50,000 LIFEPAK 1000 defibrillators used to deliver lifesaving electrical shocks to people during sudden cardiac arrest – a condition in which the heart suddenly and unexpectedly stops beating – because of an electrical issue that may cause the device to shut down unexpectedly during patient treatment. The Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall reserved for products in which use may cause serious injuries or death.
Physio-Control has determined that the power interruptions may be caused by wear and oxidation formation between the battery and device electrical contacts. This may prevent the device from delivering the electrical shock needed to revive a patient during cardiac arrest. A delay in delivery of this therapy could result in serious patient injury such as permanent organ damage, brain injury, or death.
The recall affects 50,046 LIFEPAK 1000 defibrillators with the product part numbers 320371500XX. There are 133,330 affected serial numbers. Customers can check to see if their serial number is included here. Affected units were distributed nationwide between June 30, 2006, and Dec. 23, 2016. The LIFEPAK 1000 defibrillator is intended for use by medical professionals who are trained in CPR.
Health care professionals and customers with affected devices have been contacted by Physio-Control and instructed to immediately remove and reinstall the battery from the LIFEPAK 1000 defibrillator, which will clean the contacts of oxidation and restore power to the device. The company also recommended a weekly schedule of battery removal and reinstallation for all LIFEPAK 1000 devices and advised those with the defibrillators carry a spare, fully charged battery.
Any adverse events related to this recall should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.
Source: FDA Safety Communication