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Software Problems with Defibtech Lifeline and ReviveR External Defibrillators
Posted on April 29, 2008
The device company Defibtech is recalling two models of semi-automatic external defibrillators because the self-test software in these devices may clear a defibrillator that has a low battery condition. If that happens, the device may be unable to deliver a shock and resuscitate a patient.
The action affects over 40,000 Lifeline and ReviveR AEDs with software versions 2.002 and earlier. These devices have been distributed to schools, fire and emergency medical services, businesses and health clubs.
Defibtech is notifying its distributors and customers about the software problem and the company is working on a new version of the software to fix it. When it is ready, this new software will be sent to customers free of charge.
In the meantime, the company says that these devices can still be used if customers follow specific maintenance instructions for verifying that the defibrillator will function. To identify which version of software a device is using, contact Defibtech at 1-877-453-4507.
Additional Information:
FDA MedWatch Safety Alert. Defibtech Lifeline and ReviveR Automated External Defibrillators (AEDs). March 7, 2007.
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Lifeline
Defibtech, LLC. Corrective Action and Software Upgrade Information.
http://www.defibtech.com/fa2007/
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