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FDA: Certain Automated External Defibrillators Found Faulty

FDA: Certain Automated External Defibrillators Found Faulty

Agency issues recommendations to owners of several Philips Healthcare HeartStart devices

THURSDAY, Dec. 5, 2013 (HealthDay News) -- All owners of Philips HeartStart automated external defibrillator (AED) devices are advised to contact the company to ascertain whether their device is among those that might be unable to deliver the defibrillator shock needed in a cardiac emergency, according to a Dec. 3 safety alert issued by the U.S. Food and Drug Administration.

The devices, which were manufactured and distributed between 2005 and 2012, go by HeartStart FRx, HeartStart HS1 Home, and HeartStart HS1 OnSite. A recall initiated in September 2012 affected about 700,000 of these devices.

The FDA recommends that owners keep recalled devices until they are replaced. Philips HeartStart AEDs should make a triple chirp sound and display a flashing "i-button" if there is a problem that could prevent the equipment from performing as needed. Technical support is available from 7 a.m. through 5 p.m. (Pacific Standard Time) at 1-800-263-3342, option 5.

"Despite current manufacturing and performance problems, the FDA considers the benefits of attempting to use an AED in a cardiac arrest emergency greater than the risk of not attempting to use the defibrillator," Steve Silverman, director of the Office of Compliance in the FDA's Center for Devices and Radiological Health, said in a statement.

Safety Alert (http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm377446.htm )Press Release (http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm377433.htm )