FDA issues warning about 14 external defibrillator models

About 280,000 external defibrillators used in health care facilities, public places and homes worldwide may malfunction, the Food and Drug Administration (FDA) warned in April. Faulty components in defibrillators made by Cardiac Science Corp. may cause the devices to fail to properly deliver a shock, in addition to other problems. The FDA recommends that hospitals and other high-risk settings obtain alternative defibrillators and arrange for the repair or replacement of the affected 14 defibrillator models. Cardiac Science issued a software update for two of the models in February and plans to issue similar software updates for other affected devices. However, the FDA's review of the updated software indicates that the software detects some, but not all, identified defects.

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