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External Defibrillators May be Defective, FDA Says

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As many as 280,000 external defibrillators that contain components made by Cardiac Science Corp. of Bothell, Wash may be defective, the Food & Drug Administration (FDA) warned today. The FDA warning applies to 14 models of defibrillators, including:

• Powerheart models 9300A, 9300C, 9300D, 9300E, 9300P, 9390A and 9390E
• CardioVive models 92531, 92532 and 92533
• Nihon Kohden models 9200G and 9231
• GE Responder models 2019198 and 2023440

Cardiac Science recalled its Powerheart and CardioVive models, manufactured between August 2003 and August 2009, on Nov. 13, 2009. But the FDA has since learned that additional Cardiac Science models, two marketed under the Nihon Kohden name, and two marketed by GE Healthcare as GE Responder have similar problems.

According to the FDA’s warning, Cardiac Science issued a software update for two of its Powerheart defibrillators in February 2010 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.

The FDA recommends that hospitals, nursing homes and other high-risk settings obtain alternative external defibrillators and arrange for the repair or replacement of the affected defibrillators.

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