FDA issues warning on 14 faulty debrillator models

About 280,000 external defibrillators used worldwide may malfunction during attempts to rescue people in sudden cardiac arrest, the FDA cautioned Tuesday. Faulty components in defibrillators manufactured by Cardiac Science may cause the devices to fail to properly deliver a shock. Other potential problems that might occur during the use of the defibrillators include interruption of electrocardiography analysis, failure to recognize electrode pads, and interference or background noise that makes the device unable to accurately analyze heart rhythm.

Last November, Cardiac Science recalled its Powerheart and CardioVive models manufactured between August 2003 and August 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. The 14 models, which include automated and semi-automated devices, are:

  • Powerheart models 9300A, 9300C, 9300D, 9300E, 9300P, 9390A and 9390E;

  • CardioVive models 92531, 92532 and 92533

  • Nihon Kohden models 9200G and 9231 and

  • GE Responder models 2019198 and 2023440.

Cardiac Science issued a software update for two of its Powerheart defibrillators in February and plans to issue similar software updates for other affected devices. However, 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 devices. For all other users, including those who use the device at home or as part of public access programs, the agency recommends using alternative external defibrillators if they are available, and arranging for the repair or replacement of the affected models.

- see the FDA's notice

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