FDA Warns About External Defibrillator Models With Faulty Components

FDA has warned that about 280,000 external defibrillators used worldwide in health care facilities, public places, or in the home may malfunction during attempts to rescue people in sudden cardiac arrest. External defibrillators can send an electric shock to the heart to try to restore normal heart rhythm when sudden cardiac arrest occurs.

FDA said that the faulty components in defibrillators manufactured by Cardiac Science Corp of Bothell, Washington, may cause the devices fail to properly deliver a shock. In addition to failure to deliver needed shocks, other problems with the affected models may include interruption of electrocardiography (ECG) analysis, failure to recognize electrode pads, and interference or background noise that makes the device unable to accurately analyze heart rhythm.

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.

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.

Reportedly, for all other users, including those who use the device at home or as part of public access programs, the FDA recommends using alternative external defibrillators if they are available, and arranging for the repair or replacement of the affected models.

If alternative external defibrillators are not immediately available, then FDA recommends continuing to use the affected devices if needed, because they may still deliver necessary therapy. The potential benefits of using the available external defibrillators outweigh the risk of not using any of the affected external defibrillators or the risk of device failure.

Cardiac Science had recalled its Powerheart and CardioVive models, manufactured between August 2003 and August 2009, on November 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.

Cardiac Science had 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, FDA’s review of the updated software indicates that the software detects some, but not all, identified defects.

Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said: “The FDA is issuing this notice so that users can take the proper steps necessary to assure they have access to safe and effective defibrillators.”