The U.S. Food and Drug Administration (FDA) has put out a warning for 280,000 defibrillators used worldwide in health care facilities, public places, or in the home for malfunctions during attempts to rescue people in sudden cardiac arrest.

Faulty components in defibrillators manufactured by Cardiac Science Corp. of Bothell, Wash., may cause the devices to fail to properly deliver a shock. 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
• 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 ones. For all other users, 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 available, the FDA recommends continuing to use the affected devices because the potential benefits of using the available external defibrillators outweigh the risk of not using any.

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, have similar problems.

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