FDA Warning: Several Cardiac Science Defibrillator Models May Fail to Properly Deliver Shocks 

On April 27, 2010, the U.S. Food and Drug Administration (FDA) issued a warning that approximately 280,000 external defibrillators used worldwide in health care facilities, public places, or in the home may malfunction during attemtps to rescue people in sudden cardiac arrest. Faulty components in defibrillators manufactured by Cardiac Science Corporation may cause the devices to 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 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.

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, the 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 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. 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.

**Update - April 29, 2010 - The U.S. Food and Drug Administration has updated users that Nihon Kohden (NK) and GE Responder models are also affected although they were not identified in earlier communications about this recall. In addition, Cardiac Science issued a software upgrade for the devices’ self tests on February 24, 2010 for the Powerheart automatic external defibrillators (Models 9390A and 9390E) and is planning on issuing a similar software upgrade for other affected devices. However, FDA’s review of the updated software indicates that it detects some but not all electrical component defects.

Read the FDA notice for more information.