FDA Issues Warning for 14 Faulty External Defibrillators

Washington, DC: 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, the U.S. Food and Drug Administration warned today.

Sudden cardiac arrest is a condition in which the heart suddenly and unexpectedly stops beating. When this happens, blood stops flowing to the brain and other vital organs, leading to death if not treated within minutes.

External defibrillators can send an electric shock to the heart to try to restore normal heart rhythm when sudden cardiac arrest occurs.

Faulty components in defibrillators manufactured by Cardiac Science Corp. of Bothell, WA, 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 (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.

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.

APR-27-10: FDA Warns Users about Faulty Components in 14 External Defibrillator Models [FDA: NEWS RELEASE]

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Published on Apr-27-10