FDA Warns On GE, Cardiac Sciences External Heart Defibrillators

The Food and Drug Administration warned of additional problems with external heart defibrillators made by Cardiac Science Corp. (CSCX) and GE Healthcare (GE).

Such external defibrillators are used worldwide in health care facilities, public places or in the home. However, the FDA said 14 models of defibrillators may malfunction during attempts to rescue people in sudden cardiac arrest, a condition in which the heart stops beating.

The FDA said faulty components in some of Cardiac Science Corp.'s defibrillators may cause the devices to fail to properly deliver a shock. Other problems 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 FDA said.

Two models of Cardiac Sciences devices--the Powerheart and CardioVive --were recalled last November. The recall affected devices manufactured between August 2003 and August 2009.

However, the FDA said two additional Cardiac Science models, marketed under the Nihon Kohden name, and two GE Responder models have similar problems.

The agency said Cardiac Science Corp. has issued a software update for two of its Powerheart defibrillators and plans to issue similar software updates for other affected devices.

But, the FDA said it reviewed the software update and found that it "detects some, but not all, identified defects."

Representatives from GE Healthcare and Cardiac Science weren't immediately available for comment.

-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; [e-mail]