April 27, 2010 / 7:31 PM / 9 years ago

FDA warns on Cardiac Science devices

WASHINGTON (Reuters) - U.S. health regulators warned on Tuesday about faulty components in more than a dozen types of external defibrillators made by Cardiac Science Corp.

The agency cited 14 models made by Cardiac Science, some of which are sold by other companies such as General Electric Co’s GE Healthcare unit.

About 280,000 external defibrillators used worldwide to try to rescue people having heart attacks could malfunction, the agency said.

A spokesman for Cardiac Science had no comment.

The FDA said Cardiac Science had already recalled some models, but that other models marketed under GE and Nihon Kohden brands have similar problems. A Cardiac Science software update issued for some models detects some, but not all defects, it added, noting that similar software upgrades are planned for other models.

While users usually check to ensure the device’s green light shows it “is rescue-ready,” that does not mean a faulty device is working and could “give a false sense that they are in proper working order,” the FDA said.

Hospitals, nursing homes and others should use alternative defibrillators, the agency said.

Defibrillators are a key business for the heart device and technology company, and the widespread problems are likely to cost it millions.

Already in 2009, Cardiac Science said it took a $2.5 million voluntary recall charge in the fourth quarter and recorded a charge of $18.5 million for the software update.

GE Healthcare, which distributes Cardiac Science defibrillators under the GE Responder brand, said in a statement that it is working with Cardiac Science to address the concerns cited by the FDA.

Reporting by Susan Heavey; editing by Andre Grenon and Matthew Lewis

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