Federal officials issue warning on faulty defibrillators

Fourteen models of external defibrillators, devices used in homes, hospitals, stadiums and other venues to rescue people from sudden cardiac arrest, have faulty components and may fail to deliver a lifesaving electrical jolt, federal regulators warned Tuesday.

An estimated 280,000 of the defective defibrillators have been distributed worldwide.

External defibrillators are designed to send an electric shock to the heart in an effort to restore normal heart rhythm. A spot check of several major external defibrillator users on Long Island Tuesday, including the Nassau and Suffolk police departments, revealed the use of brands other than those cited as defective.

Consumers, however, are being advised to check their brand and model numbers to be certain they do not have a faulty device. Hospitals, nursing homes and others should use alternative defibrillators, the agency said.

External defibrillators are becoming increasingly common fixtures in homes and public places and can save a person from sudden cardiac arrest - when the device works.

Their widespread use in public venues across the state largely occurred through the advocacy of the Louis Acompora Foundation in Northport, established in 2000 after a 14-year-old lacrosse player died of cardiac arrest.

"The FDA is issuing this notice so that users can take the proper steps necessary to assure they have access to safe and effective defibrillators," Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said in a statement Tuesday.

The U.S. Food and Drug Administration said the 14 models are made by four companies: Powerheart, which has seven affected models; CardioVive, which has three, and Nihon Kohden and GE Responder, which each have two.

All of the brands contain components manufactured by Cardiac Science Corp. of Bothell, Wash., that may interfere with the machines' capacity to deliver a shock. An additional problem caused by faulty components includes interference or background noise that makes the device unable to accurately analyze heart rhythm.

A spokesman for Cardiac Science had no comment.

The FDA said Cardiac Science had already recalled some models. It advises all owners of potentially defective external defibrillators to arrange for their repair or replacement.

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

Federal officials cited the following defibrillator models as those having problems:

Powerheart: 9300A, 9300C, 9300D, 9300E, 9300P, 9390A and 9390E

CardioVive: 92531, 92532 and 92533

Nohon Kohden: 9200G and 9231

GE Responder: 2019198 and 2023440

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.

BAILIS: and also:

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.

With Reuters