Defibrillator Failures Linked to 370 Deaths

A new analysis suggests that flaws in some automated external defibrillators may be linked to 370 deaths.

The growing presence of AEDs in public places such as malls, airports, even some churches, has offered assurances that life-saving technology can prevent sudden cardiac death by delivering an electric shock to the heart.

The devices, usually packed in a bright yellow casing with bold lettering, can "talk" a Good Samaritan through cardiac rescue with built-in voice commands.

But in an examination of Food and Drug Administration advisories spanning a decade, Boston medical investigators found that 1 in 5 AEDs was recalled because of their potential to malfunction and that more than 300 people probably died because devices failed.

The examination of FDA data between January 1996, and December 2005, is the first comprehensive study of AED safety issues, and highlights the need for owners of the devices to keep pace with FDA advisories.

"We reviewed all AED adverse reports submitted to the FDA and identified cases where AEDs malfunctioned during an attempted resuscitation," said Dr. William Maisel, director of the pacemaker and defibrillator service at Beth Israel Deaconness Medical Center in Boston.

Maisel, also an assistant professor of medicine at Harvard Medical School, said though his findings seem alarming, AEDs remain vital to public health.

"These devices have saved the lives of many, many people who otherwise would have died," he said in an interview yesterday. Results of his study are reported in today's edition of the Journal of the American Medical Association.

The American Heart Association estimates 900 people die daily from sudden cardiac arrest. Advocates fought for prominent placement of defibrillators in public venues because studies showed cardiac arrest often occurs in places without medical personnel.

When an AED's soft, round pads are placed on a victim's chest, the machine can, within seconds, determine if the heart is in the rhythm disturbance called fibrillation, a chaotic quivering in which oxygen does not flow to the brain. Death can occur within minutes unless the heartbeat is normalized. While specialized knowledge is not required to operate an AED, the National Heart, Lung, and Blood Institute has sponsored the training of laypeople nationwide, including Long Island.

Maisel said some device owners fail to return registration cards to the maker. When that happens, the manufacturer has no way of notifying owners of a malfunction.

Rob Clark, spokesman for Medtronic Inc., a leading AED manufacturer, said the company promptly notifies registered owners about recalls, usually through certified letters, visits and follow-up phone calls. Recall notices are posted on the company's Web site, he said.

Most newer devices, Clark added, have lights or alarms to signal malfunctions.

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