Portable heart defibrillators prone to recalls
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Portable defibrillators that have jolted thousands of hearts back to life in airports, malls and homes are often subject to product recalls, a decade-long study of the complex devices said on Tuesday.
“The chances that your (automated external defibrillator) would be recalled in any given year was 1 in 20. The chances that your (device) would be recalled during the entire 10-year study period was 1 in 5,” said Dr. William Maisel of Beth Israel Deaconess Medical Center in Boston, who reviewed Food and Drug Administration advisories on the devices.
Just because a brand of defibrillator was recalled by the agency does not mean a particular version did not work, Maisel said, adding the agency’s approach appeared to have been “better safe than sorry.”
During the study period, there were 370 reported cases in which someone died after a defibrillator malfunctioned, according to the report published in this week’s issue of the Journal of the American Medical Association.
“The number of malfunctions pales in comparison to the number of lives that have been saved by these important devices over the past decade,” Maisel said.
Sudden cardiac death is the leading cause of death in the United States, accounting for nearly 330,000 fatalities annually. If applied quickly, a defibrillator can definitely save someone’s life, the study said.
Electrical and software problems prompted some of the recalls. The products, which come with computers that analyze the heartbeat and paddles that deliver a jolt of electricity, are different from internal defibrillators that are surgically implanted in the chests of heart patients.
Portable defibrillators, which tend to cost at least $1,500 and are made by several manufacturers, have become increasingly common in homes and public places such as arenas, shopping centers and airports—much like fire extinguishers.
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