Portable heart defibrillators prone to recalls
CHICAGO (Reuters) – 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 one in 20. The chances
that your (device) would be recalled during the entire 10-year
study period was one in five,” 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.