NYT,pg1: Flawed (defibrillator) Places F.D.A. Under Scrutiny

[DeepModem Mom]

Flawed Device Places F.D.A. Under Scrutiny
By BARRY MEIER

Published: December 15, 2004


The Red Rooster III was 90 miles out of San Diego on an afternoon in July when it came across a fisherman's dream, a school of albacore tuna. Suddenly, the charter boat's skipper, John Grabowski, saw a rod flying in the air as a passenger, a 72-year-old man, seized up with a heart attack. Mr. Grabowski ran to get the portable defibrillator kept on board.

Shocked with the device, the man appeared to revive, but more shocks were needed. They never came. The device signaled that it was out of power and failed to work again. A replacement battery did not help because its power had been drained. Soon afterward, the man died.

Last month, Mr. Grabowski learned more about the device. Its maker, Access Cardiosystems, of Concord, Mass., recalled all 18,500 defibrillators it had produced since going into business two years earlier....

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A look at the history of Access Cardiosystems raises questions about its products. But the Food and Drug Administration's oversight of the defibrillator may reveal shortcomings in its regulation of medical devices, a category that includes products as diverse as blood-oxygen monitors and artificial hips....


http://www.nytimes.com/2004/12/15/business/15device.html