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November 16, 2010
FDA report: Defibrillators fail too often, cost lives
By Rob Stein
WASHINGTON — Defibrillators, those devices that are supposed to shock heart failure patients back to life, are malfunctioning far too often, costing people their lives, according to a report released Monday by the Food and Drug Administration.
In the past five years, the FDA's Center for Devices and Radiological Health has received more than 28,000 reports of defibrillators failing, and companies that make the devices have issued 68 recalls involving hundreds of the thousands of faulty devices, the FDA said. The problems appear to have been increasing rapidly over that period of time, the agency said.
Some of the specific examples are disturbing. In one case, a company designed a circuit that monitored the voltage in the device to draw power from the same source it was supposed to monitor. That caused a momentary drop in voltage, triggering a faulty signal to shut down the device, preventing it from delivering a shock. That may have caused a patient's death, the FDA said.
Because of the problems, the FDA announced a program aimed at helping companies develop safer, more effective defibrillators.
Nearly 300,000 Americans collapse each year when their hearts stop pumping blood. External defibrillators are designed to save their lives by diagnosing abnormal heart rhythm and re starting the heart by delivering a shock to the organ. The devices can be life-saving when used within the first few minutes after a cardiac arrest. They used to be found only in emergency rooms, but simpler versions that anyone can use, known as automated external defibrillators, are becoming more common in public settings, such as homes, airports and office buildings.
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