FDA knew more than 28,000 defibrillators were defective and evidence suggests the companies that sold them were also aware of the defects.

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 last 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. And 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.

But the FDA has become increasingly concerned about rapidly rising reports of problems with the devices. After studying the problem, the agency concluded that many of the failures could be prevented by improving the design and manufacturing practices of the companies that make the devices. For example, in several cases companies bought components for the devices from suppliers that did not meet the required specifications. In another case a firm knew about a defect in its device and fixed the problem on a case-by-case basis but never systematically notified other users of the problem so their devices could be checked and fixed if necessary before any problems occurred.


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