FDA Issues External Defibrillator Warning

WASHINGTON, April 27 (UPI) — The U.S. Food and Drug Administration issued a warning Tuesday that some external defibrillators used worldwide might malfunction.

The FDA said about 280,000 external defibrillators manufactured by the Cardiac Science Corp. and used in health care facilities, public places or in homes may contain faulty components that can cause the devices to malfunction.


The FDA said malfunctions might occur during attempts to rescue people in sudden cardiac arrest — a condition in which the heart suddenly stops beating. External defibrillators are used to send an electric shock to the heart to restore normal heart rhythm.

“In addition to failure to deliver needed shocks, other problems with the affected models may include interruption of electrocardiography analysis, failure to recognize electrode pads and interference or background noise that makes the device unable to accurately analyze heart rhythm,” the FDA said.

The affected 14 models, which include automated and semi-automated devices, are:

– Powerheart models 9300A, 9300C, 9300D, 9300E, 9300P, 9390A and 9390E.

– CardioVive models 92531, 92532 and 92533.

– Nihon Kohden models 9200G and 9231.

– GE Responder models 2019198 and 2023440.

The FDA recommends obtaining alternative external defibrillators and arranging for the repair or replacement of the affected defibrillators.

If no alternative external defibrillators are available, the FDA recommends continuing to use the affected devices if needed, because they may still deliver necessary therapy.

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