Defibrillator Manufacturer Warned by the FDA

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Medical device manufacturer Cardiac Science Corp. received a formal warning from the FDA demanding that they correct safety procedures used to manufacture defibrillators. The automated external defibrillators (AEDs) are used in public locations such as government offices, sports stadiums, shopping centers and schools. They are designed to treat heart attacks by restoring healthy heart rhythms. If one of these products malfunctioned medical, personnel could be unable to respond effectively to a life-threatening crisis.

The FDA warning letter stated that during an investigation of Cardiac Science Corp's Wisconsin plant they found many safety procedure violations including not adequately correcting previous violations. The FDA will not approve any additional applications for medical devices by Cardiac Science Corp. until they address these issues.