Cardiac Science Issues Nationwide Notification Regarding Voluntary Medical Device Correction

Washington, DC: Cardiac Science has issued a voluntary field correction after it was determined certain automated external defibrillators (AEDs) may experience a rare product issue in which the AED may not be able to deliver therapy during a resuscitation attempt.

Device failure may affect resuscitation of the patient, which could lead to serious adverse events or death. These AEDs have electronic components which may fail and the failure may not be detected by the device's periodic self-tests. The affected models include the Powerheart 9300A, 9300C, 9300D, 9300E, 9300P, 9390A, 9390E, and CardioVive 92531, 92532, and 92533 devices.

Cardiac Science has received a total of 64 complaints concerning four resistors within certain AEDs. Two of these complaints were associated with a failure to deliver therapy. This issue is predicted to occur in approximately one in 75,000 AEDs manufactured between August 2003 and August 2009.

The company has also received 114 complaints regarding "Service Required" messages resulting from a specific relay switch failure.

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Published on Nov-16-09