Cardiac Science Issues AED Voluntary Medical Device Correction

Cardiac Science Corporation is initiating a voluntary field correction after it was determined certain automated external defibrillators may not be able to deliver therapy during a resuscitation attempt.

Affected models include the Powerheart 9300A, 9300C, 9300D, 9300E, 9300P, 9390A, 9390E, and CardioVive 92531, 92532, and 92533 devices manufactured between August 2003 and August 2009.

Device failure may affect resuscitation of the patient, which could lead to serious adverse events or death, according to the Bethell, Wash.-based firm.

Cardiac Science has received 64 complaints concerning four resistors within certain AEDs. Two of these complaints were associated with a failure to deliver therapy.

Until a correction is available in May 2010, the company advises customers to check the status indicator on the front of the AED and follow the procedures documented in the materials accompanying the AED.

The company has implemented more stringent testing of the components and all AEDs produced since August 2009 are unaffected, and a software update to address the resistor issue will be available by May 2010.