WASHINGTON (CN) – Cardiac Science Corporation will fix defibrillators that customers have bought which may not be able to provide a shock during a resuscitation attempt, the Food and Drug Administration said.
Electronic components may fail in certain Powerheart and CardioVive automated external defibrillators (AEDs), which may not be detected by the devices’ self-tests, according to the company. The affected models include the Powerheart 9300A, 9300C, 9300D, 9300E, 9300P, 9390A, 9390E, and CardioVive 92531, 92532, and 92533 devices. Cardiac Science states that customers of these products will be notified immediately.
Cardiac Science has received 64 complaints concerning four resistors within certain AEDs, according to the press release. Two of the complaints included failure to deliver a shock. The company states that a software update to address the resistor issue will be available by May, and advises customers to follow the normal testing and maintenance procedures, until then.
Cardiac Science states that if the AED is not rescue ready (the indicator is red) customers should contact the company immediately.
The company claims that all AEDs produced since August 2009 are unaffected.