Normally, users of these devices should always check the status indicator on the front of the external defibrillator and/or audible indicators to see whether the device is rescue-ready (green light is displayed). However, the presence of a green light on the affected devices may not reveal defective or non-working components inside the external defibrillators and give a false sense that they are in proper working order. Updated recommendations and complete list of affected models can be found in the 04/27/2010 Medical Device Update.
[Posted 03/08/2010] Cardiac Science Corporation and FDA notified healthcare professionals and consumers of a Class 1 recall of automated external defibrillators (AED). These devices may not deliver therapy during a resuscitation attempt. Defects in certain electronic components may not be detected by the device’s Daily/Weekly/Monthly self-tests. These defects can cause improper functioning of the device during a rescue attempt, which may prevent resuscitation. This can lead to serious adverse health events and/or death. List of affected models includes:
- Powerheart 9300A, 9300C, 9300D, 9300E, 9300P, 9390A, 9390E
- CardioVive 92531, 92532, 92533
- NK 9200G, 9231
- Responder 2019198 and 2023440.
[04/27/2010 - Update on Defective Cardiac Science Corporation External Defibrillators1 - FDA]
[03/08/2010 - Recall Notice2 - FDA]