Defective External Defibrillator Components in 280,000 Units, FDA Warns

Federal regulators are warning that about 280,000 external defibrillators may have defective components which could cause them to malfunction during crucial life-saving measures. 

The defibrillator warning was issued this week by FDA, which says that 14 models of external defibrillators have faulty components manufactured by Cardiac Science Corp. of Bothell, Washington. Although there have been no injuries reported in connection with the defective defibrillators, the components may cause the device to fail to deliver shocks needed to save someone’s life.

The warning is an expansion of a previous external defibrillator recall by the company. FDA announced that Cardiac Science recalled about 12,200 automated external defibrillators (AEDs) on February 3. However, the FDA has since learned that the problem exists in a number of other defibrillators as well.

About 280,000 automated and semi-automated defibrillators have the components. Defibrillators affected by the defective components include:

• Powerheart models 9300A, 9300C, 9300D, 9300E, 9300P, 9390A and 9390E
• CardioVive models 92531, 92532 and 92533
• Nihon Kohden models 9200G and 9231 and
• GE Responder models 2019198 and 2023440.

The FDA is not recalling the affected units, saying that the potential benefits of having them available outweigh the risk of a malfunction. However, the agency recommended that hospitals, nursing homes and other high-risk settings use alternative defibrillators and arrange for defibrillators affected by the recall to be repaired or replaced. Other users of the affected defibrillators should try to get the unit repaired or replaced, and should use an alternate defibrillator in the meantime, if one is available.