FDA Adds New AEDs to Existing Class 1 Recall

WASHINGTON — The FDA has expanded its Class I recall of some automatic external defibrillators (AED) due to reports of malfunction.

The announcement adds to the recall issued in November of defective Powerheart and CardioVive AED models manufactured by Cardiac Science Corporation from August 2003 to August 2009.

The recall was again updated in February to include models of the CardioLife AED.

The most recent update now adds the Nihon Kohden and GE Responder models to the Cardiac Science Corporation recall and ups the number of affected devices to approximately 280,000, the FDA said in a statement on its website.

The devices may not deliver life-saving shocks to patients when in use. The devices may also experience interrupted electrocardiography analysis, failure to recognize pad placement, or pickup of background noise during heart rhythm analysis, all of which could potentially delay or prevent shocks from being delivered.

Although Cardiac Science Corporation released software patches to update the self-test function of the devices, the FDA found the update detects only some, but not all, of the possible defects. This error is compounded with a malfunctioning green light, which may issue a false positive that the device is operating properly.

New device models included in the recall are:

  • Nihon Kohden 9200G and 9231
  • GE Responder 2019198 and 2023440

The FDA recommended that sites with high-risk patients or frequent use of the AED contact the manufacturer to replace or repair the system or find and use an alternate device.

Those who use the defibrillator at home or have one publicly available should use an alternate until a replacement or repair can be arranged, the FDA said in a statement. If an alternate is unavailable, the agency said that the risk of using the potentially faulty device outweighs the risks of not delivering therapy through the AED.

The FDA asked device owners to include make, model, serial number, initial and final conditions of a patient, and description of events that occurred during device use when filing an Adverse Event Report for any of the devices.

Class I recalls cover devices with a reasonable probability of causing serious adverse reactions or death with use. The AED recall was upgraded to Class I on March 8.

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