www.safetyandhealthmagazine.com/articles/fda-warns-of-faulty-components-in-14-aed-models-2

FDA warns of faulty components in 14 AED models

April 29, 2010

Approximately 280,000 automated external defibrillators in use may be at risk of malfunctioning, the Food and Drug Administration warned this week.

AEDs deliver an electric shock to the heart to restore a normal rhythm in the event of a sudden cardiac arrest. However, 14 defibrillator models manufactured by Bothell, WA-based Cardiac Science Corp. may fail to properly deliver a shock. The devices also may fail to properly analyze heart rhythm.

Affected models include:

  • Powerheart models 9300A, 9300C, 9300D, 9300E, 9300P, 9390A and 9390E
  • CardioVive models 92531, 92532 and 92533
  • Nihon Kohden models 9200G and 9231
  • GE Responder models 2019198 and 2023440
FDA recommended repairing or replacing these AEDs. If an alternative is not immediately accessible, the agency recommended continuing use of these devices, as they may still deliver necessary therapy.