Automated External Defibrillator - Reliability

Reliability

Automated external defibrillators are under recent scrutiny by the FDA which is now considering reclassifying AEDs as class III premarket approval devices. The major reason for this appears to be technical malfunctions that may have been the cause for apparently hundreds of deaths between 2004 and 2009, in most cases by component failures or design errors. Over the last several years dozens of AED models have been recalled from nearly every manufacturer.