FDA Investigating External-Defib Energy Levels


November 11, 2009

November 11, 2009 (Silver Spring, Maryland) — The FDA is telling healthcare professionals that it "is investigating energy levels in external biphasic defibrillators with shocks <200 J" following 14 reports since 2006 of situations in which such devices failed to achieve defibrillation/cardioversion in a patient, who then successfully received therapy from a separate 360-J biphasic defibrillator [1]. Most of the cases involved attempts to cardiovert atrial fibrillation.

The agency isn't currently considering any changes to current practice based on these cases, it says, but "is seeking additional information in order to interpret the significance of these events and to determine whether FDA activities are advised." It's asking that experiences with defibrillators in which a patient required shocks from more than one device be reported to the MEDWATCH program.