FDAnews
www.fdanews.com/articles/121982-fda-investigates-defibrillator-energy-levels

FDA Investigates Defibrillator Energy Levels

November 6, 2009
The FDA is investigating energy levels in external biphasic defibrillators with shocks equal to or less than 200 Joules, the agency says in an initial communication to healthcare professionals. The FDA has received reports of 14 events since 2006 in which the defibrillators were ineffective, but a subsequent shock from a different 360 Joule defibrillator resulted in immediate defibrillation/cardioversion. So far, the agency is not suggesting changes in current clinical practices.