External Biphasic Defibrillators Energy Levels: Initial Communication
MedSun: Newsletter #43, December 2009

FDA MedWatch Safety Alert

FDA notified healthcare professionals that it is investigating energy levels in external biphasic defibrillators with shocks = 200 J. FDA received reports of 14 events since 2006 in which a 200 J biphasic defibrillator was ineffective in providing defibrillation/cardioversion therapy to a patient, whereas a subsequent shock from a different 360 J biphasic defibrillator resulted in immediate defibrillation/cardioversion. Analysis of the 14 cases does not suggest the need for any change to current clinical practice, and as FDA continues its evaluation of this situation, providers are encouraged to follow the American Heart Association’s guidelines/algorithms for treatment of cardiac arrhythmias, and to follow manufacturers’ instructions for using defibrillators. FDA is seeking additional information in order to interpret the significance of these events, and to determine whether FDA activities are advised.

Additional Information:

FDA MedWatch Safety Alert. External Biphasic Defibrillators Energy Levels: Initial Communication. November 10, 2009.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm189259.htm


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