FDA Safety warning: External Biphasic Defibrillators

November 10, 4:33 PMPittsburgh History ExaminerDev Meyers

Previous Next

Comment Print Email RSS Subscribe

Subscribe

Get alerts when there is a new article from the Pittsburgh History Examiner. Read Examiner.com's terms of use.

Email Address   Include other special offers from Examiner.com Terms of Use

Initial Communication- 14 events reported in which 200 J biphasic defibrillator was ineffective in providing fibrillation/cardioversion therapy

Devices: External biphasic defibrillators that deliver energy levels ≤ 200 Joules (J), including monitor/defibrillators and automated external defibrillators (AEDs).

[Posted 11/10/2009] 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. The majority of events occurred during attempts at cardioversion of atrial fibrillation, but there was at least one instance with defibrillation of a ventricular arrhythmia as well. 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.