On November 10, 2009, the FDA released a statement informing healthcare professionals that it is investigating energy levels in external biphasic defibrillators. This notification concerns all external defibrillators that deliver energy levels less than 200 Joules, including monitor/defibrillators and automated external defibrillators (AED’s).
There have been 14 events reported since 2006 in which 200 Joule bi-phasic defribillators did not restore a normal heartbeat and more powerful defibrillators had to be used. In these instances, 360 Joule bi-phasic defibrillators provided effective therapy immediately and achieved defibrillation or cardioversion.
FDA says that, “analysis of the 14 cases does not suggest the need for any change to current clinical practice,” but as it evaluates the situation, encourages providers to pay attention to American Heart Association’s guidelines and manufacturer’s instructions for using defibrillators.
FDA is seeking additional information in order to help them better understand these events and suggests:
If you suspect a problem with a defibrillator, you should report this problem to the FDA's MedWatch Safety Information and Adverse Event Reporting Program online at MedWatch Adverse Event Reporting or by phone 1-800-332-1088.
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