FDA Warns of Problems With External Biphasic Defibrillators

The Food and Drug Administration is warning medical professionals about external biphasic defibrillators which may deliver weaker electrical shocks than are needed to restart the heart in a medical emergency.

Since 2006, the FDA has received 14 reports of situations where a 200 Joules biphasic defibrillator was ineffective in providing either defibrillation or cardioversion in patients treated with the life-saving devices. In some of those cases, a shot from a different, more powerful biphasic defibrillator was necessary to immediately achieve the desired improvement in the patient’s condition, the FDA said.

“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,” the FDA said in warning of the defibrillator problems.

The FDA warning pertains to external biphasic defibrillators that deliver energy levels less than 200 Joules, including monitor/defibrillators and automated external defibrillators (AEDs).

Officials are continuing to investigate the reports of problems, but the preliminary analysis does not indicate a change is needed in the policies and procedures for use of defibrillators, the FDA said.

“So far, our analysis of the 14 cases does NOT suggest the need for any change to current clinical practice,” the FDA said in a statement about the warning.

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