Updated Recall of 14 Cardiac Science AEDs

Disclosures

April 28, 2010

April 28, 2010 (Rockville, Maryland) — The Food and Drug Administration issued a warning Tuesday concerning more than a dozen faulty automated external defibrillators [1]. The safety alert affects approximately 280 000 devices made by Cardiac Science Corporation, the primary dysfunction being a failure to deliver a shock during the resuscitation attempt.

In addition to failing to deliver therapy, the problems with the defibrillators include an interruption of electrocardiography analysis that prevents shock delivery, a failure to recognize electrode placement during use, and interference or background noise that results in the device failing to accurately analyze the heart rhythm and deliver therapy, according to the agency.

"The FDA is issuing this notice so that users can take the proper steps necessary to ensure they have access to safe and effective defibrillators," Dr Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said in a statement [2].

The recall affects 14 models and includes Powerheart defibrillators (models 9300A, 9300C, 9300D, 9300E, 9300P, 9390A, and 9390E) and CardioVive defibrillators (models 92531, 92532, and 92533). Cardiac Science recalled these devices on November 13, 2009, as reported by heartwire , but the agency said other Cardiac Science devices, marketed by Nihon Kohden (models 9200G and 9231) and GE Healthcare (GE Responder models 2019198, and 2023440), have similar problems.

The FDA said that high-risk or frequent-use facilities, such as hospitals, ambulances, and clinics, should replace the defibrillators with another device or immediately arrange for repairs of the Cardiac Science defibrillator. Home users and public-access defibrillation programs should use alternative devices while awaiting repair of the Cardiac Science devices. If another device is not available, the affected defibrillator should be used, according to the agency, because the "consequences of not attempting to defibrillate a patient outweigh the risk that these devices may fail."

Cardiac Science issued a software update for two of the Powerheart defibrillators in February 2010 and plans to issue similar software updates for the other devices. The FDA said, however, that this new software addresses some but not all of the identified defects affected by the recall.

If an electronic or mechanical problem with one of the defibrillators is suspected, the FDA encourages individuals to file a report with MedWatch, the FDA Safety Information and Adverse Event Reporting program. Healthcare personnel employed by facilities should follow the procedures established by their facilities.

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