The FDA has issued warnings for Cardiac Science’s Powerheart and CardioVive automated external defibrillator (AED) G3 series, manufactured between August 2003 and August 2009, for the possibility of malfunction during use.
The problems stem from the AED devices' inadequacy to detect apparatus problems during its self-performed self-tests, according to the agency. The company said that the AED display screens and audible indicators may not accurately indicate whether the device is functioning properly or will function properly at the time of use.
The affected devices, used in the resuscitation of patients during sudden cardiac arrest, include Cardio Science’s:
- Powerheart models 9300A, 9300C, 9300D, 9300E, 9300P, 9390A, 9390E; and
- CardioVive models 92531, 92532 and 92533
The Bothell, Wash.-based company reported receiving 178 user complaints concerning the malfunction of the devices’ resisters and regarding faulty “service required” messages.
According to the FDA, 300,000 Cardiac Science AEDs globally have the potential to be affected by the problem.
The potential problems related to the devices include:
- An interruption of ECG analysis that prevents shock delivery;
- Failure to recognize pad (electrode) placement during use; and
- Interference or background noise that makes the device unable to accurately analyze the heart rhythm and deliver a shock, even if an ECG analysis is successfully conducted.
According to the FDA, users should use alternate AEDs if available until the Cardiac Science products have been repaired, and should immediately arrange for repairs or replacements to its AEDs.
The company has said it plans a technology upgrade in May 2010 to fix the problems associated with the devices. The FDA recommended using manual or other available AED devices and the continuous check of its status light indicator, until the problems are further researched.
The FDA encouraged users who detect problems with the Cardiac Science G3 devices to file a report through MedWatch, the FDA Safety Information and Adverse Event Reporting program to assist in the further detection of device blips.