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FDA cautions against use of some CardioVive automated external defibrillator models
A self-test on the device may not be able to detect the manufacturing defect that causes the device malfunction.
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The FDA has urged providers to exercise additional caution in the use of certain models of the CardioVive automated external defibrillators due to defective components.
According to an agency document, the manufacturer Cardiac Science Corporation has received numerous complaints related to defective components of the device. Specifically, the agency reported that the affected models may not deliver an electric shock and that the self-test on the device may not able to detect the defect. Problems with the device include the interruption of electrocardiography analysis that prevents shock delivery; the failure to recognize electrode placement during use; and interference/background noise that makes the device unable to accurately measure heart rhythm.
The affected models are part of the G3 series of the CardioVive defibrillator manufactured between August 2003 and August 2009 and include Powerheart models 9300A, 9300C, 9300D, 9300E, 9300P, 9390A, 9390E and CardioVive 92531, 92532 and 9253. Approximately 300,000 devices worldwide may be affected by the defect.
The FDA recommended that care providers using the affected models take additional precautions, including the use of other automatic external defibrillators (if available), and if no alternative is available to try to use the device, as it may still deliver the needed shock therapy. Providers are urged to take note of the make, model and serial numbers of the devices; the initial and final conditions of the patient; and a description of the device problem in their reports to the manufacturer and the FDA.