- Powerheart models 9300A, 9300C, 9300D, 9300E, 9300P, 9390A, 9390E; and
- CardioVive 92531, 92532 , and 9253
Because the AED display screen and/or audible indicators may not accurately indicate whether the device is functioning properly or will function properly at time of use, FDA encourages users of the affected AEDs to follow the additional precautions provided in this communication. FDA is gathering more data about this situation to better understand its potential public health impact and will make available any new information that might affect the use of these AED devices. Prompt reporting of adverse events can help FDA identify and better understand the risks associated with medical devices. FDA encourages anyone who suspects any electronic or mechanical problem(s) with an AED to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting Program.