Product Details
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.Specifically, during a review of our Complaint and Service Log spreadsheet for the time frame of 7/30/2008 to 12/1/2010 and CCR/RMA reports, it was revealed that a number of customer calls classified as complaint and non-complaint situations where the AutoPulse System would stop operating pre-maturely due to battery/power issues, the emergency personnel had to revert to manual compressions. These events have not been reported to the Agency under the Medical Device Reporting requirements.