This report is based on information provided by a philips field service engineer and schiller (equipment manufacturer) and has been investigated by the philips complaint handling team.A replacement device was sent to the customer.The log and rescue files and the device were received at schiller where a technical investigation was completed.Error 26 was observed on the log file on the event date.Schiller has identified that the defibrillator/pacemaker module (dpm) may encounter an issue where communication from the device mainboard and the dpm board fails.In this event, the device will halt pacing and an error message will be displayed 'dpm hardware failure'.The returned device was removed from service and processed following local procedures.Based on the information available and the testing conducted, the cause of the reported problem was a communication error from the main board to the dpm module, error 26 was observed on the logfile.The reported problem was confirmed.A replacement device was provided.Analysis was performed and investigation has been completed.The investigation concludes that no further action is required at this time.
|