Description of Event or Problem · 0
IT HAS BEEN REPORTED TO PHILIPS THAT TEMPUS LS FAILED TO PACE WITH DEFIBRILLATOR PACING MODULE . A REPLACEMENT DEVICE WAS SENT TO THE CUSTOMER. LOG FILES AND RESCUE FILES WERE RECEIVED AT SCHILLER THE MANUFACTURER FOR A TECHNICAL INVESTIGATION. THE DEVICE WAS RETURNED TO RDT. 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. BASED ON THE INFORMATION AVAILABLE, NO FURTHER ACTION IS NECESSARY AT THIS TIME. ALTHOUGH NO HARM WAS REPORTED BY THE USER, GIVEN THE REPORTED CLINICAL SCENARIO, THE REPORTED DEVICE EVENT WILL BE CONSIDERED AN ADVERSE EVENT BECAUSE LIVE-SAVING THERAPY/TREATMENT WAS NOT AVAILABLE, INTERRUPTED, OR DELAYED AND MAY HAVE LED TO A DETERIORATION IN THE STATE OF THE HEALTH OF THE PATIENT. THE DATA ENTERED IN THIS COMPLAINT RECORD WILL BE UTILIZED FOR PRODUCT QUALITY AND SAFETY IMPROVEMENTS PER THE POST MARKET SURVEILLANCE AND RISK MANAGEMENT PROCESSES. A REPLACEMENT DEVICE WAS PROVIDED. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED.