Description of Event or Problem · 0
PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS LS INDICATING THAT THE DEVICE FAILED TO PACE WHILE ON A SIMULATOR. NO PATIENT INVOLVED OR HARMED. THE DEVICE REQUESTED FROM THE CUSTOMER AND REPLACEMENT DEVICE HAS BEEN SENT. THE COMPLAINT WAS ESCALATED FOR TECHNICAL INVESTIGATION AND THE RESULTS INDICATE THAT ERROR 26 HAS BEEN DETECTED ON THIS DEVICE, WHICH OCCURRED ON 2022-04-11, NOT (B)(6) 2022. CONSIDERING ALL INVESTIGATION RESULTS, SCHILLER CONCLUDED THAT THIS ISSUE IS MOST LIKELY DUE TO AN INTERMITTENT LOSS OF COMMUNICATION BETWEEN THE DPM-BOARD AND THE MAINBOARD. AS THE ISSUE IS NOT CLEARLY REPRODUCIBLE, THE EXACT ROOT CAUSE CANNOT BE DETERMINED. HOWEVER, TAKING ALL COMPONENTS INTO ACCOUNT WHICH ARE PART OF THE COMMUNICATION PATH BETWEEN THE DPM-BOARD AND THE MAINBOARD, AND WHICH MAY CAUSE AN INTERMITTENT LOSS OF COMMUNICATION, THE SOURCE OF THE ISSUE IS MOST LIKELY TO BE OF A MECHANICAL NATURE SUCH AS A CONNECTOR. THEREFORE, IT IS SUSPECTED THAT THE BOARD-TO-BOARD CONNECTOR BETWEEN THE DPM-BOARD AND THE MAINBOARD MAY BE THE ROOT CAUSE FOR THIS ISSUE. AS THE ROOT CAUSE CANNOT BE VERIFIED, SCHILLER AG CANNOT COME TO A CONCLUSION. 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. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED.