BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEMPUS LS-MANUAL

    MDR report key: 17780111 · Received September 20, 2023

    Report

    Report Number
    3003832357-2023-00610
    Event Type
    Injury
    Date Received
    September 20, 2023
    Date of Event
    April 25, 2023
    Manufacturer
    SCHILLER AG
    Product Code
    LDD
    PMA / PMN Number
    K200849
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE TYPE OF REPORTED COMPLAINT HAS BEEN UPDATED FROM PRODUCT PROBLEM TO SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    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. PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS LS MANUAL INDICATING A DMP FAULT (UNABLE TO PACE). WHILE THE DEVICE WAS NOTED TO BE IN USE, THERE WAS REPORTEDLY NO PATIENT OR USER HARM OR IMPACT HOWEVER FAILURE TO SHOCK/PACE IS CONSIDERED A SERIOUS INJURY DUE TO A SERIOUS DETERIORATION OF HEALTH THAT MAY RESULT FROM A DELAY OR FAILURE TO SHOCK/PACE. 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 'PACE ERROR' WAS OBSERVED ON THE LOG FILE. SCHILLER HAS IDENTIFIED THAT THE DEFIBRILLATOR/PACEMAKER MODULE (DPM) MAY ENCOUNTER AN ISSUE WHERE COMMUNICATION FROM THE DEVICE MAIN BOARD AND THE DPM BOARD FAILS. IN THIS EVENT, THE DEVICE WILL HALT PACING AND AN ERROR MESSAGE WILL BE DISPLAYED 'DPM HARDWARE FAILURE'. SCHILLER CONCLUDED THAT 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 MAIN BOARD, 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. 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 CANNOT BE DETERMINED HOWEVER THE LIKELY CAUSE IS THE BOARD-TO-BOARD CONNECTOR BETWEEN THE DPM BOARD AND THE MAIN BOARD. THE REPORTED PROBLEM WAS CONFIRMED. BASED ON THE INFORMATION AVAILABLE AND RESULTS OF ADDITIONAL ANALYSIS FURTHER ACTION HAS BEEN INITIATED. A REVIEW OF THE RISK MANAGEMENT FILE WAS PERFORMED BY THE EQUIPMENT MANUFACTURER, SCHILLER. TEMPUS LS RISK ANALYSIS- SCHILLER QMS, VERSION 27 AND TEMPUS LS RISK MANAGEMENT PLAN - TEMPUS LS - SCHILLER QMS, VERSION 13 WERE REFERRED TO WHEN THE DECISION WAS MADE TO MAKE THE EVENT REPORTABLE. 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 CUSTOMER WAS PROVIDED A REPLACEMENT DEVICE TO RESOLVE THE ISSUE. IT HAS BEEN CONCLUDED THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED TO PHILIPS THAT TEMPUS LS HAS DPM FAULTS. A USER REPORT WAS RECEIVED RELATED TO A REPORTED PRODUCT PROBLEM WHICH IS CURRENTLY BEING INVESTIGATED. FURTHER UPDATES WILL BE PROVIDED WHEN THE INVESTIGATION IS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1590057 TEMPUS LS-MANUAL LOW ENERGY DEFIBRILLATOR LDD SCHILLER AG 00-3020

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other