BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPUS LS-MANUAL

    MDR report key: 14697837 · Received June 15, 2022

    Report

    Report Number
    3003832357-2022-00007
    Event Type
    Malfunction
    Date Received
    June 15, 2022
    Date of Event
    May 18, 2022
    Manufacturer
    SCHILLER AG
    Product Code
    LDD
    UDI-DI
    07613365002737
    PMA / PMN Number
    K200849
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IT HAS BEEN REPORTED TO PHILIPS THAT PATIENT PRESENTED TO EMS PROVIDERS TO BE IN COMPLETE 3RD DEGREE HEART BLOCK WITH A RATE OF 20-30 BPM.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BASED ON INFORMATION PROVIDED BY PHILIPS REMOTE SERVICE ENGINEER AND SCHILLER INVESTIGATION TEAM AND HAS BEEN INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS LS INDICATING THAT DEVICE FAILED TO PACE. CUSTOMER COMPLETED THERAPY WITH ANOTHER TEMPUS LS. THIS CAUSED THE DELAY IN THE TREATMENT OF ABOUT 15 MIN. THE COMPLAINT WAS ESCALATED FOR TECHNICAL INVESTIGATION. THE LOGS AND THE DEVICE REQUESTED BY RDT FOR INVESTIGATION. DEVICE RECEIVED AND THE ERROR 26 WAS OBSERVED. CONSIDERING ALL INVESTIGATION RESULTS, SCHILLER AG THE MANUFACTURER 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. DEVICE TRANSFERRED TO LOANER POOL AND IT NEEDS DPM UPGRADE. THE CUSTOMER WAS GIVEN THE REPLACEMENT DEVICE. 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

    CUSTOMER REPORTS THAT 'UNABLE TO PACE PATIENT WITH THIS UNIT. COMPLETED THERAPY WITH ANOTHER TEMPUS LS. A USER REPORT WAS RECEIVED RELATED TO A REPORTED PRODUCT PROBLEM WHICH IS CURRENTLY BEING INVESTIGATED. AT THE TIME OF REPORTING, THE DEVICE HAS NOT YET BEEN RETURNED FOR INVESTIGATION. FURTHER UPDATES WILL BE PROVIDED WHEN THE DEVICE IS RECEIVED AND INVESTIGATION HAS PROGRESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2813836 TEMPUS LS-MANUAL LOW ENERGY DEFIBRILLATOR LDD SCHILLER AG 00-3020 07613365002737

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other