BEUDAMED
    FDA Adverse Event Death Summary report: N

    TEMPUS LS - MANUAL

    MDR report key: 14470262 · Received May 23, 2022

    Report

    Report Number
    3003832357-2022-00003
    Event Type
    Death
    Date Received
    May 23, 2022
    Date of Event
    April 26, 2022
    Manufacturer
    SCHILLER AG
    Product Code
    LDD
    UDI-DI
    07613365002737
    PMA / PMN Number
    K200849
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A USER REPORT WAS RECEIVED RELATED TO A REPORTED PATIENT DEATH 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.

    Description of Event or Problem · 0

    THE COMPLAINT AS DESCRIBED BY THE CUSTOMER - I RAN RUN #220039209 WHICH WAS A CARDIAC ARREST. PATIENT WENT IN TO VFIB AND I WAS ABLE TO SUCCESSFULLY DEFIBRILLATE THE PATIENT. AT THE NEXT PULSE CHECK PATIENT WAS FOUND IN VTACH WITHOUT A PULSE. THE MONITOR CHARGED BUT WHEN I HIT THE BUTTON TO DELIVER THE SHOCK, AN ERROR MESSAGE CAME ACROSS THE SCREEN STATING THE SHOCK WAS NOT DELIVERED DUE TO AN INTERNAL MALFUNCTION. I ATTEMPTED TO SHOCK AGAIN AND RECEIVED THE SAME MESSAGE. I ATTEMPTED TO DELIVER THE SHOCK FOUR TIMES AFTER THE FIRST SHOCK AND I GOT A MALFUNCTION ERROR ALL FOUR TIMES. THE INITIAL SHOCK DELIVERED WITHOUT A PROBLEM." THE MANUFACTURER (SCHILLER) REVIEWED THE LOG FILES. THE INVESTIGATION OF THE LOG FILES SHOWED THAT AFTER THE FIRST SUCCESSFUL SHOCK DELIVERY THE DEVICE ALWAYS DISCHARGED THE SHOCK INTERNALLY DUE TO FAILURE 6. WHY THE DEVICE WAS NOT ABLE TO DELIVER ANOTHER SHOCK AFTER THE FIRST SUCCESSFUL SHOCK IS NOT CLEAR NOW. THE INDICATED ERROR (INT. DISCHARGE 6) IS DISPLAYED IF THE MEASURED PATIENT CURRENT IS 0A OR GREATER THAN 105A DURING SHOCK DELIVERY. DURING A SELF-TEST, THE SHOCK DELIVERY TO A PATIENT (OR SIMULATOR) IS NOT CHECKED. THEREFORE, THE DEVICE MUST ALSO BE CHECKED FOR SHOCK DELIVERY BEFORE DAILY USE. WHICH WAS NOT DONE WITH THIS DEVICE (THERE IS ONLY THE AUTOMATIC SELF TEST AND THE INTERVENTION, THE DEVICE WAS NOT STARTED FOR THE DAILY TEST BY THE USER).

    Description of Event or Problem · 0

    THE COMPLAINT AS DESCRIBED BY THE CUSTOMER - I RAN RUN #(B)(4) WHICH WAS A CARDIAC ARREST. PATIENT WENT IN TO VFIB AND I WAS ABLE TO SUCCESSFULLY DEFIBRILLATE THE PATIENT. AT THE NEXT PULSE CHECK PATIENT WAS FOUND IN VTACH WITHOUT A PULSE. THE MONITOR CHARGED BUT WHEN I HIT THE BUTTON TO DELIVER THE SHOCK, AN ERROR MESSAGE CAME ACROSS THE SCREEN STATING THE SHOCK WAS NOT DELIVERED DUE TO AN INTERNAL MALFUNCTION. I ATTEMPTED TO SHOCK AGAIN AND RECEIVED THE SAME MESSAGE. I ATTEMPTED TO DELIVER THE SHOCK FOUR TIMES AFTER THE FIRST SHOCK AND I GOT A MALFUNCTION ERROR ALL FOUR TIMES. THE INITIAL SHOCK DELIVERED WITHOUT A PROBLEM." THE MANUFACTURER (SCHILLER) REVIEWED THE LOG FILES. THE INVESTIGATION OF THE LOG FILES SHOWED THAT AFTER THE FIRST SUCCESSFUL SHOCK DELIVERY THE DEVICE ALWAYS DISCHARGED THE SHOCK INTERNALLY DUE TO FAILURE 6. WHY THE DEVICE WAS NOT ABLE TO DELIVER ANOTHER SHOCK AFTER THE FIRST SUCCESSFUL SHOCK IS NOT CLEAR NOW. THE INDICATED ERROR (INT. DISCHARGE 6) IS DISPLAYED IF THE MEASURED PATIENT CURRENT IS 0A OR GREATER THAN 105A DURING SHOCK DELIVERY. DURING A SELF-TEST, THE SHOCK DELIVERY TO A PATIENT (OR SIMULATOR) IS NOT CHECKED. THEREFORE, THE DEVICE MUST ALSO BE CHECKED FOR SHOCK DELIVERY BEFORE DAILY USE. WHICH WAS NOT DONE WITH THIS DEVICE (THERE IS ONLY THE AUTOMATIC SELF TEST AND THE INTERVENTION, THE DEVICE WAS NOT STARTED FOR THE DAILY TEST BY THE USER). THE INVESTIGATION OF THE LOGFILE SHOWED THAT AFTER THE FIRST SUCCESSFUL SHOCK DELIVERY THE DEVICE ALWAYS DISCHARGED THE SHOCK INTERNALLY DUE TO FAILURE 6 THE DEVICE RETURNED ON 10TH JUNE 2022 AND INVESTIGATED BY THE MANUFACTURER SCHILLER. INCOMING INSPECTION AND ADDITIONAL TESTS WERE PERFORMED AT CUSTOMER SERVICE DEPARTMENT ON 14 JUNE 2022. THE DEVICE WAS CHECKED WITHOUT ANY PROBLEMS DURING THE INCOMING INSPECTION. THE FIRMWARE WAS ALREADY ON VERSION 1.3.5. THE PACER WORKED NORMALLY AT ALL CURRENTS AND FREQUENCIES. THE DEVICE WAS TESTED FURTHER AT R&D ON 15TH OF JUNE 2022. NO ERROR COULD BE DETECTED, SHOCK DELIVERY WAS POSSIBLE. SO THE CAUSE CANNOT BE EVALUATED. THE DEVICE FUNCTIONED AS INTENDED. THE FAILURE COULD NOT BE REPRODUCED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518599 TEMPUS LS - MANUAL LOW ENERGY DEBFIBRILLATOR LDD SCHILLER AG 00-3020 07613365002737

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death