BEUDAMED
    FDA Adverse Event Death Summary report: N

    TEMPUS LS-MANUAL

    MDR report key: 16312387 · Received February 7, 2023

    Report

    Report Number
    3003832357-2023-00033
    Event Type
    Death
    Date Received
    February 7, 2023
    Date of Event
    January 9, 2023
    Report Date
    August 1, 2024
    Manufacturer
    SCHILLER AG
    Product Code
    LDD
    UDI-DI
    07613365002737
    PMA / PMN Number
    K200849
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BASED ON INFORMATION PROVIDED BY PHILIPS REPAIR SERVICE PERSONNEL AND HAS BEEN INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS PRO INDICATING THAT THE DEVICE FAILED TO MONITOR PATIENT CORRECTLY, RHYTHM ASSESSMENT SHOWED V-FIB ON PRO MONITOR AND ASYSTOLE ON THE LS, DURING CARDIAC ARREST WHILE SYNCED. PATIENT PRONOUNCED AT ER. DISCLOSURE REPORT OF BOTH DEVICES REQUESTED BY SCHILLER FOR ANALYSIS. SCHILLER TEAM OBSERVED THAT THE DATE OF OCCURRENCE REPORTED IS INCORRECT. ONLY A SELF-TEST OCCURRED ON (B)(6) 2023. RESCUE FILES PROVIDED INDICATE THAT THE CORRECT DATE WOULD BE (B)(6) 2023. THIS WAS INVESTIGATED BY RDT AND THE CUSTOMER CONFIRMED THE NEW DATE. THE FULL DISCLOSURE ("FD") REPORT SHOWS THAT THE TEMPUS PRO RECEIVED THE SAME DATA AS THE TEMPUS LS DISPLAYED. IT IS STILL NOT CLEAR WHY THE DEFIBRILLATOR PADS ECG WAVEFORM WAS FLAT. SCHILLER TEAM OBSERVED THAT ECG I & II ARE THE SAME AND THIS CREATES THE QUESTION HOW THE CUSTOMER PLACED THE ECG ELECTRODES ON THE PATIENT. AS THE ECG I & II ARE MADE UP OF SIGNALS/ELECTRODES THAT SHOULD NOT BE NEAR EACH OTHER. IF THEY HAD BEEN PLACED CORRECTLY ON THE BODY IT WOULD BE HIGHLY UNLIKELY THAT THE WAVEFORMS WOULD MATCH UP. THE LOG AND RESCUE FILES WERE ANALYZED BY RDT TECHNICAL INVESTIGATOR. STABLE AND ACCEPTABLE IMPEDANCE WAS MEASURED BY DEFIB PADS WHEN PADS' ECG SHOWED FLAT LINE(ASYSTOLE), NO PROBLEM WITH DEFIB PADS CONNECTIVITY OBSERVED. FULL DISCLOSURE REPORT(M27-TEMPUS FULL DISCLOSURE REPORT (B)(6) 2023 13-54-30 SN(B)(6)) SHOWS THAT TEMPUS PRO ECG I & II WAVEFORMS MATCH WHICH IS HIGHLY UNLIKELY IF THE ECG ELECTRODES ARE PLACED CORRECTLY ON THE PATIENT BODY. ECG I & II CAN PROBABLY MATCH IF ELECTRODES ARE PLACED VERY NEAR TO EACH OTHER WHICH IS INCORRECT PLACEMENT OF ELECTRODES . LOG AND RESCUE FILES FROM THE DEVICES DO NOT CONTAIN ANY ERRORS OR ALARMS REGARDING THIS.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE DEVICE SHOWED 2 DIFFERENT RHYTHMS BETWEEN PRO AND LS DURING A CARDIAC ARREST WHILE SYNCED. THE PATIENT WAS PRONOUNCED AT ER. WITNESSED CARDIAC ARREST ON PATIENT ARRIVAL, RHYTHM ASSESSMENT SHOWED V-FIB ON PRO MONITOR AND ASYSTOLE ON THE LS. THE DEFIBRILLATED AND THE MONITOR STILL SHOWED V-FIB WHILE ASYSTOLE ON LS. 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 IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82321 TEMPUS LS-MANUAL LOW ENERGY DEFIBRILLATOR LDD SCHILLER AG 00-3020 07613365002737

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Death