BEUDAMED
    FDA Adverse Event Death Summary report: N

    TEMPUS LS

    MDR report key: 22317990 · Received June 24, 2025

    Report

    Report Number
    3003832357-2025-000468
    Event Type
    Death
    Date Received
    June 24, 2025
    Date of Event
    June 18, 2025
    Report Date
    December 30, 2025
    Manufacturer
    REMOTE DIAGNOSTIC TECHNOLOGIES LTD.
    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 CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THIS REPORT IS BASED ON INFORMATION PROVIDED BY REMOTE SERVICE ENGINEER RSE AND IS CURRENTLY UNDER INVESTIGATION BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS LS MANUAL INDICATING THE SCREEN FAILED TO PROPERLY SHOW ECG (ELECTROCARDIOGRAM) RHYTHM WHILE ON A CALL. THE SCREEN WAS CLEANED AFTER RETURNING TO STATION, AND AS SOON AS PRESSURE WAS APPLIED, SCREEN BEGAN TO FUNCTION PROPERLY. THE PATIENT WAS IN CARDIAC ARREST AND BEING MONITORED THROUGH THE DEFIBRILLATOR PADS. THE ECG (ELECTROCARDIOGRAM) RHYTHM WAS SUCCESSFULLY DISPLAYED ON THE TEMPUS PRO, BUT NOT THE TEMPUS LS MANUAL, AS SUCH, DID NOT IMPACT THE CARE OR OUTCOME OF THIS PATIENT.

    Description of Event or Problem · 0

    THIS REPORT IS BASED ON INFORMATION PROVIDED BY REMOTE SERVICE ENGINEER RSE AND HAS BEEN INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS LS MANUAL INDICATING THE SCREEN FAILED TO PROPERLY SHOW ECG (ELECTROCARDIOGRAM) RHYTHM WHILE ON A CALL. THE SCREEN WAS CLEANED AFTER RETURNING TO STATION, AND AS SOON AS PRESSURE WAS APPLIED, SCREEN BEGAN TO FUNCTION PROPERLY. THE PATIENT WAS IN CARDIAC ARREST AND BEING MONITORED THROUGH THE DEFIBRILLATOR PADS. THE ECG (ELECTROCARDIOGRAM) RHYTHM WAS SUCCESSFULLY DISPLAYED ON THE TEMPUS PRO, BUT NOT THE TEMPUS LS MANUAL, AS SUCH, DID NOT IMPACT THE CARE OR OUTCOME OF THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2063750 TEMPUS LS LOW ENERGY DEFIBRILLATOR LDD REMOTE DIAGNOSTIC TECHNOLOGIES LTD. 00-3020 07613365002737

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death