BEUDAMED
    FDA Adverse Event Death Summary report: N

    TEMPUS LS-MANUAL

    MDR report key: 16611315 · Received March 24, 2023

    Report

    Report Number
    3003832357-2023-00141
    Event Type
    Death
    Date Received
    March 24, 2023
    Date of Event
    March 1, 2023
    Report Date
    July 8, 2024
    Manufacturer
    SCHILLER AG
    Product Code
    LDD
    PMA / PMN Number
    K200849
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED TO PHILIPS THAT DURING A PATIENT USE EVENT, THE DEVICE GAVE THE PADS ERROR MESSAGE WITH TWO SETS OF PADS. THEY WERE UNABLE TO USE THE DEFIBRILLATOR FUNCTION AT ALL AND HAD TO RESORT TO USING THE POLICE PROVIDED AED. THE PATIENT DIED AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375119 TEMPUS LS-MANUAL LOW ENERGY DEFIBRILLATOR LDD SCHILLER AG 00-3020 Y051021-07

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Male Death