BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPUS LS

    MDR report key: 20600325 · Received November 4, 2024

    Report

    Report Number
    3003832357-2024-00790
    Event Type
    Malfunction
    Date Received
    November 4, 2024
    Date of Event
    October 31, 2024
    Report Date
    March 5, 2025
    Manufacturer
    SCHILLER AG
    Product Code
    LDD
    UDI-DI
    07613365002737
    PMA / PMN Number
    K200849
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED TO PHILIPS THE DEVICE HAD A DPM HARDWARE FAILURE DISPLAYED ON UNIT, THIS WAS DISCOVERED DURING PREVENTATIVE MAINTENANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2181205 TEMPUS LS LOW ENERGY DEFIBRILLATOR LDD SCHILLER AG 00-3020 07613365002737

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown