BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPUS LS-MANUAL

    MDR report key: 20408232 · Received October 9, 2024

    Report

    Report Number
    3003832357-2024-00729
    Event Type
    Malfunction
    Date Received
    October 9, 2024
    Date of Event
    September 30, 2024
    Report Date
    January 14, 2025
    Manufacturer
    SCHILLER AG
    Product Code
    LDD
    UDI-DI
    07613365002737
    PMA / PMN Number
    K200849
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED TO PHILIPS THAT THE DEVICE FAILED TO PACE INDICATING A DEFIBRILLATION PACING MODULE (DPM) HARDWARE FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729734 TEMPUS LS-MANUAL LOW ENERGY DEFIBRILLATOR LDD SCHILLER AG 00-3020 07613365002737

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown