BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPUS LS

    MDR report key: 18652487 · Received February 6, 2024

    Report

    Report Number
    3003832357-2024-00096
    Event Type
    Malfunction
    Date Received
    February 6, 2024
    Report Date
    August 5, 2024
    Manufacturer
    SCHILLER AG
    Product Code
    LDD
    UDI-DI
    07613365002737
    PMA / PMN Number
    K200849
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED TO PHILIPS THE UNIT FAILED TO PACE AND DISPLAYED ERROR "DPM HARDWARE FAILURE" DURING PM. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2086421 TEMPUS LS LOW ENERGY DEFIBRILLATOR LDD SCHILLER AG 00-3020 07613365002737

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown