BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPUS LS-MANUAL

    MDR report key: 18535569 · Received January 18, 2024

    Report

    Report Number
    3003832357-2024-00038
    Event Type
    Malfunction
    Date Received
    January 18, 2024
    Date of Event
    December 29, 2023
    Report Date
    July 23, 2024
    Manufacturer
    SCHILLER AG
    Product Code
    LDD
    PMA / PMN Number
    K200849
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED TO PHILIPS THAT THE DPM FAILED DURING TRAINING AND THE DEVICE WAS NOT USED ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817904 TEMPUS LS-MANUAL LOW ENERGY DEFIBRILLATOR LDD SCHILLER AG 00-3020

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other