BEUDAMED
    FDA Adverse Event Death Summary report: N

    TEMPUS LS-MANUAL

    MDR report key: 17264094 · Received July 6, 2023

    Report

    Report Number
    3003832357-2023-00444
    Event Type
    Death
    Date Received
    July 6, 2023
    Date of Event
    June 4, 2023
    Manufacturer
    SCHILLER AG
    Product Code
    LDD
    UDI-DI
    07613365002737
    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

    Additional Manufacturer Narrative · 0

    EVENT DATE UPDATED TO 04JUN2023.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THE DEVICE FAILS PACING, GOES INTO FAULT MODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    885504 TEMPUS LS-MANUAL LOW ENERGY DEFIBRILLATOR LDD SCHILLER AG 00-3020 07613365002737

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Death