BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEMPUS LS- MANUAL

    MDR report key: 19240411 · Received May 3, 2024

    Report

    Report Number
    3003832357-2024-00360
    Event Type
    Injury
    Date Received
    May 3, 2024
    Date of Event
    April 27, 2024
    Report Date
    August 13, 2024
    Manufacturer
    SCHILLER AG
    Product Code
    LDD
    UDI-DI
    07613365002737
    PMA / PMN Number
    K200849
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    NEW INFORMATION RECEIVED INDICATED EVENT DATE TO BE 27APR2024.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED TO PHILIPS THAT THE TEMPUS LS MANUAL HAS A PACING FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758338 TEMPUS LS- MANUAL LOW ENERGY DEFIBRILLATOR LDD SCHILLER AG 00-3020 07613365002737

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other