BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEMPUS LS-MANUAL

    MDR report key: 19363936 · Received May 21, 2024

    Report

    Report Number
    3003832357-2024-00415
    Event Type
    Injury
    Date Received
    May 21, 2024
    Date of Event
    June 11, 2022
    Report Date
    August 6, 2024
    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
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED TYPE OF REPORTED COMPLAINT.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE DEVICE FAILED TO DISPLAY ECG IN PADS MODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584054 TEMPUS LS-MANUAL LOW ENERGY DEFIBRILLATOR LDD SCHILLER AG 00-3020 07613365002737

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening