BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPUS LS-MANUAL

    MDR report key: 20181665 · Received September 10, 2024

    Report

    Report Number
    3003832357-2024-00673
    Event Type
    Malfunction
    Date Received
    September 10, 2024
    Date of Event
    August 29, 2024
    Report Date
    September 18, 2024
    Manufacturer
    SCHILLER AG
    Product Code
    LDD
    UDI-DI
    07613365002737
    PMA / PMN Number
    K200849
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PREVIOUSLY REPORTED ON (B)(4) WITH MDR #3003832357-2024-00652. DEVICE INVESTIGATION IS PENDING AND IS HOUSED ON (B)(4).

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE DEVICE IS UNABLE TO PACE WHILE DEVICE WAS BEING TESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2336390 TEMPUS LS-MANUAL LOW ENERGY DEFIBRILLATOR LDD SCHILLER AG 00-3020 07613365002737

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown