BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPUS LS MANUAL

    MDR report key: 17881396 · Received October 5, 2023

    Report

    Report Number
    3003832357-2023-00698
    Event Type
    Malfunction
    Date Received
    October 5, 2023
    Date of Event
    October 3, 2023
    Report Date
    July 1, 2024
    Manufacturer
    SCHILLER AG
    Product Code
    LDD
    UDI-DI
    07613365002737
    PMA / PMN Number
    K200849
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    FDA PRODUCT CODE UPDATED TO LDD.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE DEVICE IS FAILING SELF-TEST. THERE IS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2098349 TEMPUS LS MANUAL LOW ENERGY DEFIBRILLATOR LDD SCHILLER AG 00-3020 07613365002737
    2261262 TEMPUS LS MANUAL LOW ENERGY DEFIBRILLATOR LDD SCHILLER AG 00-3020 07613365002737

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown