BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUMPER

    MDR report key: 12585538 · Received October 6, 2021

    Report

    Report Number
    1821850-2021-00003
    Event Type
    Malfunction
    Date Received
    October 6, 2021
    Date of Event
    September 2, 2021
    Report Date
    October 6, 2021
    Manufacturer
    MICHIGAN INSTRUMENTS, LLC
    Product Code
    DRM
    PMA / PMN Number
    K073079
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    USER UNWILLING TO RETURN DEVICE TO DISTRIBUTOR FOR EVALUATION.

    Description of Event or Problem · 1

    AFTER 20 MINUTES OF OPERATION, DEVICE STOPPED WITH COMPRESSION DEPTH AT 4CM WITH NO RESPONSE FROM CONTROLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1484902 THUMPER EXTERNAL CARDIAC COMPRESSOR DRM MICHIGAN INSTRUMENTS, LLC 1008 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR