BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUMPER

    MDR report key: 12580263 · Received October 5, 2021

    Report

    Report Number
    1821850-2021-00001
    Event Type
    Malfunction
    Date Received
    October 5, 2021
    Date of Event
    August 10, 2021
    Report Date
    October 5, 2021
    Manufacturer
    MICHIGAN INSTRUMENTS, LLC
    Product Code
    DRM
    PMA / PMN Number
    K073079
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS EVALUATED BY THE DISTRIBUTOR (TRAINED & CERTIFIED BY THE MANUFACTURER) WHO WAS UNABLE TO CONFIRM/REPEAT THE CUSTOMER'S INITIAL COMPLAINT. TIMING REGULATOR REPLACED BY DISTRIBUTOR, TESTED AND RETURNED TO CUSTOMER.

    Description of Event or Problem · 1

    AFTER 20 MINUTES OF OPERATION, DEVICE STOPPED WITH COMPRESSION DEPATH AT 4CM WITH NO RESPONSE FROM CONTROLS. DEVICE WAS DISCONNECTED FROM OXYGEN SUPPLY AND COMPRESSION DEPTH RETURNED TO 0CM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1474765 THUMPER EXTERNAL CARDIAC COMPRESSOR DRM MICHIGAN INSTRUMENTS, LLC 1008 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR