BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUMPER

    MDR report key: 12699662 · Received October 26, 2021

    Report

    Report Number
    1821850-2021-00004
    Event Type
    Malfunction
    Date Received
    October 26, 2021
    Date of Event
    September 15, 2021
    Report Date
    October 26, 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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DISTRIBUTOR REPLACED TIMING REGULATOR. DEVICE WAS TESTED TO FINAL TEST SPECIFICATIONS AND RETURNED TO CUSTOMER.

    Description of Event or Problem · 0

    REPORTED BY HEAD NURSE THAT THE DEVICE HAD STOPPED COMPRESSIONS DURING OPERATION SEVERAL TIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1599692 THUMPER EXTERNAL CARDIAC COMPRESSOR DRM MICHIGAN INSTRUMENTS, LLC 1008 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR Unknown