BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUMPER

    MDR report key: 9287967 · Received November 6, 2019

    Report

    Report Number
    1821850-2019-00003
    Event Type
    Malfunction
    Date Received
    November 6, 2019
    Date of Event
    September 3, 2019
    Report Date
    November 6, 2019
    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 NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. DISTRIBUTOR EVALUATED THE DEVICE, TESTING IT 8 TIMES RANGING FROM 15 MINUTES TO 70 MINUTES PER TEST SESSION, AND WERE UNABLE TO DUPLICATE THE REPORTED PROBLEM.

    Description of Event or Problem · 1

    THE USER REPORTED THAT UNDER 30:2 MODE, THE COMPRESSION PISTON WOULD NOT GO UP WHEN IT WAS VENTILATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1077731 THUMPER EXTERNAL CARDIAC COMPRESSOR DRM MICHIGAN INSTRUMENTS, LLC 1008 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR