BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUMPER

    MDR report key: 9566048 · Received January 8, 2020

    Report

    Report Number
    1821850-2020-00001
    Event Type
    Malfunction
    Date Received
    January 8, 2020
    Date of Event
    December 9, 2019
    Report Date
    January 8, 2020
    Manufacturer
    MICHIGAN INSTRUMENTS, LLC
    Product Code
    DRM
    PMA / PMN Number
    K972525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. END USER WAS SENT A REPLACEMENT BASE AND REPORTED THAT IT ATTACHES PROPERLY WITH THE ARM/COLUMN ASSEMBLY.

    Description of Event or Problem · 1

    WHEN ATTEMPTING TO PERFORM MECHANICAL CPR TO THE PATIENT, WITHIN THE FIRST FEW COMPRESSIONS, THE ARM/COLUMN ASSEMBLY DISCONNECTED FROM THE BASE. IT WAS NOTED THE SUPPORT PIN ON THE BASE WAS BENT AND THE ARM/COLUMN ASSEMBLY COULD NOT BE RE-CONNECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29962 THUMPER EXTERNAL CARDIAC COMPRESSOR DRM MICHIGAN INSTRUMENTS, LLC 1007CC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR