BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUMPER

    MDR report key: 8112350 · Received November 28, 2018

    Report

    Report Number
    1821850-2018-00003
    Event Type
    Malfunction
    Date Received
    November 28, 2018
    Date of Event
    November 16, 2018
    Report Date
    November 28, 2018
    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 RECEIVED IN FAIR CONDITION. CUSTOMER COMPLAINT THAT THE DEVICE WOULD NOT ADJUST COMPRESSION IS CONFIRMED. THE KNOB IS SPINNING AROUND THE CDNV STEM AND NOT ALLOWING THE COMPRESSION DEPTH TO CHANGE. THE SET SCREW HOLDING THE KNOB TO THE STEM HAD STRIPPED OUT. REPLACED CDNV KNOB WITH DOUBLE SET SCREW TO PREVENT THE KNOB FROM SPINNING FREELY. CLEANED AND RE-LUBED PISTON DOME. CHECKED. TESTED, AND ACCEPTED TO TS234. THE DEVICE WAS RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS BEING SET UP ON A PATIENT TO PERFORM CPR. IT WAS REPORTED THE DEVICE'S CHEST DEPTH NEEDLE VALVE KNOB WAS SPINNING FREELY AND NOT ENGAGING THE CHEST DEPTH ON THE DEVICE. DEVICE WAS REMOVED FROM THE PATIENT AND MANUAL CPR WAS APPLIED. THE PATIENT WAS NOT REVIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    950877 THUMPER EXTERNAL CARDIAC COMPRESSOR DRM MICHIGAN INSTRUMENTS, LLC 1007CC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR