BEUDAMED
    FDA Adverse Event Other Summary report: N

    THUMPER

    MDR report key: 512448 · Received January 9, 2004

    Report

    Report Number
    1821850-2004-00002
    Event Type
    Other
    Date Received
    January 9, 2004
    Report Date
    January 9, 2004
    Manufacturer
    MICHIGAN INSTRUMENTS, INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE UNIT WAS BEING SET UP TO PROVIDE CPR TO A PATIENT IN CARDIAC ARREST. IT WAS REPORTED THAT AFTER SETUP IT WAS NOTICED THAT THE OXYGEN INPUT HOSE WAS NOT SECURE, SO THE DEVICE WAS REMOVED. THE UNIT WAS DAMAGED DURING THE REMOVAL. THE USER STATED THAT IT WAS BANGED AGAINST THE COT. THERE WAS NO DEATH OR SERIOUS INJURY INVOLVED IN THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THUMPER CARDIOPULMONARY RESUSCITATOR DRM MICHIGAN INSTRUMENTS, INC. 1005 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA