BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OAKWORKS MEDICAL CFPM 400 IMAGING TABLE

    MDR report key: 6659993 · Received June 22, 2017

    Report

    Report Number
    2529571-2017-00003
    Event Type
    Malfunction
    Date Received
    June 22, 2017
    Date of Event
    August 29, 2014
    Report Date
    June 5, 2017
    Manufacturer
    OAKWORKS, INC.,
    Product Code
    IXR
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE FOOT CONTROL BUTTON WAS STUCK AND CAUSED THE TABLE TO MOVE INTO A LATERAL ROLL WHEN THEY WERE TRYING TO LOWER THE TABLE. THE PATIENT WAS ON THE TABLE AT THE TIME AS THE PROCEDURE HAD CONCLUDED AND THEY WERE ATTEMPTING TO GET THE PATIENT OFF THE TABLE WHEN THE UNINTENDED MOVEMENT OCCURRED. THE TOP WENT TO A 45 DEGREE ANGLE BEFORE THE UNINTENDED MOVEMENT STOPPED. IT TOOK THREE PEOPLE TO GET THE PATIENT OFF THE TABLE SAFELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441891 OAKWORKS MEDICAL CFPM 400 IMAGING TABLE IMAGING TABLE IXR OAKWORKS, INC., CFPM 400

    Patients

    Seq Age Sex Outcome Treatment
    1