BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OAKWORKS MEDICAL CFPM 400 IMAGING TABLE

    MDR report key: 6660011 · Received June 22, 2017

    Report

    Report Number
    2529571-2017-00006
    Event Type
    Malfunction
    Date Received
    June 22, 2017
    Date of Event
    March 18, 2015
    Report Date
    June 6, 2017
    Manufacturer
    OAKWORKS, INC.,
    Product Code
    IXR
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RECURRING ISSUE.

    Description of Event or Problem · 1

    THE END USER CLINIC IS HAVING PROBLEMS WITH THE FOOT CONTROL. WHEN THEY WALK AROUND THE TABLE, THEY ARE KICKING THE FOOT CONTROL UP UNDER THE LOWER FRAME AND THE UP FUNCTION IS ENGAGING WITH THE PATIENT ON THE TABLE. THE NURSES ARE AWARE THAT THIS CAN AND DOES HAPPEN. THEY WERE ADVISED TO UNPLUG THE FOOT PEDAL AND USE ONLY THE HAND CONTROL. THE CUSTOMER STATED THAT NO PATIENT HARM HAD OCCURRED AS THEY WERE AWARE OF WHAT CAUSED THE MOVEMENT OF THE TABLE AND WERE ABLE TO REACT QUICKLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442014 OAKWORKS MEDICAL CFPM 400 IMAGING TABLE IMAGING TABLE IXR OAKWORKS, INC., CFPM 400

    Patients

    Seq Age Sex Outcome Treatment
    1