BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OAKWORKS MEDICAL CFPM 400 IMAGING TABLE

    MDR report key: 6659989 · Received June 22, 2017

    Report

    Report Number
    2529571-2017-00002
    Event Type
    Malfunction
    Date Received
    June 22, 2017
    Date of Event
    August 19, 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
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INVESTIGATION NOTES, THE QUALITY INSPECTOR FOUND MARKS ON THE FOOT CONTROL CONSISTENT WITH DAMAGE RESULTING FROM THE FOOT CONTROL BEING CRUSHED UNDERNEATH OF THE COLUMN.

    Description of Event or Problem · 1

    THE FOOT PEDAL IS NOT OPERATING PROPERLY AND IT WILL START MOVING THE TABLE ON ITS OWN. THE BUTTON APPEARS TO BE STUCK. THIS HAS HAPPENED DURING PROCEDURES, BUT HAS NOT CAUSED ANY ADVERSE EVENTS. THE CUSTOMER HAS UNPLUGGED THE FOOT PEDAL AND IS USING JUST THE HAND CONTROL TO OPERATE THE TABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441886 OAKWORKS MEDICAL CFPM 400 IMAGING TABLE IMAGING TABLE IXR OAKWORKS, INC., CFPM 400

    Patients

    Seq Age Sex Outcome Treatment
    1