BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OAKWORKS MEDICAL CFPM 300 IMAGING TABLE

    MDR report key: 6660073 · Received June 22, 2017

    Report

    Report Number
    2529571-2017-00011
    Event Type
    Malfunction
    Date Received
    June 22, 2017
    Date of Event
    May 11, 2016
    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
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE END USER DAMAGED THE FOOT CONTROL. IT HAPPENED AT THE END OF THE DAY WHEN THEY WERE CLOSING UP THE ROOM. A STAFF MEMBER USED THE HAND CONTROL TO LOWER THE TABLE NOT REALIZING THE FOOT CONTROL WAS UNDER THE COLUMN AND CRUSHED THE FOOT CONTROL. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440510 OAKWORKS MEDICAL CFPM 300 IMAGING TABLE IMAGING TABLE IXR OAKWORKS, INC., CFPM 300

    Patients

    Seq Age Sex Outcome Treatment
    1