BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OAKWORKS MEDICAL (LINAK)

    MDR report key: 2487845 · Received March 6, 2012

    Report

    Report Number
    MW5024580
    Event Type
    Malfunction
    Date Received
    March 6, 2012
    Date of Event
    March 3, 2012
    Report Date
    March 6, 2012
    Manufacturer
    OAKWORKS, INC.
    Product Code
    IXR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TABLE HAS 4 WHEELS, 2 OF WHICH WERE DIFFICULT TO LOCK AND WAS MOVING TO A VERY RESTLESS AND AGITATED PT. NO HARM TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OAKWORKS MEDICAL (LINAK) C-ARM TABLE (X-RAY) IXR OAKWORKS, INC. CB16414-501021J

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other