BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OAKWORKS MEDICAL CFPM 400 IMAGING TABLE

    MDR report key: 6660022 · Received June 22, 2017

    Report

    Report Number
    2529571-2017-00008
    Event Type
    Malfunction
    Date Received
    June 22, 2017
    Date of Event
    October 1, 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
    LA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE FOOT PEDAL BUTTONS ARE STICKING DUE TO DAMAGE CAUSED BY THE COLUMN BEING LOWERED ONTO THE FOOT PEDAL. THE CUSTOMER IS USING THE HAND CONTROL. THERE WAS NO PATIENT HARM OR ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440125 OAKWORKS MEDICAL CFPM 400 IMAGING TABLE IMAGING TABLE IXR OAKWORKS, INC., CFPM 400

    Patients

    Seq Age Sex Outcome Treatment
    1