BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OAKWORKS MEDICAL CFPM 400 IMAGING TABLE

    MDR report key: 6660013 · Received June 22, 2017

    Report

    Report Number
    2529571-2017-00007
    Event Type
    Malfunction
    Date Received
    June 22, 2017
    Date of Event
    July 23, 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
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ONE OF THE BUTTONS ON THE FOOT PEDAL IS STICKING. THERE WAS NO PATIENT HARM OR DELAY IN PROCEDURES. THE CUSTOMER IS USING THE HAND CONTROL AND WE ARE SENDING A REPLACEMENT FOOT PEDAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442419 OAKWORKS MEDICAL CFPM 400 IMAGING TABLE IMAGING TABLE IXR OAKWORKS, INC., CFPM 400

    Patients

    Seq Age Sex Outcome Treatment
    1