BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OAKWORKS MEDICAL CFPM 401 IMAGING TABLE

    MDR report key: 6659962 · Received June 22, 2017

    Report

    Report Number
    2529571-2017-00001
    Event Type
    Malfunction
    Date Received
    June 22, 2017
    Date of Event
    August 14, 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
    KS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NOT RETURNED.

    Description of Event or Problem · 1

    THE COMPLAINT WAS RECEIVED BY OAKWORKS, INC., BY A CUSTOMER IN (B)(6). THE PHYSICIAN HAD VISITED AN OAKWORKS, INC., BOOTH AT A TRADE SHOW. HE EXPLAINED THAT HE HAD TRIALED A CFPM 401 IMAGING TABLE AND WANTED TO PROVIDE FEEDBACK. THERE WAS NO PATIENT INVOLVEMENT AND NO PROCEDURE. HE MERELY SHOWED THE OAKWORKS, INC. REPRESENTATIVE ON THE TABLE IN THE BOOTH AT THE TRADE SHOW THAT THE FOOD PEDAL CAN SLIP UNDER THE TABLE, CAUSING ONE OF THE POWER MOTIONS TO BE ACTIVATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442690 OAKWORKS MEDICAL CFPM 401 IMAGING TABLE IMAGING TABLE IXR OAKWORKS, INC., CFPM 401 NOT LISTED

    Patients

    Seq Age Sex Outcome Treatment
    1