BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OAKWORKS MEDICAL CFLU 401 LITHOTRIPSY/UROLOGY TABLE

    MDR report key: 6659997 · Received June 22, 2017

    Report

    Report Number
    2529571-2017-00004
    Event Type
    Malfunction
    Date Received
    June 22, 2017
    Date of Event
    November 24, 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
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER CALLED IN A PANIC BECAUSE THE COLUMN HAD BEEN LOWERED ONTO THE FOOT PEDAL WHILE A PATIENT WAS ON THE TABLE. BECAUSE THE COLUMN WAS ON THE PEDAL, THEY COULD NOT OPERATE THE TABLE AT ALL. THE CUSTOMER WAS WALKED THROUGH UNPLUGGING THE FOOT PEDAL SO THAT THE HAND CONTROL WOULD OPERATE. THIS WAS SUCCESSFUL. THERE WAS NO HARM DONE THE PATIENT. THE CUSTOMER IS STATING THAT THE FOOT PEDAL IS OPERATIONAL AND NO DAMAGE WAS DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441890 OAKWORKS MEDICAL CFLU 401 LITHOTRIPSY/UROLOGY TABLE IMAGING TABLE (LITHOTRIPSY/UROLOGY TABLE) IXR OAKWORKS, INC., CFLU 401

    Patients

    Seq Age Sex Outcome Treatment
    1