BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BK-200

    MDR report key: 7364895 · Received March 23, 2018

    Report

    Report Number
    8030233-2018-00001
    Event Type
    Malfunction
    Date Received
    March 23, 2018
    Date of Event
    February 13, 2018
    Report Date
    March 14, 2018
    Manufacturer
    SHIMADZU COPORATION
    Product Code
    IXQ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHEN THE OPERATOR MOVED THE TABLE TOP PLATE OF BK-200 IN THE LONGITUDINAL DIRECTION, THE LITTLE FINGER OF THE RIGHT HAND HOLDING THE EDGE OF THE TABLE TOP BOARD WAS GOT CAUGHT BETWEEN THE BOTTOM OF THE TOP PLATE AND THE MAIN BODY BASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211105 BK-200 RADIOLOGIC TABLE IXQ SHIMADZU COPORATION 503-61750-32

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR