BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMATRON SIMULATOR

    MDR report key: 28799 · Received November 7, 1995

    Report

    Report Number
    MW4000962
    Event Type
    Malfunction
    Date Received
    November 7, 1995
    Date of Event
    October 27, 1995
    Report Date
    October 31, 1995
    Manufacturer
    VARIAN ASSOC, INC.
    Product Code
    KPQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    WHILE ROTATING GANTRY WITH HAND PENDANT, THE MACHINE AND PENDANT BOTH SWITCHED INTO AUTO-RIGHT LATERAL PELVIS SETUP MODE - AND THE MACHINE COMPONENTS STARTED TO MOVE INTO THE DESIGNATED POSITIONS. THE MOTIONS STOPPED WHEN THE ENABLE BARS WERE RELEASED. WHILE MOVING GANTRY WITH HAND PENDANT, THE TABLE MOVED FORWARD IN THE LONGITUDINAL DIRECTION ABOUT 3" ON ITS OWN. WHILE MOVING THE GANTRY AND COUCH LATERALLY (UNLOCKED-MANUALLY), THE COUCH LOCKED THEN UNLOCKED WITHOUT ANYONE HITTING THE BRAKE RELEASE PUSHBUTTON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMATRON SIMULATOR ZIMATRON SIMULATOR KPQ VARIAN ASSOC, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 *