BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMULIX HP MARK 2

    MDR report key: 161560 · Received April 2, 1998

    Report

    Report Number
    1121753-1998-00010
    Event Type
    Malfunction
    Date Received
    April 2, 1998
    Date of Event
    February 4, 1998
    Report Date
    March 6, 1998
    Manufacturer
    NUCLETRON BV
    Product Code
    KPQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    FAD MOTOR TRANSMISSION APPEARS TO LEAK OIL INTO BRAKE ASSEMBLY OF OPPOSITE MOTOR, CAUSING BRAKE TO SLIP. THIS ALLOWS SEVERAL CENTIMETERS SLIPPAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIMULIX HP MARK 2 RADIATION THERAPY SIMULATION SYSTEM KPQ NUCLETRON BV 15T *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other