BEUDAMED
    FDA Adverse Event Summary report: N

    RADIATION THERAPY SIMULTOR

    MDR report key: 10963 · Received January 18, 1994

    Report

    Report Number
    MW1000404
    Date Received
    January 18, 1994
    Date of Event
    November 15, 1993
    Manufacturer
    VARIAN ASSOC., INC.
    Product Code
    KPQ
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Description of Event or Problem · 1

    DURING THE PROCESS OF SIMULATION OF PT IT WAS FOUND THAT THERAPIST COULD STEP ON FLUOROSCOPY ACTIVATION FOOT PEDAL WITH DOOR OPEN AND FLUORO WOULD COME ON AND FLUORO INDICATOR WOULD COME ON, WHEN STEPPING ON THE FOOT PEDAL BELL DID NOT SOUND. PROBLEM WAS REPORTED TO CO AND AFTER SOME INVESTIGATION IT WAS FOUND THAT BY GROUNDING OPTO-COUPLER ON CPU I/O BOARD AND GROUNDING A RELAY, THE FLUORO UNIT COULD BE TURNED ON, WITH X-RAY INDICATOR LAMP ON AND DOOR OPEN. CO REPLACED I/O BOARD ON 11/18/93. PROBLEM HAS NOT RECURRED SINCE THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIATION THERAPY SIMULTOR KPQ VARIAN ASSOC., INC. XIMATRON "C-SERIES"

    Patients

    Seq Age Sex Outcome Treatment
    1 *