BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINAC

    MDR report key: 4371474 · Received October 28, 2014

    Report

    Report Number
    4371474
    Event Type
    Malfunction
    Date Received
    October 28, 2014
    Date of Event
    September 24, 2014
    Report Date
    October 28, 2014
    Manufacturer
    VARIAN MEDICAL SYSTEMS INC.
    Product Code
    IYE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT RECEIVING RADIATION. WHILE PERFORMING A CONEBEAM CT ON THE PT THE HAND HELD ENABLER WAS RELEASED AND THE "BEEPING" SOUND REMAINED AS THOUGH THE BEAM WAS STILL ON. THE STAFF MEMEBER QUICKLY HIT THE EMERGENCY OFF BUTTON AND SHUT DOWN THE ENTIRE MACHINE. PT WAS REMOVED FROM THE ROOM. NO HARM TO PT. CONEBEAM CT WAS KEPT OUT OF SERVICE UNTIL EVLAUATED BY MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690434 CLINAC LINEAR ACCELERATOR IYE VARIAN MEDICAL SYSTEMS INC. 21EX *

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR