BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VARIAN CLINAC

    MDR report key: 1183243 · Received October 1, 2008

    Report

    Report Number
    1183243
    Event Type
    Malfunction
    Date Received
    October 1, 2008
    Date of Event
    September 30, 2008
    Report Date
    October 1, 2008
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Product Code
    IYE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RADIATION ONCOLOGY TECH NOTED SMOKE EMITTING FROM RADIATION ONCOLOGY VARIAN LINEAR ACCELERATOR AT 8:55 AM. EMERGENCY STOP WAS DEPRESSED TO CUT OFF AC POWER TO UNIT. SMOKE ACTIVATED SMOKE DETECTOR WHICH NOTIFIED FACILITY SECURITY AND LOCAL FIRE DEPARTMENT, BOTH WHO RESPONDED PROMPTLY. BIOMED AND THE PHYSICIST RESPONDED TO THE SCENE AND THE BIOMED ENGINEER SHUT THE MAIN CIRCUIT BREAKER THAT FED ACCELERATOR AS AN ADDITIONAL SAFETY PRECAUTION. PATIENTS IN THE IMMEDIATE AREA WERE RELOCATED. FIRE OFFICIALS INSTRUCTED PERSONNEL TO EVACUATE PATIENTS EXTERNAL TO THE BUILDING DUE TO THE PRESENCE OF SMOKE AND SMELL IN THE AREA. NO PATIENT WAS UNDERGOING TREATMENT AT THAT TIME. ONE PATIENT HAD COMPLETED TREATMENT AT 8:39 A.M. AND HAD LEFT THE ACCELERATOR ROOM. PERSONNEL ASSISTED THE FIRE DEPARTMENT IN INVESTIGATING THE CAUSE OF THE SMOKE. ACCELERATOR TOP COVER HAD VISIBLE SMOKE AND FIRE DAMAGE. THE FIRE DEPARTMENT REQUESTED REMOVAL OF COVER TO EVALUATE ANY HOT-SPOTS. USE OF AN INFRARED CAMERA REVEALED THAT THE UNIT CIRCUIT BOARD IN QUESTION WAS SHOWING SIGNS OF COOLING. THE FIRE MARSHALL INVESTIGATED UNIT IN CONJUNCTION WITH FACILITY BIO-MEDICAL ENGINEERS. AFTER EVALUATION OF THE ACCELERATOR WITH THE FIRE MARSHALL, THE ROOM WAS CLEARED AS A FIRE SCENE. INDUSTRIAL HYGIENIST WAS SUMMONED TO PERFORM AIR QUALITY TESTING WITHIN 1 HOUR OF THE EVENT. OVERNIGHT TESTING WAS REPEATED. MANUFACTURER, VARIAN, WAS NOTIFIED BY THE FACILITY OF THE INCIDENT AT AROUND 9:35 AM AND IT REQUESTED LOCAL FIELD SERVICE COME TO EXAMINE THE UNIT. THE FACILITY INSTRUCTED THE MANUFACTURER FIELD REP THAT HE COULD VISUALLY INSPECT BUT NOT SERVICE, REMOVE OR REPAIR COMPONENTS UNTIL BIOMED APPROVES. THE VENDOR FIELD SERVICE ENGINEER CAME AROUND 12 NOON AND INSPECTED THE UNIT. THE UNIT HAS BEEN SEQUESTERED.====================== MANUFACTURER RESPONSE FOR RADIATION LINEAR ACCELERATOR, VARIAN CLINAC======================MANUFACTURER IS ASSEMBLING A REPLACEMENT PART LISTS. THERE IS ADDITIONAL ANALYSIS THAT WILL BE DONE ONCE THE UNIT IS RELEASED TO THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VARIAN CLINAC LINEAR ACCELERATOR, RADIATION THERAPY IYE VARIAN MEDICAL SYSTEMS, INC. 2100 CD *

    Patients

    Seq Age Sex Outcome Treatment
    1 *