BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINAC

    MDR report key: 1970157 · Received January 14, 2011

    Report

    Report Number
    2916710-2010-00160
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 30, 2010
    Report Date
    December 30, 2010
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Product Code
    IYE
    PMA / PMN Number
    K904364
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A VARIAN SERVICE TECHNICIAN PUT THE COVER BACK ONTO THE MACHINE AND VERIFIED IT WAS SECURE FUNCTIONING PROPERLY. VARIAN'S INVESTIGATION REVEALED THAT DURING TREATMENT, THE CENTER THROAT COVER (FIBERGLASS COVER) IS AT ITS LONGEST WHEN THE GANTRY ANGLE IS AT EITHER 90 DEGREES OR 270 DEGREES, SHADOWING OVER THE PT. A LOOSE OR INCORRECTLY APPLIED FASTENER WOULD ENABLE THE LATCHING MECHANISMS TO FAIL, ALLOWING THE THROAT COVER TO FALL ONTO THE PT. THE FIBERGLASS COVER WEIGHS APPROXIMATELY 17 LBS, THE CENTER OF THE COVER IS AT ISO-CENTER (CLOSE TO THE LEVEL OF THE PT) AND THE PART OF THE COVER THAT COULD HIT THE PT IS A FLAT, SMOOTH SURFACE. THE HAZARD ANALYSIS DETERMINED THAT IF THIS SCENARIO OCCURRED, IT COULD CAUSE A SUPERFICIAL CUT AND/OR BRUISE TO THE PT'S HEAD. VARIAN HAS PREVIOUSLY PROVIDED A CUSTOMER TECHNICAL BULLETIN TO ELABORATE ON HOW TO LATCH THE CENTER THROAT COVER PROPERLY. IN ADDITION, A DESIGN IMPROVEMENT TO THE LATCHING MECHANISM WAS CUT-IN TO MANUFACTURING IN AUGUST 2006. THE FIBERGLASS COVER WAS REPLACED AND REINSTALLED AT THIS SITE. FURTHER ACTIONS WILL BE ADDRESSED IN VARIAN'S CAPA PROCESS. NO ADDITIONAL FOLLOW-UP TO THIS MDR IS ANTICIPATED.

    Description of Event or Problem · 1

    WHILE PT WAS BEING TREATED, THE THROAT COVER FELL OFF THE MACHINE AND THE PT WAS STRUCK IN THE HEAD. THE DOCTOR REPORTED THAT THE PT WAS NOT INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINAC LINEAR ACCELERATOR IYE VARIAN MEDICAL SYSTEMS, INC. 2100C/D

    Patients

    Seq Age Sex Outcome Treatment
    1