BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINEAR ACCELERATOR

    MDR report key: 11420 · Received February 10, 1994

    Report

    Report Number
    MW1000701
    Event Type
    Malfunction
    Date Received
    February 10, 1994
    Date of Event
    January 12, 1994
    Manufacturer
    VARIAN ASSOC, INC.
    Product Code
    IYE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    HOSPITAL SERVICE TECHNICIAN

    Narratives

    Description of Event or Problem · 1

    RPTR NOTICED IN LATERAL TREATMENT USING ISOCENTRIC TECHNIQUE, THE FIELD MOVED 0.7 CM. THIS ERROR WAS NOT CONSTANT AND COULD BE VERY DANGEROUS PRODUCING DAMAGE TO THE SPINAL CORD. (RADIATION MYELITIS). THERE WAS PLAY FOUND IN THE ACCESSORY TRAY TO COLLIMATOR FACE AND IN THE BLOCK TRAY HOLDER ITSELF. THE BLOCK TRAY HOLDER PROBLEM WAS DUE TO THE SPRING PIN WHICH HOLDS UP THE BLACK TRAY. THIS WAS CORRECTED BY REMOVING THE SPRING PINS AND ADDING A MORE SOLID MATERIAL TO THE BLOCK TRAY RELEASE ARM (SILVER SOLDER). THE RELEASE ARM WAS REMACHINED TO REDUCE PLAY. THE END RAIL PLATES ON THE ACCESSORY TRAY WERE ALSO SHIMMED TO REDUCE PLAY IN THE ACCESSORY TRAY TO COLLIMATOR FACE. THE CONCERN HERE IS THAT THERE WAS NO WARNING FROM MFR. RPTR RECOMMENDS THIS MAY REQUIRE: FURTHER EVAL OF ENGINEERING DESIGN, WARNING TO OTHER USERS, POSSIBLE RECALL AND REPAIR TO PREVENT FURTHER PROBLEMS AND WEEKLY QUALITY CONTROL CHECK OF BLOCKS FOR DISPLACEMENT DUE TO THEIR OWN WEIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINEAR ACCELERATOR IYE VARIAN ASSOC, INC. VARIAN 6-100

    Patients

    Seq Age Sex Outcome Treatment
    1 NA