BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINAC

    MDR report key: 1894273 · Received November 4, 2010

    Report

    Report Number
    2916710-2010-00124
    Event Type
    Malfunction
    Date Received
    November 4, 2010
    Date of Event
    June 15, 2010
    Report Date
    September 20, 2010
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    IYE
    PMA / PMN Number
    K070094
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THOUGH STILL UNDER INVESTIGATION, VARIAN HAS DETERMINED THAT A MDR IS APPROPRIATE, AS THIS EVENT, SHOULD IT RECUR, COULD POTENTIALLY CAUSE A SERIOUS INJURY. ADDITIONAL FOLLOW-UP TO THIS MDR IS EXPECTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    VARIAN RECEIVED A REPORT THAT WAS PUBLISHED IN A TRINIDAD NEWSPAPER INVOLVING THE MINISTRY OF HEALTH AND CLINAC LINEAR ACCELERATOR. THE REPORT ALLEGES THAT THE "CENTRE'S LINEAR ACCELERATOR WAS, OVER A PERIOD OF MONTHS, POSSIBLY ADMINISTERING UP TO 20 PERCENT MORE RADIATION THAN WAS NECESSARY TO CLIENTS BEING TREATED FOR CANCER." IN ADDITION, IT WAS REPORTED, "THAT ONE OF THE INSTRUMENTS USED, AN ELECTROMETER, WAS FOUND TO BE POSSIBLY FAULTY." NO PT DATA HAS BEEN SUBMITTED TO VARIAN IDENTIFYING PT MISADMINISTRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINAC LINEAR ACCELERATOR IYE VARIAN MEDICAL SYSTEMS H29

    Patients

    Seq Age Sex Outcome Treatment
    1