BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINAC

    MDR report key: 1760676 · Received July 14, 2010

    Report

    Report Number
    2916710-2010-00074
    Event Type
    Malfunction
    Date Received
    July 14, 2010
    Date of Event
    June 16, 2010
    Report Date
    June 17, 2010
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    IYE
    PMA / PMN Number
    K061140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIST

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MODEL #H29. ALTHOUGH THERE WAS NO REPORTED INJURY IN THIS CASE, THE AVAILABLE INFORMATION SUGGESTS A MALFUNCTION IN THE DEVICE. VARIAN HAS DETERMINED THAT AN MDR IS APPROPRIATE, AS THIS MALFUNCTION CREATES AN ELECTRICAL HAZARD AND, SHOULD IT RECUR, COULD POTENTIALLY CAUSE A SERIOUS INJURY. THE PART WAS REPLACED AND THE DEVICE RETURNED TO NORMAL OPERATION. THIS ISSUE HAS BEEN REFERRED TO VARIAN'S CAPA PROGRAM FOR FURTHER INVESTIGATION. NO ADDITIONAL FOLLOW UP IS ANTICIPATED AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED WATER LEAKS ON THE KLYSTRON SOLENOID RETURN AND SUPPLY HOSE (B)(4) - 00 1/2 INCH FITTING. THERE WAS NO REPORT OF ANY INJURY TO A PATIENT OR THE USER AND NO PATIENT INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1