BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINAC

    MDR report key: 2190650 · Received July 27, 2011

    Report

    Report Number
    2916710-2011-00096
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 28, 2011
    Report Date
    July 1, 2011
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Product Code
    IYE
    PMA / PMN Number
    K100890
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THERE WAS NO REPORTED INJURY IN THIS CASE, THE AVAILABLE INFORMATION SUGGESTS A POSSIBLE MALFUNCTION OF THE DEVICE. THOUGH STILL UNDER INVESTIGATION, VARIAN HAS DETERMINED THAT A MDR IS APPROPRIATE AS THIS POSSIBLE MALFUNCTION, SHOULD IT RECUR, COULD POTENTIALLY CAUSE SERIOUS INJURY. ADDITIONAL FOLLOW-UP TO THIS MDR IS EXPECTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE THERAPIST NOTICED THAT THE FIELD SIZE DID NOT MATCH THE PLAN, AND THAT THE CLINAC DID NOT GIVE ANY INTERLOCKS. THE THERAPIST REPORTED THAT THE PATIENT COULD HAVE BEEN TREATED, HAD THE THERAPIST NOT PAID ATTENTION. THE 4DTC FIELD SIZE VALUES WERE NOT MATCHING THE PLAN, BUT THE CLINAC SCREEN ONLY HAD KEY INTERLOCK REMAINING. A VARIAN FIELD SERVICE REPRESENTATIVE (FSE) REMAINED ON SITE TO MONITOR BUT COULD NOT REPRODUCE THE ISSUE. THE CUSTOMER SITE STATED THAT IT IS VERY INTERMITTENT. THERE WAS NO SERIOUS INJURY REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINAC ACCELERATOR, LINEAR, MEDICAL IYE VARIAN MEDICAL SYSTEMS, INC. H14

    Patients

    Seq Age Sex Outcome Treatment
    1