BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARIA RADIATION ONCOLOGY

    MDR report key: 2234341 · Received July 21, 2011

    Report

    Report Number
    2916710-2011-00091
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 23, 2011
    Report Date
    June 23, 2011
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC
    Product Code
    IYE
    PMA / PMN Number
    K093527
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 USER REPORTS THAT THEY ARE UNABLE TO SEE FIDUCIAL STRUCTURE WITHIN OLR HOWEVER, ONE CAN SEE THE LAYER CREATED IN RTC AND ALSO ONE CAN SEE THE STRUCTURE WITHIN EC. CUSTOMER DESELECTED THE STRUCTURE AND RESELECTED HOWEVER THIS DID NOT RE-ACTIVATE IT. THERE WAS NO REPORT OF SERIOUS INJURY AS A RESULT OF THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARIA RADIATION ONCOLOGY ACCELERATOR, LINEAR, MEDICAL IYE VARIAN MEDICAL SYSTEMS, INC HRO

    Patients

    Seq Age Sex Outcome Treatment
    1