BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARIA RADIATION ONCOLOGY

    MDR report key: 2031480 · Received March 18, 2011

    Report

    Report Number
    2916710-2011-00023
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 22, 2011
    Report Date
    February 22, 2011
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Product Code
    IYE
    PMA / PMN Number
    K093527
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THERE WAS NO REPORTED INJURY IN THIS CASE, THE AVAILABLE INFO SUGGESTS A POSSIBLE MALFUNCTION OF THE DEVICE. THOUGH STILL UNDER INVESTIGATION, VARIAN HAS DETERMINED THAT AN 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

    CUSTOMER REPORTS THAT AFTER FILLING OUT THE DETAILS INSIDE THE PHYSICIAN INTENT WINDOW AND SELECTING OK, IF AFTERWARDS YOU GO TO THE MAIN SCREEN AND CHANGE THE PLANNED NUMBER OF FRACTIONS IN THE "PHYSICIAN'S INTENT" SECTION BY TYPING IN THE NEW VALUE USING THE KEYBOARD, THE SYSTEM ENTERS THE NUMBERS IN REVERSE; E.G. IF THE NEW VALUE 12 IS TYPED, IT IS ENTERED AS 21.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1