BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4D INTEGRATED TREATMENT CONSOLE

    MDR report key: 2141330 · Received June 1, 2011

    Report

    Report Number
    2916710-2011-00062
    Event Type
    Malfunction
    Date Received
    June 1, 2011
    Date of Event
    May 4, 2011
    Report Date
    May 4, 2011
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Product Code
    IYE
    PMA / PMN Number
    K091132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT THEY HAD A PT ON THE TABLE READY TO TREAT. THEY MODED UP THE FIRST FIELD, WHICH CALLS FOR A GANTRY ANGLE OF 264 AND A WEDGE. THEY NOTICED THAT THE MACHINE WENT INSTEAD TO GANTRY ANGLE 92 AND THEY HADN'T YET PUT THE WEDGE IN, AND THE 4DITC DID NOT HIGHLIGHT EITHER OF THESE ITEMS IN ORANGE, SO THEY FELT THAT THE 4DTIC WAS GOING TO ALLOW THEM TO TREAT WITH THE WRONG VALUES. THERE WAS NO MISADMINISTRATION OR SERIOUS INJURY REPORTED ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4D INTEGRATED TREATMENT CONSOLE ACCELERATOR, LINEAR, MEDICAL IYE VARIAN MEDICAL SYSTEMS, INC. H51

    Patients

    Seq Age Sex Outcome Treatment
    1