BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICAL GUIDANCE PLATFORM

    MDR report key: 2432811 · Received January 10, 2012

    Report

    Report Number
    2916710-2011-00152
    Event Type
    Malfunction
    Date Received
    January 10, 2012
    Date of Event
    December 12, 2011
    Report Date
    December 13, 2011
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Product Code
    IYE
    PMA / PMN Number
    K071360
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. VARIAN HAS DETERMINED THAT A MDR IS APPROPRIATE, AS THIS SITUATION, SHOULD IR RECUR, COULD POTENTIALLY RESULT IN SERIOUS INJURY. ADDITIONAL FOLLOW-UP TO THIS MDR IS EXPECTED UPON COMPLETION OF THE INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER USING THE ADAC PINNACLE TREATMENT PLANNING SYSTEM WITH THE VARIAN OPTICAL GUIDANCE PLATFORM HAS REPORTED THAT ISOCENTER COORDINATES TRANSMITTED FROM THE CUSTOMER TREATMENT PLANNING SYSTEM ARE BEING ALTERED BY A SIGN CHANGE. THIS PROBLEM IS INTERMITTENT. THERAPISTS ARE CHECKING THE ISOCENTER ON EVERY PATIENT AT TIME OF TREATMENT. MANUAL ALTERATIONS ARE MADE AS NEEDED. NO REPORT OF INJURY HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTICAL GUIDANCE PLATFORM ACCELERATOR, LINEAR, MEDICAL IYE VARIAN MEDICAL SYSTEMS, INC. HZ10

    Patients

    Seq Age Sex Outcome Treatment
    1