BEUDAMED
    FDA Adverse Event Other Summary report: N

    BRACHYVISION

    MDR report key: 3037693 · Received March 28, 2013

    Report

    Report Number
    3003793371-2013-00002
    Event Type
    Other
    Date Received
    March 28, 2013
    Date of Event
    January 1, 2013
    Report Date
    March 28, 2013
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Product Code
    MUJ
    PMA / PMN Number
    K992762
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED ON INFORMATION RECEIVED FROM A THIRD PARTY OR DEVELOPED BY VARIAN MEDICAL SYSTEMS.

    Description of Event or Problem · 1

    THE CUSTOMER USED BRACHYVISION VERSION 7.3.10 O CREATE INTERSTITIAL TREATMENT PLANS FOR 7 PTS WITH DIFFERENT TREATMENT SITES (INCLUDING NASOPHARYNX AND BASE OF TONGUE). DUE TO A MISUNDERSTANDING OF THE FRACTIONATION CONCEPT OF BRACHYVISION ALL 7 PTS WERE UNDERDOSED. FOR EXAMPLE, THEY PLANNED FOR 10 FRACTIONS WITH A TOTAL DOSE OF 35 GY BUT DELIVERED ONLY 0.35 GY PER FRACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129616 BRACHYVISION SYSTEM, PLANNING, RADIATION THERAPY TRMT MUJ VARIAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other