BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VARIAN 2100EX

    MDR report key: 1631804 · Received March 10, 2010

    Report

    Report Number
    MW5015116
    Event Type
    Injury
    Date Received
    March 10, 2010
    Date of Event
    February 16, 2010
    Report Date
    March 10, 2010
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC
    Product Code
    IYE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS IDENTIFIED THAT 12 FRACTIONS OF A RADIATION COURSE OF THERAPY DID NOT HAVE THE PLANNED BLOCKING ON 2 OF 14 TREATMENT FIELDS. TREATMENTS OCCURRED BETWEEN (B) (6) 2010 AND (B) (6) 2010. OVEREXPOSURE OCCURRED ON 2 OF 14 FIELDS EACH OF THE 12 DAYS. CMS TREATMENT PLANNING SYSTEM AND RTP EXCHANGE WHICH IS A DATA TRANSFER PROGRAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VARIAN 2100EX VARIAN LINEAR ACCELERATOR IYE VARIAN MEDICAL SYSTEMS, INC 2100EX SD

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other