BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY DELIVERY SYSTEM

    MDR report key: 3901551 · Received June 13, 2014

    Report

    Report Number
    3901551
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    March 3, 2014
    Report Date
    June 13, 2014
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Product Code
    IYE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MALE PATIENT WITH UT3 N1 M0 MODERATELY DIFFERENTIATED INVASIVE RECTAL CARCINOMA WAS UNDERGOING ADJUVANT RADIOTHERAPY TO TREAT HIS TUMOR PRIOR TO LOW ANTERIOR RESECTION. PATIENT PLACED ON BELLY BOARD. TREATED THE POSTERIOR-ANTERIOR (PA), RIGHT AND LEFT LATERAL FIELDS. PLANNED TO TREAT THE ANTERIOR-POSTERIOR (AP) FIELD. NOTICED THE TABLE HAD SHIFTED FROM THE TREATMENT POSITION THAT THEY HAD SET UP. REALIGNED THE PATIENT AND TREATED THE ANTERIOR-POSTERIOR (AP) FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350652 TRILOGY DELIVERY SYSTEM ACCELERATOR, LINEAR, MEDICAL IYE VARIAN MEDICAL SYSTEMS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR