BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VARIAN

    MDR report key: 2450237 · Received February 8, 2012

    Report

    Report Number
    MW5024216
    Event Type
    Malfunction
    Date Received
    February 8, 2012
    Date of Event
    February 3, 2012
    Report Date
    February 8, 2012
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Product Code
    IYE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    COMMUNICATION WAS LOST BETWEEN THE RECORD AND VERIFY SYSTEM AND THE TREATMENT MACHINE. THE TREATMENT HAD TO BE MANUALLY RECORDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR