BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONACO

    MDR report key: 7044532 · Received November 20, 2017

    Report

    Report Number
    1937649-2017-00008
    Event Type
    Injury
    Date Received
    November 20, 2017
    Report Date
    November 20, 2017
    Manufacturer
    IELEKTA INC
    Product Code
    MUJ
    PMA / PMN Number
    K151233
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION WAS COMPLETED BY CONDUCTING A THOROUGH EVALUATION OF THE PRODUCT AND THE REPORTED INFORMATION. ACCORDING TO THE PLAN DATA PROVIDED BY THE SITE, THE PLAN WAS DELIVERED AND CALCULATED AS PRESCRIBED. THE NATURE OF THE PROBLEM COULD NOT BE CONFIRMED WITH THE DATA PROVIDED BY THE SITE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED RESCALE LOST AFTER REMOVING SETUP FIELDS. BASED ON THE AVAILABLE INFORMATION THE CUSTOMER REPORTED A PATIENT WAS MISTREATED AND RECEIVED A DOSE THAT WAS 14% HIGHER THAN INTENDED. ALL FRACTIONS WERE DELIVERED AND THE ISSUE WAS NOT DISCOVERED UNTIL THE PATIENT'S TREATMENT HAD COMPLETED. THE PATIENT HAS BEEN TREATED FOR OESOPHAGITIS SINCE COMPLETING THE COURSE OF TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823683 MONACO SYSTEM,PLANNING,RADIATION THERAPY TREATMENT MUJ IELEKTA INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other