BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONACO

    MDR report key: 7234008 · Received February 1, 2018

    Report

    Report Number
    1937649-2018-00008
    Event Type
    Injury
    Date Received
    February 1, 2018
    Report Date
    February 1, 2018
    Manufacturer
    ELEKTA INC.
    Product Code
    MUJ
    PMA / PMN Number
    K151233
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION WAS COMPLETED BY CONDUCTING A THOROUGH EVALUATION OF THE PRODUCT AND THE REPORTED INFORMATION. (B)(4) HAVE BEEN UNABLE TO REPRODUCE THE REPORTED ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WRONG DOSE-MU IN SEGMENTED 3D PLAN. BASED ON THE AVAILABLE INFORMATION THERE HAS BEEN AN ACTUAL MISTREATMENT WHICH HAS LED TO SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78319 MONACO SYSTEM,PLANNING,RADIATION THERAPY TREATMENT MUJ ELEKTA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other