BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONACO

    MDR report key: 7008658 · Received November 8, 2017

    Report

    Report Number
    1937649-2017-00006
    Event Type
    Malfunction
    Date Received
    November 8, 2017
    Report Date
    November 22, 2017
    Manufacturer
    ELEKTA INC
    Product Code
    MUJ
    UDI-DI
    00858164002169
    PMA / PMN Number
    K151233
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SI
    Reporter Occupation
    PHYSICIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER'S INVESTIGATION IS ON-GOING AND FURTHER INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS COMPLETED.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION WAS COMPLETED BY CONDUCTING A THOROUGH EVALUATION OF THE PRODUCT AND THE REPORTED INFORMATION. THE ISSUE WAS DETERMINED TO BE A DEFECT IN THE PRODUCT AND WILL BE FIXED IN A LATER VERSION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT MONACO WILL DISPLAY THE WRONG MU OR DOSE VALUE ON PRESCRIPTION UI FOR A 3D PLAN. BASED ON THE AVAILABLE INFORMATION THERE HAS BEEN NO MISTREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788245 MONACO SYSTEM, PLANNING, RADIATION THERAPY TREATMENT MUJ ELEKTA INC 00858164002169

    Patients

    Seq Age Sex Outcome Treatment
    1