BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONACO

    MDR report key: 5106106 · Received September 25, 2015

    Report

    Report Number
    1937649-2015-00018
    Event Type
    Injury
    Date Received
    September 25, 2015
    Report Date
    November 19, 2020
    Manufacturer
    ELEKTA INC.
    Product Code
    MUJ
    PMA / PMN Number
    K151233
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION WAS COMPLETED BY CONDUCTING A THOROUGH EVALUATION OF THE PRODUCT AND THE REPORTED INFORMATION. IT WAS DETERMINED THAT PRODUCT WORKS AS DESIGNED AND INTENDED. THE DELIVERED TREATMENT PLAN WAS DERIVED FROM A CALCULATION PERFORMED USING AN INCORRECT BEAM MODEL WITH INCORECT WEDGE MU. RESUBMITTING FORM 3500A DUE TO AN ADMINISTRATIVE ERROR. IT WAS REQUESTED BY FDA MEDWATCH PROGRAM DEPARTMENT TO RE-SUBMIT THE INITIAL REPORT AS THERE WAS NO RECORD OF INITIAL REPORT SUBMISSION IN EMDR SYSTEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER IS SEEING A 25% MU ERROR FOR 60 DEGREE WEDGED PLANS WITH THE CC MODEL. BASED ON THE AVAILABLE INFORMATION, 9 PATIENTS WERE TREATED INCORRECTLY, OF WHICH 7 PATIENTS RECEIVED AN UNDERDOSE RANGING FROM 3% - 19%, AND 2 PATIENTS RECEIVED AN OVERDOSE OF 7%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637252 MONACO SYSTEM,PLANNING,RADIATION THERAPY TREATMENT MUJ ELEKTA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other