BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONACO

    MDR report key: 6198322 · Received December 22, 2016

    Report

    Report Number
    1937649-2016-00014
    Event Type
    Malfunction
    Date Received
    December 22, 2016
    Report Date
    December 22, 2016
    Manufacturer
    IMPAC MEDICAL SYSTEMS, INC.
    Product Code
    MUJ
    UDI-DI
    00858164002152
    PMA / PMN Number
    K151233
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SI
    Reporter Occupation
    PHYSICIST

    Narratives

    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. IFSN 382-01-MON-009 WILL BE ISSUED TO AFFECTED CUSTOMERS - SCHEDULED FOR RELEASE JAN-2017. THIS PROBLEM WILL BE RESOLVED IN PATCHES TO THE FOLLOWING (B)(6)RELEASES (SCHEDULED FOR RELEASE JUN-2017) : 5.10, 5.11, 5.30.00 ((B)(6) SITES ONLY).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PATIENT HAS RECEIVED THE FIRST FRACTION OF THE TREATMENT BEFORE REALISING THAT THE WRONG DOSE WAS CALCULATED IN (B)(6). BASED ON THE AVAILABLE INFORMATION THERE HAS BEEN AN ACTUAL MISTREATMENT, HOWEVER THE SEVERITY DID NOT LEAD TO SERIOUS CLINICAL OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847943 MONACO SYSTEM,PLANNING,RADIATION THERAPY TREATMENT MUJ IMPAC MEDICAL SYSTEMS, INC. 00858164002152

    Patients

    Seq Age Sex Outcome Treatment
    1