BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONACO RTP SYSTEM

    MDR report key: 3631895 · Received January 10, 2014

    Report

    Report Number
    1937649-2014-00001
    Event Type
    Injury
    Date Received
    January 10, 2014
    Report Date
    January 10, 2014
    Manufacturer
    IMPAC MEDICAL SYSTEMS, INC.
    Product Code
    MUJ
    PMA / PMN Number
    K110730
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS TREATED WITH BOLUS; HOWEVER, THE PLAN DID NOT INCLUDE BOLUS. THIS INCIDENT RESULTED IN A DOSE DIFFERENCE THAT IS PRESUMED TO RESULT IN SERIOUS INJURY. PATIENT'S STATUS IS UNKNOWN. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20721 MONACO RTP SYSTEM RADIATION TREATMENT PLANNING SYSTEM MUJ IMPAC MEDICAL SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other