BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONACO RTP SYSTEM

    MDR report key: 2887368 · Received December 21, 2012

    Report

    Report Number
    1937649-2012-00001
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    October 11, 2012
    Report Date
    December 21, 2012
    Manufacturer
    IMPAC MEDICLA SYSTEMS, INC.
    Product Code
    MUJ
    PMA / PMN Number
    K110730
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT REPORTED IS BEING INVESTIGATED. A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PT UNDERWENT RADIOTHERAPY TREATMENT PLANNING USING THE MONACO SYSTEM. CUSTOMER PLANNED PT AS SETUP TO BE HEAD FIRST SUPINE; HOWEVER, THE PT WAS TREATED FEET FIRST SUPINE FOR THE ENTIRE TREATMENT. DETAILS OF THE TREATMENT ARE FOLLOWED: TWO PLANNING TARGET VOLUMES (PTV). PT WAS SIMULATED (B)(6) 2012 AND 1ST FRACTION WAS DELIVERED (B)(6) 2012. FIRST PTV: FULL 4500 CGY IN 25 FRACTIONS BY PLAN WENT IN FEET FIRST. SECOND PTV: 1620 CGY OF A PLANNED 3600 CGY IN 9 FRACTIONS BY PLAN WENT IN FEET FIRST. THE RESULT WAS A FLIPPED FIELD GEOMETRY THAT SIGNIFICANTLY UNDERDOSED TARGETED VOLUMES AND SIGNIFICANTLY OVERDOSED NON-TARGETED TISSUE. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONACO RTP SYSTEM MONACO RTP SYSTEM MUJ IMPAC MEDICLA SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other