BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEVION S250

    MDR report key: 6202289 · Received December 23, 2016

    Report

    Report Number
    3007087027-2016-00003
    Event Type
    Malfunction
    Date Received
    December 23, 2016
    Date of Event
    November 22, 2016
    Report Date
    December 23, 2016
    Product Code
    LHN
    PMA / PMN Number
    K120676
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    THIS NOTIFICATION REPORTS A MALFUNCTION AND ADVERSE EVENT. A SOFTWARE ERROR HAS BEEN IDENTIFIED WHEREIN PATIENT POSITION CORRECTIONS ARE LOST WHEN USING MULTIPLE SETUP FIELD PLANS TO TREAT AT MULTIPLE ISOCENTERS IN SEQUENCE RESULTING IN LOST DELTAS WHEN CLOSING A SETUP FIELD. A SOFTWARE ERROR OR OTHER USER CONDITION CAN OCCUR IN THE FEW MILLISECONDS AFTER THE FIRST SETUP FIELD IS CLOSED AND BEFORE THE INFORMATION IS COMMUNICATED BACK TO THE RECORD AND VERIFY SYSTEM. ONE MISTREATMENT OCCURRED WHEREBY A SINGLE TREATMENT FRACTION WAS DELIVERED APPROXIMATELY 3 CM FROM THE TARGET AREA. THE SINGLE TREATMENT WAS MORE THAN 2 CM FROM THE PRESCRIBED FIELD EDGE, THUS MEETING THE DEFINITION OF A "SERIOUS INJURY". THE PRODUCT SOFTWARE SHALL BE UPDATED TO RESOLVE THE ISSUE AND PREVENT RECURRENCE OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853275 MEVION S250 PROTON THERAPY DEVICE LHN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other