BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MRIDIAN SYSTEM

    MDR report key: 5389986 · Received January 25, 2016

    Report

    Report Number
    3007546534-2016-00001
    Event Type
    Malfunction
    Date Received
    January 25, 2016
    Date of Event
    December 24, 2015
    Report Date
    January 20, 2016
    Manufacturer
    VIEWRAY, INCORPORATED
    Product Code
    IYE
    PMA / PMN Number
    K111862
    Removal / Correction Number
    300754653401112016001C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    VIEWRAY RECEIVED A REPORT THAT THE SOFTWARE LOADED THE TREATMENT COMPLETION PLAN INTO THE DELIVERY WORKFLOW IN AN UNEXPECTED ORDER. WHEN A COMPLETION PLAN IS MOVED TO A LATER POSITION IN THE DELIVERY CALENDAR AND ANOTHER TREATMENT INTERRUPTION OF A SUBSEQUENT FRACTION OCCURS THE SOFTWARE LOADS THE COMPLETION PLAN IN AN ORDER THAT THE USER MAY NOT EXPECT. NO REPORTS OF TREATMENT IN AN INCORRECT ORDER OR INJURY HAS BEEN REPORTED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47551 MRIDIAN SYSTEM RADIATION THERAPY SYSTEM IYE VIEWRAY, INCORPORATED 10000 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1