BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MRIDIAN

    MDR report key: 5522436 · Received March 24, 2016

    Report

    Report Number
    3007546534-2016-00002
    Event Type
    Malfunction
    Date Received
    March 24, 2016
    Date of Event
    February 25, 2016
    Report Date
    March 23, 2016
    Manufacturer
    VIEWRAY, INCORPORATED
    Product Code
    IYE
    PMA / PMN Number
    K111862
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    VIEWRAY RECEIVED A REPORT THAT THEY EDITED A RE-OPTIMIZED PLAN, MOVED THE ISOCENTER, AND SUSPECTED THAT THEY WOULD BE ALLOWED TO PROCEED TO TREATMENT WITHOUT BEING FORCED TO APPLY A COUCH SHIFT TO MOVE THE PATIENT TO THE NEW ISOCENTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180756 MRIDIAN RADIATION THERAPY SYSTEM IYE VIEWRAY, INCORPORATED 10000

    Patients

    Seq Age Sex Outcome Treatment
    1