BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIO RTP SYSTEM

    MDR report key: 494131 · Received November 3, 2003

    Report

    Report Number
    1937649-2003-00008
    Event Type
    Malfunction
    Date Received
    November 3, 2003
    Date of Event
    October 27, 2003
    Report Date
    November 3, 2003
    Manufacturer
    COMPUTERIZED MEDICAL SYSTEMS, INC.
    Product Code
    MUJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS IS A DUPLICATE OF MDR

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIO RTP SYSTEM RADIATION TREATMENT PLANNING SYSTEM MUJ COMPUTERIZED MEDICAL SYSTEMS, INC. ALL RELEASES 4.0.0 TRHOUGH 4.1.1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA