BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIO RTP SYSTEM

    MDR report key: 506068 · Received December 3, 2003

    Report

    Report Number
    1937649-2003-00009
    Event Type
    Malfunction
    Date Received
    December 3, 2003
    Date of Event
    October 17, 2003
    Report Date
    December 3, 2003
    Manufacturer
    COMPUTERIZED MEDICAL SYSTEMS, INC.
    Product Code
    MUJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    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 RLEASES 4.0.0 THROUGH 4.1.1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA