BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOGRAPH LSO DUO

    MDR report key: 947956 · Received September 2, 2004

    Report

    Report Number
    1034973-2004-00005
    Event Type
    Malfunction
    Date Received
    September 2, 2004
    Date of Event
    July 1, 2004
    Report Date
    July 16, 2004
    Manufacturer
    CTI PET SYSTEMS, INC.
    Product Code
    KPS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOGRAPH LSO DUO PET/CT SCANNER KPS CTI PET SYSTEMS, INC. 3600214-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other