BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOGRAPH LSO DUO

    MDR report key: 739846 · Received June 29, 2005

    Report

    Report Number
    1034973-2005-00005
    Event Type
    Malfunction
    Date Received
    June 29, 2005
    Date of Event
    April 12, 2005
    Report Date
    April 20, 2005
    Manufacturer
    CTI PET SYSTEMS, INC.
    Product Code
    KPS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INTERMITTENTLY, THE VERTICAL BED HEIGHT DISPLAYED IN THE PET SINOGRAM HEADERS IS INCORRECT. AS A RESULT OF THIS, PET IMAGES ARE NOT PROPERLY ATTENUATION CORRECTED. THIS IS THE RESULT OF THE PET DATA BEING ATTENUATION CORRECTED WITH A CT DATA SET THAT HAS A DIFFERENT VERTICAL BED HEIGHT THAN THE PET DATA. ADDITIONALLY, BECAUSE OF PET AND CT DATA SETS HAVE DIFFERENT VERTICAL BED HEIGHTS, THE DATA WILL NOT REGISTER PROPERLY IN THE DISPLAY SOFTWARE. THIS PROBLEM COULD POTENTIALLY CAUSE THE END USER TO MISREAD THE IMAGE. NO INJURIES HAVE BEEN REPORTED TO CPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOGRAPH LSO DUO PET/CT SCANNER KPS CTI PET SYSTEMS, INC. P0006733 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other