BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOGRAPH LSO DUO

    MDR report key: 796562 · Received December 10, 2004

    Report

    Report Number
    1034973-2004-00006
    Event Type
    Malfunction
    Date Received
    December 10, 2004
    Date of Event
    November 9, 2004
    Report Date
    November 10, 2004
    Manufacturer
    CTI PET SYSTEMS, INC.
    Product Code
    KPS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIST

    Narratives

    Additional Manufacturer Narrative · 1

    CPS IS CURRENTLY TESTING A BETA PATCH THAT WILL RESOLVE THIS ISSUE. ONCE ALL TESTING IS COMPLETED, A PATCH WILL BE RELEASED TO ALL AFFECTED SITES TO CORRECT THIS PROBLEM AND PREVENT IT FROM RECURRING.

    Description of Event or Problem · 1

    INTERMITTENTLY, THE VERTICAL BED HEIGHT DISPLAYED IN THE PET SINOGRAM HEADERS IS INCORRECT. AS A RESULT OF THIS, THE ATTENUATION CORRECTED PET DATA WILL CONTAIN ARTIFACTS. 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 SET. ADDITIONALLY, BECAUSE THE 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. 3600214-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other