BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOGRAPH SENSATION 16

    MDR report key: 560861 · Received May 13, 2004

    Report

    Report Number
    1034973-2004-00003
    Event Type
    Malfunction
    Date Received
    May 13, 2004
    Date of Event
    March 3, 2004
    Report Date
    April 13, 2004
    Manufacturer
    CTI PET SYSTEMS, INC.
    Product Code
    KPS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS SOFTWARE PROBLEM WAS IDENTIFIED IN THE MULTISERIES VIEWER SOFTWARE (MSV). WHEN A SECOND CT SCAN IS PERFORMED AFTER A WHOLE BODY PET/CT SCAN, THE SECOND CT DATA SET WILL BE MISALIGNED WITH THE PET DATA SET BECAUSE THE 2 DATA SETS (THE CT DATA SET AND THE PET DATA SET) ARE FUSED TOGETHER BASED ON THE CENTER POINT OF EACH SET. THIS MISALIGNMENT PRODUCES AN INCORRECT FUSED DATA SET. DEPENDING ON THE RANGE OF THE SECOND CT, THE MISALIGNMENT IS EITHER VERY OBVIOUS, OR IT IS VERY DIFFICULT TO DETECT. FOR EXAMPLE, IF THE SECOND CT SCAN IS PERFORMED ON A SMALLER AREA OF THE BODY, THE DIFFERENCE WILL BE VERY NOTICEABLE BECAUSE THE CENTER OF THE SMALLER CT DATA SET AND THE CENTER OF THE LARGER WHOLE BODY PET DATA SET WILL BE SIGNIFICANTLY DIFFERENT. WHEN THE TWO DATA SETS ARE FUSED, THIS WILL PRODUCT A DATE SET THAT IS OBVIOUSLY INCORRECT. HOWEVER, IF THE SECOND CT DATA SET IS PERFORMED OVER A LARGER AREA OF THE BODY, AND FUSED WITH THE BODY PET DATA SET THE MISALIGNMENT IS MUCH MORE DIFFICULT TO DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOGRAPH SENSATION 16 PET/CT SCANNER KPS CTI PET SYSTEMS, INC. 3600216-00 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other