BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECEDENCE SPECT/CT

    MDR report key: 914706 · Received September 14, 2007

    Report

    Report Number
    2916556-2007-00001
    Event Type
    Malfunction
    Date Received
    September 14, 2007
    Date of Event
    May 30, 2007
    Report Date
    August 16, 2007
    Manufacturer
    PHILIPS NUCLEAR MEDICINE, INC
    Product Code
    KPS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROBLEM IS STILL UNDER INVESTIGATION BY PHILIPS MEDICAL SYSTEMS-CLEVELAND AND PHILIPS NUCLEAR MEDICINE (MILPITAS, CA). A FOLLOW-UP REPORT WILL BE ISSUED DETAILING ADDITIONAL INVESTIGATION RESULTS AND CORRECTIVE/PREVENTATIVE ACTIONS, AS APPROPRIATE.

    Description of Event or Problem · 1

    AN MDR WAS FILED FOR THIS ISSUE - MFR. REPORT # 1525965-2007-00005. PROBLEM DETAILS: THE BRILLIANCE 64-SLICE CT IS MANAGED BY THE EXTENDED BRILLIANCE WORKSPACE (EBW) SOFTWARE. THIS WORKSPACE HAS AN OPTIONAL SOFTWARE APPLICATION FUNCTION NAMED CARDIAC VIEWER. USING THIS APPLICATION, IT IS POSSIBLE FOR IMAGES TO BE ZOOMED AND SAVED AS A NEW SET OF IMAGES. WHEN THE SAVED IMAGES ARE VIEWED USING CARDIAC VIEWER, OR ARE TRANSFERRED TO A PACS, MEASUREMENTS MADE ON THESE ZOOMED IMAGES ARE INCORRECT. THE MEASUREMENT ERROR IS PROPORTIONAL TO THE ZOOM FACTOR. AN IMAGE WHICH IS ZOOMED BY A FACTOR OF 2, WILL SHOW DISTANCE MEASUREMENTS THAT ARE INCORRECT AND ENLARGED BY A FACTOR OF 2. NO INJURIES WERE ASSOCIATED WITH THIS PROBLEM. THIS PROBLEM AFFECTS ALL BRILLIANCE CTS USING CT SCANNER SOFTWARE VER. S 2.0-2.2.5 AND EBW SOFTWARE VER.S 2.0-3.5.2. PHILIPS NUCLEAR MEDICINE (MILPITAS, CA) INCORPORATES THE AFFECTED APPLICATION (I.E., CT SCANNER SOFTWARE VERSION 2.0, EBW SOFTWARE VERSION 3.5) IN ITS PRECEDENCE SPECT/CT SYSTEM AND THE POTENTIAL FOR A SIMILAR MALFUNCTION EXISTS, PHILIPS NUCLEAR MEDICINE IS FILING THIS RELATED MFG. REPORT. NO SIMILAR EVENTS HAVE BENE REPORTED ON THE PRECEDENCE SPECT/CT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECEDENCE SPECT/CT NUCLEAR MEDICINE EQUIPMENT KPS PHILIPS NUCLEAR MEDICINE, INC 2169-3000A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA YR UNK.