BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINIA II (CODE/HAWKEYE)

    MDR report key: 667595 · Received January 20, 2006

    Report

    Report Number
    9613299-2006-00001
    Event Type
    Malfunction
    Date Received
    January 20, 2006
    Date of Event
    August 17, 2005
    Report Date
    January 20, 2006
    Manufacturer
    GE MEDICAL SYSTEMS F.I. HAIFA
    Product Code
    KPS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    AFTER ACQUIRING BRAIN AXIAL SLICE IMAGES USING THE INFINIA II "BRAIN COINCIDENCE WITH HAWKEYE" SCAN, SUBSEQUENT IMAGE PROOCESSING USING THE XELERIS PROCESSING AND REVIEWING WORKSTATION RESULTED IN IMAGE ATTENUATION CORRECTION ARTIFACTS. THE ATTENUATED CORRECTED IMAGES OF THE FRONTAL LOBE IDENTIFIED DECREASED UPTAKE ACTIVITY, BUT THE NON-ATTENUATED CORRECTED IMAGES DID NOT SHOW THIS FINDING. NO INJURIES WERE REPORTED. THE CONCERN IS FOR POSSIBLE MISDIAGNOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFINIA II (CODE/HAWKEYE) NUCLEAR MEDICINE KPS GE MEDICAL SYSTEMS F.I. HAIFA H3000WZ NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO