BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINIA II (CODE / HAWKEYE)

    MDR report key: 680971 · Received February 27, 2006

    Report

    Report Number
    9613299-2006-00003
    Event Type
    Malfunction
    Date Received
    February 27, 2006
    Date of Event
    January 30, 2006
    Report Date
    February 27, 2006
    Manufacturer
    GE MEDICAL SYSTEMS FI HAIFA
    Product Code
    KPS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED REGARDING PIXAL SIZE DISTORTION APPEARING IN RECONSTRUCTED CODE IMAGES WHILE USING PIXAL SIZE OF 2.5MM. THE RELATIVE RELATIONSHIP OF THE IMAGE COMPONENTS IS CORRECT, HOWEVER, THE TRUE DIMENSION OF EACH BODY PART IS NOT CORRECT. A PATIENT WAS NOT INVOLVED AND 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 FI HAIFA H3000WZ NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA