BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MELLENNIUM VG

    MDR report key: 610989 · Received July 12, 2004

    Report

    Report Number
    9613299-2004-00008
    Event Type
    Malfunction
    Date Received
    July 12, 2004
    Date of Event
    May 5, 2004
    Report Date
    July 12, 2004
    Manufacturer
    GE MEDICAL SYSTEMS F.I. HAIFA
    Product Code
    IYX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER COMPLAINT WAS RECEIVED CONCERNING INTERMITTENT FALSE RESULTS OF THE EJECTION FRACTION (EF) CALCULATION IN THE MUGA APPLICATION. INCONSISTENT EF CALCULATION AND TIME ACTIVITY CURVED SHAPES WITH RESPECT TO ACTTUAL HEART FUNCTION WERE REPORTED. THE CONCERN IS FOR MISDIAGNOSIS IF THE CALCULATED EF IS LOWER THAN IT SHOULD BE. NO INJURY OF MISDIAGNOSIS WAS REPORTED NOR ANY OTHER ADVERSE EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MELLENNIUM VG NUCLEAR MEDIDCINE GAMMA CAMERA IYX GE MEDICAL SYSTEMS F.I. HAIFA ASM00085 *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA