BEUDAMED
    FDA Adverse Event Other Summary report: N

    3.0T HDX

    MDR report key: 921840 · Received March 22, 2007

    Report

    Report Number
    2183553-2007-00010
    Event Type
    Other
    Date Received
    March 22, 2007
    Date of Event
    January 16, 2007
    Report Date
    March 22, 2007
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    LNH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS A POSSIBILITY THAT THIS COULD LEAD TO MIS-INTERPRETATION BASED ON FLAIR IMAGES ALONE. HOWEVER, GOOD CLINICAL PRACTICE WOULD DICTATE THAT DIAGNOSTIC AND TREATMENT DECISIONS WOULD BE BASED ON PT OVERALL EXAM, CLINICAL SYMPTOMS AND LAB DATA ETC. AND NOT ON A SINGLE MRI SERIES. THE MR SYSTEM WAS OPERATING AS INTENDED AND THERE IS NO EVIDENCE THAT THE SYSTEM MALFUNCTIONED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROPELLER FLAIR SEQUENCE IS PRODUCING ITEMS THAT MIMIC REAL DISEASE. UPON REVIEW OF IMAGES IT COULD BE SEEN THAT SURFACE COIL INTENSITY CORRECTION (SCIC) IMAGE ENHANCEMENT OPTION MADE THE HIPPOCAMPUS BRIGHTER THAN THE IMAGES TAKEN WITH THE SCIC OPTION TURNED OFF. THE SCIC OPTION IS USED TO SMOOTH SURFACE COIL IMAGE INTENSITY VARIATIONS. NO INJURY OR MIS-DIAGNOSIS HAS BEEN REPORTED. ALTHOUGH NO SYSTEM FAILURES OCCURRED THIS IS AN UNANTICIPATED OUTCOME OF USING THE SCIC FEATURE WITH FLAIR IMAGES OF THE BRAIN WHICH IN SOME INSTANCES COULD POTENTIALLY LEAD TO MIS-INTERPRETATION OF IMAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.0T HDX MR LNH GE MEDICAL SYSTEMS, LLC MDF008 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO