BEUDAMED
    FDA Adverse Event Other Summary report: N

    GE BRAIN WAVE OPTIONS FOR MRI SYSTEMS

    MDR report key: 858526 · Received May 31, 2007

    Report

    Report Number
    2183553-2007-00017
    Event Type
    Other
    Date Received
    May 31, 2007
    Date of Event
    February 28, 2006
    Report Date
    May 30, 2007
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    LNH
    PMA / PMN Number
    K033867
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS A POSSIBILITY THAT THIS ISSUE COULD LEAD TO MISDIAGNOSIS. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FUNCTIONAL MRI IMAGES WERE MISMAPPED ONTO THE HIGH RESOLUTION ANATOMICAL IMAGES AFTER A BRAIN SCAN USING A SIGNA HD MR SCANNER WITH BRAINWAVE OPTION. THIS PROBLEM WAS ATTRIBUTED TO A SOFTWARE ERROR THAT OCCURS DURING PARTICULAR CIRCUMSTANCES. THE PROBLEM OCCURS WHEN ANATOMICAL IMAGES ARE OBTAINED IN THE I-S DIRECTION, BUT DOES NOT HAPPEN WHEN IMAGES ARE ACQUIRED IN THE S-I DIRECTION. IF NOT DETECTED BY THE HEALTHCARE PROFESSIONAL THEN THIS PROBLEM COULD POTENTIALLY AFFECT DIAGNOSIS OR TREATMENT DECISIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE BRAIN WAVE OPTIONS FOR MRI SYSTEMS LNH GE MEDICAL SYSTEMS, LLC M1060YW NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR