BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISCOVERY MR750W 3.0T

    MDR report key: 2432857 · Received January 11, 2012

    Report

    Report Number
    2183553-2012-00005
    Event Type
    Malfunction
    Date Received
    January 11, 2012
    Date of Event
    December 7, 2011
    Report Date
    December 14, 2011
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    LNH
    PMA / PMN Number
    K103327
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MALFUNCTION WAS NOT REPORTED FOR A SPECIFIC SYSTEM, BUT IT WAS IDENTIFIED DURING A GE HEALTHCARE (GEHC) INVESTIGATION SO DEVICE SERIAL NUMBER IS NOT APPLICABLE (N/A). INITIAL REPORTER INFO IS NOT APPLICABLE AS THIS WAS REPORTED DURING A GE HEALTHCARE (GEHC) INVESTIGATION. THIS MALFUNCTION WAS NOT REPORTED FOR A SPECIFIC SYSTEM BUT IT WAS IDENTIFIED DURING A GE HEALTHCARE (GEHC) INVESTIGATION SO DEVICE MFG DATE IS NOT APPLICABLE (N/A).

    Description of Event or Problem · 1

    DURING A GE HEALTHCARE INVESTIGATION, THE FOLLOWING ISSUE WAS DISCOVERED ON THE DISCOVERY MR750W 3.0T. WHEN USING THE BRAVO PULSE SEQUENCE DATABASE (PSD) DURING A BRAIN SCAN AND THE USER RUNS A SAGITTAL SERIES, THEN COPY/ PASTE THIS SERIES AND GRAPHICALLY PRESCRIBE IMAGES IN THE TRANSVERSE (AXIAL) PLANE WITH A FREQUENCY OF RIGHT/ LEFT, THE AXIAL IMAGES WILL FLIP IN THE HORIZONTAL (RIGHT/LEFT DIRECTION). THE ORIENTATION MARKERS DO NOT MOVE WITH THE FLIPPED IMAGES RESULTING IN IMAGES FLIPPED WITH INCORRECT ANNOTATIONS. AS AXIAL IMAGES ARE SYMMETRICAL WITHIN THE BRAIN, THIS FLIP WOULD NOT BE OBVIOUS TO THE CAREGIVER AND COULD RESULT IN A MISDIAGNOSIS OR MISTREATMENT. THE ISSUE HAS BEEN FOUND IN HOUSE AND NO INJURIES HAVE BEEN REPORTED FROM THE FIELD. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A F/U REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISCOVERY MR750W 3.0T MAGNETIC RESONANCE DIAGNOSTIC DEVICE LNH GE MEDICAL SYSTEMS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1