BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGNA 3.0T MR750

    MDR report key: 2495955 · Received March 8, 2012

    Report

    Report Number
    2183553-2012-00014
    Event Type
    Malfunction
    Date Received
    March 8, 2012
    Date of Event
    December 21, 2011
    Report Date
    February 9, 2012
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    LNH
    PMA / PMN Number
    K081028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER OCCUPATION WAS NOT PROVIDED.

    Description of Event or Problem · 1

    T1 WEIGHTED CUBE IMAGES WERE ACQUIRED OF THE BRAIN FROM A SIGNA 3.0T MR750 SCANNER. WHEN THESE IMAGES WERE REFORMATTED, THE AXIAL BRAIN IMAGES WERE FLIPPED HORIZONTALLY. THE ORIENTATION MARKERS DO NOT FLIP WITH THE IMAGE. T1 WEIGHTED IMAGES ARE COMMONLY USED FOR TUMOR DETECTION OR DELINEATION IN CONJUNCTION WITH A CONTRAST AGENT. CERTAIN PATHOLOGY WOULD ONLY BE APPARENT ON THIS SEQUENCE. THIS EVENT DID NOT RESULT IN A MISDIAGNOSIS OR PT INJURY. AS THE BRAIN ANATOMY IS SYMMETRICAL A FLIP MAY NOT BE OBVIOUS TO THE CAREGIVER AND HAS A POTENTIAL OF A MISDIAGNOSIS OR MISTREATMENT. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGNA 3.0T MR750 MAGNETIC RESONANCE DIAGNOSTIC DEVICE LNH GE MEDICAL SYSTEMS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1