BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGNA 0.2T PROFILE WITH EXCITE

    MDR report key: 2519791 · Received April 4, 2012

    Report

    Report Number
    9613445-2012-00004
    Event Type
    Malfunction
    Date Received
    April 4, 2012
    Date of Event
    March 6, 2012
    Report Date
    March 6, 2012
    Manufacturer
    GE HANGWEI MEDICAL SYSTEMS CO., LTD.
    Product Code
    LNH
    PMA / PMN Number
    K043112
    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. 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.

    Description of Event or Problem · 1

    DURING A GE HEALTHCARE INVESTIGATION OF A REPORT THAT T1 WEIGHTED CUBE IMAGES WERE FLIPPED HORIZONTALLY WHEN THESE IMAGES WERE REFORMATTED (MDR 2183553-2012-00014), IT WAS FOUND THIS COULD ALSO OCCUR IN THE SIGNA 0.2T PROFILE WITH EXCITE MR SCANNER. 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 0.2T PROFILE WITH EXCITE MAGNETIC RESONANCE DIAGNOSTIC DEVICE LNH GE HANGWEI MEDICAL SYSTEMS CO., LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1