BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGNA OPENSPEED

    MDR report key: 2432842 · Received January 11, 2012

    Report

    Report Number
    2183553-2012-00004
    Event Type
    Malfunction
    Date Received
    January 11, 2012
    Date of Event
    December 13, 2011
    Report Date
    December 13, 2011
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    LNH
    PMA / PMN Number
    K012875
    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

    UPON INVESTIGATION OF A REPORT OF FLIPPED IMAGES ON THE SIGNA 1.5 ECHO (MDR 2183553-2011-00039) WHEN PULLED FROM PACS TO A SYSTEM WITH SOFTWARE VERSION 9.1, THE SOFTWARE TEAM HAS DETERMINED THAT THE SIGNA OPENSPEED PRODUCT MAY ALSO HAVE THE REPORTED ISSUE. DUE TO THE ANATOMY OF THE SPINE AND/OR HEAD AN AXIAL IMAGE FLIPPED HORIZONTALLY MAY NOT BE EASILY DETECTED RESULTING IN AN INCORRECT TREATMENT AND/OR DIAGNOSIS. THERE HAS BEEN NO REPORTS FROM CUSTOMERS THAT THIS MALFUNCTION HAS OCCURRED IN RELATION TO THE SIGNA OPENSPEED. 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 SIGNA OPENSPEED MAGNETIC RESONANCE DIAGNOSTIC DEVICE LNH GE MEDICAL SYSTEMS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1