BEUDAMED
    FDA Adverse Event Other Summary report: N

    EXCITE HD 1.5T

    MDR report key: 970104 · Received December 27, 2007

    Report

    Report Number
    2183553-2007-00036
    Event Type
    Other
    Date Received
    December 27, 2007
    Date of Event
    November 28, 2007
    Report Date
    November 28, 2007
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    LNH
    PMA / PMN Number
    K041476
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE FIELD ENGINEER REPORTED THAT WARNING SINGS WERE ON THE MAGNET DOORS, AND THE CUSTOMER WAS PROPERLY TRAINED IN MR SAFETY. SECTION A: ATTEMPTS TO OBTAIN PATIENT INFORMATION WERE UNSUCCESSFUL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN OXYGEN TANK AS BROUGHT INTO THE MAGNET ROOM AND THE TANK WAS ATTRACTED TO THE OUTSIDE FRONT OF THE MAGNET. NO INJURY WAS REPORTED. THE CONCERN IS FOR SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXCITE HD 1.5T LNH GE MEDICAL SYSTEMS, LLC 2131600 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR