BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.5 HD SYSTEM

    MDR report key: 1083347 · Received July 28, 2008

    Report

    Report Number
    2183553-2008-00032
    Event Type
    Malfunction
    Date Received
    July 28, 2008
    Date of Event
    July 9, 2007
    Report Date
    July 9, 2007
    Manufacturer
    GE MEDICAL SYSTEMS, LLC.
    Product Code
    LNH
    PMA / PMN Number
    K041476
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FE REPLACED THE RF BODY COIL. NO SIMILAR OCCURRENCE WAS OBSERVED SINCE THE REPLACEMENT. THE BORE COVERS ARE FLAME RESISTANT AND IS UL94-V0 RATED. THE SYSTEM'S OPERATOR MANUAL INSTRUCTS THE USER TO PERFORM A SYSTEM SHUTDOWN WHEN A SERIOUS EQUIPMENT FAULT IS EXPERIENCED. ADDITIONAL INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SITE WAS EXPERIENCING IMAGE QUALITY ISSUES. THE FIELD ENGINEER (FE) PERFORMED AN INVESTIGATION AT THE SITE AND FOUND BURNED CAPACITORS ON THE RF BODY COIL. NO INJURY WAS REPORTED. THE CONCERN IS FOR A POSSIBLE BURN IF THE PATIENT WAS TO COME IN CONTACT WITH THE BORE WALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1.5 HD SYSTEM LNH GE MEDICAL SYSTEMS, LLC. 2397571 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA