BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGNA HIGHSPEED 1.5T LX

    MDR report key: 2954200 · Received January 15, 2007

    Report

    Report Number
    2183553-2007-00002
    Event Type
    Injury
    Date Received
    January 15, 2007
    Date of Event
    December 18, 2006
    Report Date
    January 15, 2007
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    LNH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON-SITE INVESTIGATION OF THE SYSTEM INVOLVED IN THIS INCIDENT. THE SYSTEM WAS FOUND TO BE OPERATING WITHIN SPECIFICATION. WARNINGS AND INSTRUCTIONS RELATED TO THIS HAZARD ARE INCLUDED IN THE SYSTEM'S LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT SUSTAINED A BURN ON HER ELBOW DURING A MR SCAN. DURING THE SCAN, THE PT INFORMED THE OPERATOR THAT HER ELBOW WAS GETTING VERY WARM. SHE LATER SOUGHT MEDICAL ATTENTION FROM A DIFFERENT HEALTHCARE PROVIDER, AND INFORMED THE USER FACILITY THAT PERFORMED THE SCAN OF HER INJURY VIA PHONE. THE INJURY WAS DESCRIBED AS A 2ND DEGREE BURN WITH BLISTERING. THE PT SUSTAINED BURNS RESULTING FROM CONTACT POINT HEATING DUE TO INADEQUATE PT PADDING, WHICH ALLOWED THE PT'S ARM TO DIRECTLY CONTACT THE BORE WALL. NO OTHER DETAILS OF THE SIZE AND SEVERITY OF THE INJURY WERE PROVIDED. ATTEMPTS BY THE USER FACILITY TO F/U WITH THE PT WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGNA HIGHSPEED 1.5T LX MR LNH GE MEDICAL SYSTEMS, LLC 2226300 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention