BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGNA CVI

    MDR report key: 2271754 · Received September 28, 2011

    Report

    Report Number
    2183553-2011-00036
    Event Type
    Injury
    Date Received
    September 28, 2011
    Date of Event
    August 29, 2011
    Report Date
    September 28, 2011
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    LNH
    PMA / PMN Number
    K041476
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE HEALTHCARE FIELD ENGINEER WAS ON SITE AND EVALUATED THE DEVICE AND OPERATIONAL ENVIRONMENT. THE DEVICE PERFORMED ACCORDING TO SPECIFICATIONS THE SYSTEM IS DESIGNED TO COMPLY WITH IEC 60601-2-33, INCLUDING THE REQUIREMENTS INTENDED TO MINIMIZE THE LIKELIHOOD OF PT WARMING. THE DEVICE LABELING WAS REVIEWED AND THE WORKING SAFELY SECTION OF THE MR SAFETY GUIDE DEFINES PROPER PT POSITIONING AND PADDING TO PREVENT WARMING DURING MRI SCANS BUT THESE WERE NOT FOLLOWED BY THE USER. THE INJURY WAS ATTRIBUTED TO USER ERROR SINCE PADDING WAS NOT USED TO PREVENT SKIN TO SKIN CONTACT. NO FURTHER ACTIONS ARE PLANNED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT RECEIVED A BURN ON (B)(6) 2011 TO THE LEFT THIGH WHILE BEING SCANNED ON A SIGNA CVI. THE PT ENTERED THE MAGNET FEET FIRST FOR A KNEE EXAM AND WAS PADDED WITH 2 1/2 INCH PADS BETWEEN THE PT AND THE BORE. PADDING WAS NOT USED FOR SKIN TO SKIN CONTACT AND THE PTS THIGHS WERE TOUCHING. THE PT SUSTAINED A HOT BURNING SENSATION TO THE OUTER THIGH WHILE BEING SCANNED WHICH DEVELOPED INTO A BLISTER 3" X 3". THE BLISTER WAS RUPTURED AND THE PT WAS GIVEN PREVENTATIVE MEDICINE TO TAKE. THERE WAS NO SIGN OF INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGNA CVI MAGNETIC RESONANCE DIAGNOSTIC DEVICE LNH GE MEDICAL SYSTEMS, LLC 5107849-3

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other