BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGNA EXCITE 1.5T

    MDR report key: 2440775 · Received January 31, 2012

    Report

    Report Number
    2183553-2012-00008
    Event Type
    Injury
    Date Received
    January 31, 2012
    Date of Event
    December 1, 2011
    Report Date
    January 6, 2012
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    LNH
    PMA / PMN Number
    K041476
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE NUMBER AND OCCUPATION WERE NOT PROVIDED. A GE HEALTHCARE LOCAL FIELD TEAM WAS DISPATCHED TO THE CUSTOMER SITE TO OBTAIN SCAN SPECIFIC INFO AND INVESTIGATE THE ENVIRONMENTAL CONDITIONS. THE INVESTIGATION FOCUSED ON FOUR MAIN AREAS: ENVIRONMENTAL: (INCLUDING COOLING EQUIPMENT, PT AIR COOLING PLUS THE MR SCANNER ERROR LOG). SURFACE COILS/ACCESSORIES: (SURFACE COIL/ECG CHECKS). SYSTEM/IMAGE QUALITY: (SYSTEM LEVEL TESTING TO CHECK FOR SYSTEM FAILURES). PT MONITORING: (PT ALARM AND RF SAFETY MONITOR CHECKS). VISUAL INSPECTION AND THE TEST RESULTS FOR THE MRI SYSTEM SHOW NO ISSUES THAT CAUSED OR CONTRIBUTED TO THE BURN. THE SYSTEM WAS DETERMINED TO BE FUNCTIONING WITHIN SPECIFICATIONS. THE ROOT CAUSE OF THE INJURY COULD NOT BE DETERMINED. NO FURTHER ACTIONS ARE PLANED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT SUSTAINED A BURN AFTER HE WAS SCANNED WITH A SIGNA EXCITE 1.5T FOR BILATERAL KNEES (FIRST LEFT KNEE THEN RIGHT KNEE AND BOTH STUDIES FINISHED OK, EACH STUDY LASTED APPROX 23 MINUTES). THE PT LEFT THE SITE WITHOUT ANY PROBLEMS, BUT AFTER 10 DAYS, HE RETURNED AND INFORMED THE HOSPITAL THAT ON THE 8TH DAY, BURNS APPEARED ON HIS RIGHT KNEE, IN THE ZONE WHERE THE COIL WAS LOCATED. THE SIZE OF THE BLISTERS COMBINED APPEAR TO BE GREATER THAN 2.5CM. THE PT WAS SEEN BY A DERMATOLOGY SPECIALIST. THE PT WAS PADDED DURING THE EXAM, BOTH AWAY FROM THE SIDES OF THE BORE AND OTHER SKIN TO SKIN CONTACT AREAS. EACH KNEE THAT WAS SCANNED WAS ALSO PADDED BETWEEN THE KNEE AND THE COIL. THE PT WAS SCANNED WITH THE MEDICAL ADVANCED KNEE COIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGNA EXCITE 1.5T MAGNETIC RESONANCE DIAGNOSTIC DEVICE LNH GE MEDICAL SYSTEMS, LLC 2383613-2

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR