BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.5T SIGNA HDX

    MDR report key: 2465270 · Received February 21, 2012

    Report

    Report Number
    2183553-2012-00012
    Event Type
    Injury
    Date Received
    February 21, 2012
    Date of Event
    January 10, 2012
    Report Date
    January 27, 2012
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    LNH
    PMA / PMN Number
    K052293
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A THIRD PARTY FIELD ENGINEER TESTED THE EQUIPMENT, REVIEWED SCAN SPECIFIC INFORMATION AND INVESTIGATED THE ENVIRONMENTAL CONDITIONS. HE ALSO COMPLETED THE GE HEALTHCARE WARMING QUESTIONNAIRE. THE INVESTIGATION FOCUSED ON FOUR MAIN AREAS: ENVIRONMENTAL: (INCLUDING COOLING EQUIPMENT, PATIENT 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). PATIENT MONITORING: (PATIENT 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 DEVICE LABELING WAS REVIEWED AND THE WORKING SAFELY SECTION OF THE MR SAFETY GUIDE 2381696-100, REV 12, DEFINES PROPER PATIENT POSITIONING AND PADDING TO PREVENT WARMING DURING MRI SCANS. THE ROOT CAUSE OF THE INJURY COULD NOT BE DETERMINED. NO FURTHER ACTIONS ARE PLANNED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT SUSTAINED A SECOND DEGREE BURN IN HIS LEFT FOREARM AFTER BEING SCANNED WITH A 1.5 SIG NA HEX FOR A PELVIS/THIGH EXAMINATION. DURING THE EXAM THE PATIENT WAS POSITIONED SUPINE/FEET FIRST AND HE WAS HOLDING HIS HANDS AGAINST HIS CHEST. AFTER THE EXAM, THE PATIENT STATED THAT HIS FOREARM FELT LIKE IT WAS BURNING. HE DEVELOPED AN AREA OF REDNESS AND SMALL TINY BLISTERS OF APPROXIMATELY CM. HE ALSO HAD A BLISTER EQUIVALENT TO THE SIZE OF A QUARTER (APPROXIMATELY 2.5 CM). THE PATIENT WAS PADDED AWAY FROM THE BORE, BUT THE HOSPITAL CANNOT CONFIRM IF THERE WAS SKIN TO SKIN CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1.5T SIGNA HDX MAGNETIC RESONANCE DIAGNOSTIC DEVICE LNH GE MEDICAL SYSTEMS, LLC 2294302

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other