BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.5T SIGNA HDX ECHOSPEED

    MDR report key: 2051549 · Received April 7, 2011

    Report

    Report Number
    2183553-2011-00014
    Event Type
    Injury
    Date Received
    April 7, 2011
    Date of Event
    February 14, 2011
    Report Date
    April 7, 2011
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    LNH
    PMA / PMN Number
    K052293
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GEHC LOCAL FIELD TEAM WAS DISPATCHED TO THE CUSTOMER SITE TO OBTAIN SCAN SPECIFIC INFORMATION 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: (SYSTEMS LEVEL TESTING TO CHECK FOR SYSTEM FAILURES). PT MONITORING: (PT ALARM & 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT SUSTAINED A SECOND DEGREE BURN ON THE MIDDLE OF HER BACK TO THE RIGHT OF THE MIDLINE DURING A MAGNETIC RESONANCE (MR) SCAN. THE PT WAS BEING SCANNED WITH THE 8 CHANNEL CTL COIL FOR A LUMBAR SPINE SCAN. THE PT WAS POSITIONED HEAD FIRST AND SUPINE, AND THE PT'S ARMS WERE POSITIONED OVER HER HEAD. THE PT REPORTEDLY FELT REDNESS AND DISCOMFORT, BUT SHE DID NOT INDICATE THIS DIRECTLY AFTER HER MR SCAN. SHE CONTACTED THE SITE 10 DAYS AFTER THE SCAN. THE HOSPITAL STATED THAT THE PT WAS PROPERLY ISOLATED FROM THE BORE. THE COMBINED SIZE OF THE BLISTERS WAS 2 X 3 CM. THE PULSE SEQUENCES USED WERE NOT PROVIDED. THE PT DID NOT SEEK ANY MEDICAL TREATMENT FOR THIS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1.5T SIGNA HDX ECHOSPEED MAGNETIC RESONANCE DIAGNOSTIC SYSTEM LNH GE MEDICAL SYSTEMS, LLC 5308573

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other