BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GE 1.5T SIGNA HDX MR SYSTEM

    MDR report key: 3647939 · Received February 6, 2014

    Report

    Report Number
    2183553-2014-00007
    Event Type
    Injury
    Date Received
    February 6, 2014
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    LNH
    PMA / PMN Number
    K052293
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT ID AND WEIGHT WERE REQUESTED BUT NOT PROVIDED TO GE HEALTHCARE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS BROUGHT TO THE EMERGENCY DEPARTMENT (ED) FOR A MR SCAN. THE PATIENT HAD MULTIPLE NON-MR COMPATIBLE ECG PATCHES PLACED ON THE SKIN BY THE ED. THE MR TECHNOLOGIST SCANNING THE PATIENT BELIEVED THEY HAD REMOVED ALL OF THE ECG PATCHES, HOWEVER, APPROXIMATELY 5 PATCHES REMAINED ON THE PATIENT. AT THE END OF THE EXAM, THE PATIENT COMPLAINED OF A BURNING SENSATION. UPON OBSERVATION BY THE TECHNOLOGIST, THE REMAINING ECG PATCHES WERE DISCOVERED AND THERE WAS REDNESS WHERE THE PATCHES WERE LOCATED. THE FOLLOWING DAY, THE PATIENT'S NURSE NOTED BURNS CONTAINING BLISTERS WHERE THE ECG PATCHES WERE LOCATED - APPROXIMATELY 0.5 CM WITH 1/8 INCHES OF SWELLING. THE PATIENT'S PHYSICIAN REPORTED THE AREAS WERE 2ND AND 3RD DEGREE BURNS. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR ONE DAY AFTER SUSTAINING THE BURNS AND WAS TREATED BY A GENERAL SURGEON. THE BURNS WERE OF VARYING DEGREES, THE WORST BEING 3RD DEGREE, COMPARABLE TO THE SIZE OF A QUARTER. WOUND CARE APPLIED A WOUND DRESSING TO THE BURNED AREAS. THE GENERAL SURGEON UTILIZED DEBRIDEMENT ON THE LARGEST BURN AREA. THERE WERE NO REPORTS OF INFECTION TO THE BURNED AREAS. THE PATIENT RECEIVED FOLLOW UP FOR THE FOUR WEEKS FOLLOWING THE EVENT. REPORTEDLY, THREE OF THE BURNED AREAS HAVE HEALED (CLOSED) AND ONE AREA IS NOW BEING TREATED WITH SALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78125 GE 1.5T SIGNA HDX MR SYSTEM MAGNETIC RESONANCE DIAGNOSTIC DEVICE LNH GE MEDICAL SYSTEMS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| O| R