BEUDAMED
    FDA Adverse Event Death Summary report: N

    GE 1.5T SIGNA HDX MR SYSTEM

    MDR report key: 12739907 · Received November 2, 2021

    Report

    Report Number
    2183553-2021-00012
    Event Type
    Death
    Date Received
    November 2, 2021
    Date of Event
    October 14, 2021
    Report Date
    December 21, 2021
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    LNH
    PMA / PMN Number
    K052293
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: THE INVESTIGATION BY GE HEALTHCARE (GEHC) HAS BEEN COMPLETED. BASED ON THE INFORMATION PROVIDED, THE INCIDENT OCCURRED DUE TO LACK OF CONTROLLED ACCESS. THE MR TECHNICAL STAFF FAILED TO LIMIT AND MONITOR ACCESS TO THE MAGNET ROOM WHICH ALLOWED AN UNTRAINED MEMBER OF THE HOSPITAL STAFF TO BRING A FERROUS OXYGEN TANK AND CART INTO THE SCAN ROOM. THE MR SAFETY GUIDE OR THE OPERATOR MANUAL WITH INTEGRATED SAFETY SECTION, WHICH HAS BEEN DELIVERED TO THE CUSTOMER, CLEARLY DEFINES THE RISKS ASSOCIATED WITH OWNING AND OPERATING AN MR SCANNER. IT WAS CONFIRMED THAT THE FERROUS OBJECT WARNING SIGNS WERE PRESENT AT THE SITE. THE CUSTOMER SUCCESSFULLY ACTIVATED THE MAGNET RUN DOWN UNIT (MRU) WHICH RAMPED DOWN THE MAGNET AND THEY REMOVED THE OXYGEN TANK, CART, AND PATIENT FROM THE SCANNER. NO FURTHER ACTIONS ARE PLANNED BY GEHC.

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 60S. THERE ARE NO ADDITIONAL DEVICE IDENTIFICATION NUMBERS. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS BEING SCANNED, AND DUE TO HIS CRITICAL CONDITION, NEEDED TO STAY ON OXYGEN DURING HIS SCAN. THE PATIENT WAS CONNECTED TO AN OXYGEN TANK THAT WEIGHED MORE THAN 10KG AND PLACED APPROXIMATELY 2M AWAY. THE OXYGEN TANK AND CART WERE ATTRACTED TO, AND ENTERED THE MAGNET BORE, STRIKING THE PATIENT INSIDE. THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1637734 GE 1.5T SIGNA HDX MR SYSTEM NUCLEAR MAGNETIC RESONANCE IMAGING LNH GE MEDICAL SYSTEMS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Death