BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.5 TESLA GE SIGNA ARTIST WIDE BORE MRI SCANNER

    MDR report key: 17143510 · Received June 15, 2023

    Report

    Report Number
    MW5118430
    Event Type
    Injury
    Date Received
    June 15, 2023
    Date of Event
    June 12, 2023
    Report Date
    June 13, 2023
    Manufacturer
    GE HEALTHCARE MANUFACTURING LLC
    Product Code
    LNH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WE HAD A PATIENT THAT HAD AN MRI LUMBAR SPINE WITHOUT CONTRAST YESTERDAY (B)(6) 2023 AROUND 12:00 NOON AT OUR 1.5T GE MRI SCANNER. THE PATIENT CALLED TODAY(B)(6) 2023 AROUND 09:00 AM TO REPORT THAT SHE HAS A DIME SIZE BURN ON HER LEFT SIDE OF HER STOMACH OF HER BODY AT ABOUT LEFT HIP LEVEL (PT HAS A LARGE BODY HABITUS AND DUE TO THAT HER STOMACH HANGS QUITE LOW) AND SHE THINKS IT IS FROM HER MRI YESTERDAY. I TALKED TO THE PATIENT TODAY WHEN SHE CALLED THIS AM AT ABOUT 9AM AND SHE SAID THAT SHE HAD AN MRI YESTERDAY OF HER SPINE AND DURING THE MRI SCAN SHE DID FEEL SOME BURNING AROUND HER LEFT HIP AREA AND DID SQUEEZE HER CALL BELL TO ALERT THE TECHNOLOGIST. WHEN THE TECHNOLOGIST CHECKED IN ON HER SHE TOLD THE TECHNOLOGIST THAT SHE WAS HAVING PAIN/BURNING SENSATION IN LEFT HIP AREA. THE PATIENT SAID SHE REPOSITIONED HER HIPS AND THAT TOOK THE PAIN/BURNING SENSATION AWAY AND THE PATIENT DECIDED TO CONTINUE WITH THE MRI. I HAVE NOTIFIED OUR MRI MEDICAL DIRECTOR AND THE PATIENTS DOCTOR¿S OFFICE. OF NOTE, PATIENT WAS POSITIONED SUPINE FEET FIRST IN SCANNER WITH HER ARMS ABOVE HER HEAD (SHE WOULD NOT FIT IN THE SCANNER WITH HER ARMS DOWN BY HER SIDES) AND THERE WAS SUFFICIENT PADDING USED IN-BETWEEN THE PATIENT¿S BODY AND THE MRI GANTRY (BORE OF THE MAGNET). THERE WERE NO CORDS OR MONITORS ATTACHED TO THE PATIENT OR ANYTHING ELECTRONIC ATTACHED TO THE PATIENT. THE PATIENT WAS IN HER STREET CLOTHES FOR THE MRI AS SHE WOULD NOT FIT INTO OUR HOSPITAL SUPPLIED ATTIRE. THE TAGS OF THE PATIENTS CLOTHING WERE CHECKED PRE-MRI AND BOTH HER PANTS AND HER SHIRT SHE WORE DURING THE MRI WERE BOTH LABELED AS BEING COTTON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463474 1.5 TESLA GE SIGNA ARTIST WIDE BORE MRI SCANNER SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING LNH GE HEALTHCARE MANUFACTURING LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Other