BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GE HEALTHCARE

    MDR report key: 7664147 · Received July 3, 2018

    Report

    Report Number
    7664147
    Event Type
    Injury
    Date Received
    July 3, 2018
    Date of Event
    June 14, 2018
    Report Date
    June 27, 2018
    Manufacturer
    GE HEALTHCARE
    Product Code
    LNH
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    PT RECEIVED A BURN ON THE RIGHT HUMERAL POSTERIOR AREA. PT WAS PLACED IN A HOSPITAL GOWN, SCREENED, THEN SEDATED BY ANESTHESIOLOGIST. PT WAS THICK IN BODY STRUCTURE THEREFORE UNABLE TO UTILIZE THE POSITIONING SPONGES BUT WAS MUMMIFIED WITH BLANKET AND SHEET TO KEEP FROM SKIN TOUCHING THE SIDE OF THE BORE. THERE WERE NO MONITORING WIRES, LEADS, MED PATCHES NEAR THE AFFECTED SITE. PT WAS IN THE SCANNER ON AND OFF FOR APPROX ONE HOUR AND THIRTY MINS. THE SCAN WAS STOPPED SEVERAL TIMES DURING THIS TIME PERIOD TO ADMINISTER CONTRAST AND CHECK THE PT. THE PT WAS ALWAYS COVERED WITH THE BLANKET AND SHEET. ONCE THE SCAN WAS COMPLETED, THE PT WAS TAKEN TO PACU FOR RECOVERY (STANDARD PROCEDURE). THE PT COMPLAINED OF RIGHT UPPER EXTREMITY PAIN. THE AREA WAS TENDER TO THE TOUCH AND FELT WARM ACCORDING TO THE ATTENDING NURSE'S RECORD. THERE WAS APPROX A 5 CM. AREA OF ERYTHEMA OF THE RIGHT UPPER EXTREMITY JUST BELOW THE SHOULDER LATTERLY. THERE WERE SEVERAL SMALL SKIN BLISTERS AT THE SITE. THE PT WAS TREATED BY THE HOSPITALIST. THE AREA WAS FOLLOWED BY THE HOSPITALIST OVER THE NEXT FEW DAYS. PT WAS DISCHARGED WITH NO F/U NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499656 GE HEALTHCARE MRI SIGNA EXCITE SCANNER LNH GE HEALTHCARE 237500-2

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other