BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GE HEALTHCARE

    MDR report key: 7922271 · Received September 28, 2018

    Report

    Report Number
    7922271
    Event Type
    Injury
    Date Received
    September 28, 2018
    Date of Event
    September 19, 2018
    Report Date
    September 24, 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 MEDIAL LEFT ELBOW. PT WAS PLACED IN A HOSP GOWN AND SCREENED PRIOR TO SCAN. PT WAS THICK IN BODY STRUCTURE, THEREFORE UNABLE TO UTILIZE THE POSITIONING SPONGES BUT WAS MUMMIFIED WITH SHEET TO KEEP SKIN FROM TOUCHING THE SIDE OF THE MAGNET BORE. THERE WERE NO MONITORING WIRES, LEADS, MED PATCHES NEAR THE BURN SITE. THE PT WAS BROUGHT OUT OF THE SCANNER POST EACH SCAN (C, T, L-SPINE). EACH SCAN WAS APPROX 20 MINS IN LENGTH. AT EACH BREAK PT WAS ASKED IF THERE WERE ANY PROBLEMS. RESPONSE WAS NO EACH TIME. ONCE ALL SCANS WERE COMPLETED, PT DID STATE THAT HER LEFT ELBOW AREA WAS WARM. THE LEFT ELBOW HAD ERYTHEMA WITH A SMALL BLISTER FORMING. THE NEXT MORNING THE BLISTER AND GROWN TO APPROX TO 2.6CM. THE PT WAS TREATED WITH 1% SILVADENE CREAM AND WOUND CONSULT WAS ORDERED. THE PT WILL BE TREATED BY THE HOSPITALIST DURING HER STAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761887 GE HEALTHCARE MRI SIGNS EXCITE SCANNER LNH GE HEALTHCARE 237500-2

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other