BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GE SIGNA ARCHITECT

    MDR report key: 14137137 · Received April 15, 2022

    Report

    Report Number
    MW5109084
    Event Type
    Injury
    Date Received
    April 15, 2022
    Date of Event
    March 31, 2022
    Report Date
    April 14, 2022
    Manufacturer
    GE HEALTHCARE MANUFACTURING LLC
    Product Code
    LNH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    501
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    WHILE UNDERGOING A SHOULDER MRI EXAM, A PATIENT RECEIVED A SMALL (5 CMX2 CM) THERMAL INJURY (BURN) TO LATERAL ASPECT OF CHEST WALL (RIGHT SIDE JUST INFERIOR TO PATIENT AXILLA). THE PATIENT WAS POSITIONED WITH PADDING PLACED BETWEEN BODY AND SCANNER BORE WALL. IT IS SUSPECTED THAT THIS AREA PROTRUDED UNDER THE PADDING AND TOUCHED THE BORE OF THE SCANNER DURING THE TEST. PATIENT WAS EVALUATED BY A PHYSICIAN AND DETERMINED TO HAVE A SLIGHT 1ST DEGREE BURN (LIGHT RED AREA). THE PATIENT WAS GIVEN INSTRUCTION FOR CARE AND TO EVALUATE THE AREA. THE PATIENT WAS CONTACTED 24 HOURS AFTER THE EVENT AND INFORMED THE FACILITY THAT THE READ AREA HAS RESOLVED AND HAD NO OTHER SYMPTOMS. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2717132 GE SIGNA ARCHITECT SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING LNH GE HEALTHCARE MANUFACTURING LLC 3T MRI SCANNER

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Other