BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GE OPTIMA 450W

    MDR report key: 11744562 · Received April 28, 2021

    Report

    Report Number
    MW5101069
    Event Type
    Injury
    Date Received
    April 28, 2021
    Date of Event
    April 24, 2021
    Report Date
    April 27, 2021
    Manufacturer
    GE HEALTHCARE MANUFACTURING LLC
    Product Code
    LNH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT RECEIVED A BURN FROM CARDIAC MONITORING WIRES TUCKED UNDER THE PATIENT LEG. PATIENT RECEIVED A 1MM IN DIAMETER BURN AND WAS TREATED FROM THE EMERGENCY DEPARTMENT. PATIENT WAS ADMITTED AND HAD SURGICAL RELIEF FROM A SPINAL STENOSIS CONDITION AND WAS ALSO TREATED FOR BURN DURING ADMISSION. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638593 GE OPTIMA 450W SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING LNH GE HEALTHCARE MANUFACTURING LLC 5790115

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other