BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KING VISION

    MDR report key: 5546805 · Received April 1, 2016

    Report

    Report Number
    MW5061451
    Event Type
    Injury
    Date Received
    April 1, 2016
    Date of Event
    March 17, 2016
    Report Date
    March 18, 2016
    Manufacturer
    KING SYSTEMS (AMBU)
    Product Code
    OGH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    0

    Narratives

    Description of Event or Problem · 1

    THE KING VISION VIDEO LARYNGOSCOPE WAS USED DURING A FIRST ATTEMPT OF ENDOTRACHEAL INTUBATION. DURING THE ATTEMPT, THE USER IDENTIFIED A FOREIGN OBJECT IN THE AIRWAY. THE KING VISION WAS SET DOWN WHILE THE FOREIGN OBJECT WAS BEING REMOVED. THE KING VISION WAS AGAIN PICKED UP TO BE USED FOR A SECOND ATTEMPT OF ENDOTRACHEAL INTUBATION WHEN IT WAS IDENTIFIED THAT THE UNIT WAS STILL POWERED ON, BUT THE VIDEO SCREEN WAS NO LONGER FUNCTIONING. THE KING VISION WAS SET ASIDE AND FIBEROPTIC LARYNGOSCOPY WAS USED TO PERFORM THE ENDOTRACHEAL INTUBATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197907 KING VISION KING VISION OGH KING SYSTEMS (AMBU)

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention