BEUDAMED
    FDA Adverse Event Death Summary report: N

    STEELITE ISO GREEN LARYNGOSCOPE BLADE

    MDR report key: 2720254 · Received August 22, 2012

    Report

    Report Number
    1718887-2012-00002
    Event Type
    Death
    Date Received
    August 22, 2012
    Date of Event
    June 19, 2012
    Report Date
    July 23, 2012
    Manufacturer
    VITAL SIGNS COLORADO, INC.
    Product Code
    CCW
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    USER FACILITY MEDWATCH RECEIVED FROM THE CUSTOMER REPORTS, "ATTEMPTING TO INTUBATE DURING A CODE BLUE EVENT - A #3 DISPOSABLE BLADE MADE AVAILABLE TO MD FOR INTUBATION BUT FAILED AFTER MULTIPLE ATTEMPTS, AIRWAY MANAGEMENT TAKEN OVER BY ANOTHER MD ATTEMPTS WITH THE DISPOSABLE #4 BUT COULD NOT GET A VIEW BECAUSE THE BLADE KEPT COLLAPSING AND THE VIEW WAS HORRIBLE KEPT THIS MD THEN WENT BACK TO THE #3 ORIGINALLY USED WHEN THE INITIAL INTUBATION WAS ATTEMPTED. FINALLY, A NON-DISPOSABLE BLADE WAS USED WITH SUCCESSFUL INTUBATION. USE OF THIS DISPOSABLE PRODUCT ADDED TO DELAY WITH THE INTUBATION DUE TO THE SLENDER BLADE THE SUBGLOTTIS TISSUE FOLDED OVER THE BLADE OBSTRUCTING THE VIEW." EVENT DESCRIPTION STATES, "USED DURING ENDOTRACHEAL INTUBATION FOR CARDIAC ARREST." GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEELITE ISO GREEN LARYNGOSCOPE BLADE LARYNGOSCOPE, RIGID CCW VITAL SIGNS COLORADO, INC. 4613 5335L

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death