BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITAL SIGNS, INC

    MDR report key: 66093 · Received January 2, 1997

    Report

    Report Number
    66093
    Event Type
    Injury
    Date Received
    January 2, 1997
    Date of Event
    October 31, 1996
    Report Date
    November 1, 1996
    Manufacturer
    VITAL SIGNS, INC.
    Product Code
    EQN
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING INTUBATION THE LARYNGOSCOPE BLADE BROKE OFF IN PT'S MOUTH INTERFERRING WITH ABILITY TO INTUBATE AND VENTILATE THE PT. THIS CAUSED THE PT'S TOOTH TO BREAK. DURING INABILITY TO VENTILATE, PT BECAME HYPOXIC AND SUBSEQUENT CARDIAC ARREST. MICU STAFF PRESENT DURING EVENT. PT CONTINUE TO BE ICU POST ARREST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITAL SIGNS, INC FIBER OPTIC LARYNGOSCOPE BLADE EQN VITAL SIGNS, INC. 4503 MAC3 190G

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Life Threatening| R