BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITAL SIGNS, INC.

    MDR report key: 48584 · Received November 1, 1996

    Report

    Report Number
    48584
    Event Type
    Injury
    Date Received
    November 1, 1996
    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 INTERFERING WITH ABILITY TO INTUBATE AND VENTILATE THE PT. PT'S TOOTH BROKE. DURING INABILITY TO VENTILATE, PT BECAME HYPOXIC AND SUBSEQUENT CARDIAC ARREST. MICU STAFF PRESENT DURING EVENT. PT CONTINUES TO BE IN 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