BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE EXHALATION VALVE

    MDR report key: 8023814 · Received October 31, 2018

    Report

    Report Number
    8023814
    Event Type
    Malfunction
    Date Received
    October 31, 2018
    Date of Event
    October 11, 2018
    Report Date
    October 23, 2018
    Manufacturer
    DRAEGER, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    UPON ARRIVAL THE VENTILATOR WAS ATTACHED TO THE PATIENT AND NOT DELIVERING ANY BREATHS. THE VENTILATOR SOUNDED LIKE THE EXPIRATORY VALVE WAS STICKING. THE PATIENT WAS MANUALLY VENTILATED WITH AMBU BAG. ATTEMPTED TO REPLACE EXPIRATORY LIMB OF CIRCUIT, EXPIRATORY VALVE, AND FLOW SENSOR. THE PROBLEM REOCCURRED. THE DEVICE WAS REMOVED FROM SERVICE AND PATIENT PLACED ON A NEW DEVICE. UPON INSPECTION, EXPIRATORY VALVE DIAPHRAGM APPEARED TO HAVE A DEFECT. ADDITIONAL PRODUCT PULLED FROM INVENTORY FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    867005 DISPOSABLE EXHALATION VALVE CBK DRAEGER, INC. MP01060 34280537

    Patients

    Seq Age Sex Outcome Treatment
    1 26280 DA