BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMBU KING MASK

    MDR report key: 5999289 · Received October 5, 2016

    Report

    Report Number
    5999289
    Event Type
    Malfunction
    Date Received
    October 5, 2016
    Date of Event
    August 25, 2016
    Report Date
    September 29, 2016
    Manufacturer
    AMBU, INC.
    Product Code
    BSJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INFANT DESAT TO THE 30'S. BAG/MASK TURNED ON. BAG INFLATED EASILY. INFANT SUCTIONED BUT REMAINED APNEIC WITH HR DOWN TO 50S. STARTED ON POSITIVE PRESSURE VENTILATION (PPV) WITH INEFFECTIVE PEAK INSPIRATORY PRESSURE (PIP) SO BAG WAS SWITCHED OUT. WITHIN SECONDS OF USING NEW BAG, INFANT WAS PROPERLY VENTILATED AND HEART RATE (HR)/O2 SATS RETURNED TO NORMAL. INFANT WAS TRANSFERRED TO NICU IN OPEN CRIB ON RA. THERE WAS A TEAR IN THE MASK SO A SEAL COULD NOT BE ACHIEVED. THE BAG WAS IN WORKING ORDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652105 AMBU KING MASK MASK, GAS, ANESTHETIC BSJ AMBU, INC. SIZE 2

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR Other