BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAG RESUSCITATOR

    MDR report key: 11375 · Received February 8, 1994

    Report

    Report Number
    MW1000671
    Event Type
    Injury
    Date Received
    February 8, 1994
    Date of Event
    December 1, 1993
    Report Date
    January 21, 1994
    Manufacturer
    AMBU, INC.
    Product Code
    BTM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A 3-MO-OLD WITH SEVERE RESPIRATORY DISTRESS WAS BAGGED VIGOROUSLY AFTER INTUBATION. THE BLUE RUBBER OUTSIDE COVERING OF THE BAG POPPED LIKE A BALLOON. THE INFANT ALSO DEVELOPED BILATERAL SIGNIFICANT PNEUMOTHORAX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAG RESUSCITATOR BTM AMBU, INC. MODEL R NI

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO Hospitalization| L