BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMBU (SP8R) DISPOSABLE RESUSCITATOR

    MDR report key: 88971 · Received February 15, 1995

    Report

    Report Number
    88971
    Event Type
    Injury
    Date Received
    February 15, 1995
    Date of Event
    October 1, 1994
    Report Date
    October 11, 1994
    Manufacturer
    AMBU, INC.
    Product Code
    BTM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    THERAPIST WAS BAGGING VENTILATOR PT. INNER DIAMETER OF AMBU BAG SWIVEL BROKE OFF ONTO PT'S E.T. TUBE. UNABLE TO BAG PT UNTIL NEW BAG SET UP. THERAPIST HAD TO REMOVE SWIVEL ADAPTER ON NEW SET UP BEFORE PROCEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMBU (SP8R) DISPOSABLE RESUSCITATOR MANUAL RESUSCITATOR BTM AMBU, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention