BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIRFLOW SMALL ADULT RESUSCITATION AF 5000 SERIES

    MDR report key: 2973844 · Received February 14, 2013

    Report

    Report Number
    MW5029024
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    February 12, 2013
    Report Date
    February 14, 2013
    Manufacturer
    VENTLAB CORPORATION
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHEN USING THE AMBU BAG ON A PT IT WAS DISCOVERED THAT THE RESERVOIR BAG WAS DEFLATED AND UPON FURTHER INSPECTION IT WAS DETERMINED THAT THE TUBING FROM THE OXYGEN SOURCE WAS NOT CONNECTED TO THE AMBU BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66294 AIRFLOW SMALL ADULT RESUSCITATION AF 5000 SERIES AMBU BAG BTM VENTLAB CORPORATION 105181

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention