BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRFLOW ADULT RESUSCITATOR WITH BUILT-IN PRESSURE MONITOR

    MDR report key: 730225 · Received June 21, 2006

    Report

    Report Number
    730225
    Event Type
    Malfunction
    Date Received
    June 21, 2006
    Date of Event
    June 15, 2006
    Report Date
    June 21, 2006
    Manufacturer
    VENTLAB CORPORATION
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    RESPIRATORY THERAPY WAS ATTEMPTING TO INTUBATE PATIENT WITH SEVERE RESPIRATORY DISTRESS AND ASTHMA. PATIENT WAS CYANOTIC. THE FACE MASK BROKE OFF THE AMBU BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIRFLOW ADULT RESUSCITATOR WITH BUILT-IN PRESSURE MONITOR RESUSCITATOR BTM VENTLAB CORPORATION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR