BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTLAB

    MDR report key: 2948829 · Received January 30, 2013

    Report

    Report Number
    MW5028839
    Event Type
    Injury
    Date Received
    January 30, 2013
    Date of Event
    December 27, 2012
    Report Date
    January 30, 2013
    Manufacturer
    VENTLAB CORPORATION
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE CLEAR TUBING OF THE AIRFLOW INFANT RESUSCITATOR BECAME SEPARATED FROM THE GREEN ELBOW THAT CONNECTS TO THE AMBUBAG. TUBING RECONNECTED TO THE ELBOW AND PT SPO2 STILL DOES NOT IMPROVE. ETT PULLED AND BVM RESUMED, SPO2 INCREASES, PLACED BACK ON HFNC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41268 VENTLAB AIRFLOW INFANT RESUSCITATOR AF 3000 SERIES BTM VENTLAB CORPORATION AF3140MB 100752

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Required Intervention