BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRFLOW ADULT RESUSCITATOR

    MDR report key: 3131583 · Received May 24, 2013

    Report

    Report Number
    3131583
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    February 6, 2013
    Report Date
    May 23, 2013
    Manufacturer
    VENTLAB CORPORATION
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US

    Narratives

    Description of Event or Problem · 1

    DURING AN INTUBATION, THE BAG CAME APART AT THE PLACE WHERE THE BAG CONNECTS TO THE TUBING.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231242 AIRFLOW ADULT RESUSCITATOR BAG, RESERVOIR BTM VENTLAB CORPORATION * 103739

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR