BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTLAB HYPERINFLATION SYSTEM FEATURING BUILT IN PRESSURE MONITOR

    MDR report key: 6275708 · Received January 19, 2017

    Report

    Report Number
    MW5067432
    Event Type
    Malfunction
    Date Received
    January 19, 2017
    Date of Event
    January 11, 2017
    Report Date
    January 19, 2017
    Manufacturer
    VENTLAB CORPORATION
    Product Code
    NHK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING A SIMULATOR EVENT, THE PHYSICIAN WAS "BAGGING" THE INFANT SIMULATOR AND THE DISPOSABLE ANESTHESIA BAG RUPTURED. THE BAG WAS OVER INFLATED, THE FLOW THROUGH THE BAG FROM THE O2 SOURCE WAS BETWEEN 10-15 LPM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48701 VENTLAB HYPERINFLATION SYSTEM FEATURING BUILT IN PRESSURE MONITOR VENTLAB HYPERINFLATION SYSTEM FEATURING BUILT IN PRESSURE MONITOR NHK VENTLAB CORPORATION HS4051 303501

    Patients

    Seq Age Sex Outcome Treatment
    1