BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYPERINFLATION SYSTEM

    MDR report key: 1771362 · Received July 9, 2010

    Report

    Report Number
    1771362
    Event Type
    Malfunction
    Date Received
    July 9, 2010
    Date of Event
    May 25, 2010
    Report Date
    July 9, 2010
    Manufacturer
    VENTLAB CORPORATION
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    VENTLAB HYPERINFLATION SYSTEMS AMBU BAG WOULD NOT MAINTAIN ADEQUATE POSITIVE END-EXPIRATORY PRESSURE (PEEP) DURING POSITIVE PRESSURE VENTILATION (PPV) VIA BAG/MASK. FLOW METER WAS CORRECTLY SET AT 10 LITERS PER MINUTE (LPM). PRESSURE RELIEF VALVE HAD TO BE SET AT OVER 20 POUNDS PER SQUARE INCH (PSI) TO GIVE EFFECTIVE PPV. DELAY IN BEING ABLE TO GIVE ADEQUATE VENTILATION RESULTED IN CHEST COMPRESSIONS BECOMING NECESSARY. NEONATOLOGIST WAS AT BEDSIDE DURING EVENT.======================MANUFACTURER RESPONSE FOR AMBU BAG, VENTLAB HYPERIN======================INCIDENT REPORTED TO VENDOR. PRODUCT QUALITY FORM COMPLETED FOR VENDOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYPERINFLATION SYSTEM VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR) BTM VENTLAB CORPORATION HS4051 87027

    Patients

    Seq Age Sex Outcome Treatment
    1 *