BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTLAB AIRFLOW SMALL ADULT RESUSCITATOR

    MDR report key: 2246600 · Received September 7, 2011

    Report

    Report Number
    2246980-2011-00003
    Event Type
    Injury
    Date Received
    September 7, 2011
    Date of Event
    June 29, 2011
    Report Date
    September 7, 2011
    Manufacturer
    VENTLAB CORPORATION
    Product Code
    BTM
    PMA / PMN Number
    012842
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE DID NOT FUNCTION PROPERLY. THE INLET DIAPHRAGM VALVE HAD BECOME DISLODGED FROM ITS HOUSING. BOTH THE VALVE AND HOUSING WERE INTACT. IT IS UNK AND INCONCLUSIVE AS TO HOW THE VALVE BECAME DISLODGED FROM ITS HOUSING. PRODUCTION BATCH RECORDS INDICATE NO ISSUES RELATIVE TO BAG OPERATION IN ITS 100% PERFORMANCE TESTING.

    Description of Event or Problem · 1

    AS REPORTED BY THE EMS CHIEF: WHILE TREATING A PT IN CARDIAC ARREST WE WERE ATTEMPTING TO VENTILATE THE PT'S AIRWAY WITH A BAG VALVE MASK (BVM). THE EQUIPMENT IS STORED IN OUR ALS BAG AND IS STORED WITHIN THE MANUFACTURERS PACKAGING. THE BVM WAS NOTED TO NOT BE FORCING AIR OUT IN THE NORMAL PATHWAY TO THE PT. THE APPARENT FAILURE IS THE DISLODGEMENT OF THE ON-WAY VALVE AT THE INLET SIDE OF THE BVM WHICH REMAINED WITHIN THE BAG PORTION OF THE DEVICE. THIS DID NOT ALLOW THE AIR TO FLOW IN A SINGLE DIRECTION TO THE PT BUT INSTEAD ALLOWED IT TO FLOW TO THE PATH OF LEAST RESISTANCE WHICH IN THIS CASE WAS AWAY FROM THE PT AND DOWN THE CORRUGATED RESERVOIR TUBING. THE BACK-UP BVM CARRIED ON THE UNIT WAS PLACED IN SERVICE AS SOON AS IT WAS RECOGNIZED THAT IT WAS THE BVM THAT WAS FAILING AS OPPOSED TO INCORRECT PLACEMENT OR TUBE OBSTRUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTLAB AIRFLOW SMALL ADULT RESUSCITATOR EMERGENCY MANUAL RESUSCITATOR BTM VENTLAB CORPORATION AF5140MC 80005

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention