BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIRFLOW RESUSCITATION BAG

    MDR report key: 4188125 · Received September 19, 2014

    Report

    Report Number
    2246980-2014-00013
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    July 9, 2013
    Report Date
    September 18, 2014
    Manufacturer
    VENTLAB
    Product Code
    BTM
    PMA / PMN Number
    K012842
    Removal / Correction Number
    RES68242
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS BELATED MDR IS BEING SUBMITTED AS PART OF OUR REMEDIATION REPORTS IN RESPONSE TO THE FDA FORM 483 NOTIFICATION ISSUED ON JUNE 4, 2014 BY (B)(4)TO VENTLAB, LLC. THIS REPORT CONSISTS OF 48 MDR'S. VENTLAB DIDN'T PERFORM INVESTIGATION ON THE AFFECTED DEVICES. HOWEVER, VENTLAB PERFORMED QUALITY TRENDING, PRODUCT INVESTIGATION AND CORRECTIVE ACTIONS TO SOLVE THE ROOT CAUSES. THE SOLUTIONS WERE IMPLEMENTED LAST YEAR AND A RECALL WAS INITIATED IN MAY OF THIS YEAR.

    Description of Event or Problem · 1

    THE PT HAD BRADYCARDIA EVENT FOLLOWED BY CARDIAC ARREST. DURING INITIAL STATES OF REQUIRED RESUSCITATION, STAFF USING BAG WAS MEETING RESISTANCE IA VENTILATION ATTEMPTS. PT HEAD AND JAW, REPOSITIONED STILL MEETING RESISTANCE. CRNA ARRIVED, ALSO UNABLE TO VENTILATE, THE CLINICAL PRESENTATION SUPPORTED THE POSSIBILITY OF AN AIRWAY OBSTRUCTION. CRNA INTUBATED WITH A GLIDASCOPE. STILL DIFFICULT TO VENTILATE WITH BAG. CALLED FOR A SECOND BAG AND VENTILATED EASILY. UPON INSPECTION OF FIRST BAG, THE BUTTERFLY VALVE WAS SEALED SHUT. CRNA APPLIED SIGNIFICANT PRESSURE ON THE BAG AND A LOUD POP WAS HEARD FROM THE BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581220 AIRFLOW RESUSCITATION BAG MANUAL RESUSCITATOR BTM VENTLAB AF5140MB 105877, 105830, 105709, 106253

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention