BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIRFLOW RESUSCITATION BAG

    MDR report key: 4188101 · Received September 19, 2014

    Report

    Report Number
    2246980-2014-00008
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    April 29, 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
    AL, 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. CUSTOMER RETURNED ALL PRODUCT FOR INVESTIGATION AND MALFUNCTION WAS CONFIRMED. BREAKDOWN: (B)(4) UNITS OPENED IMMEDIATELY, (B)(4) OPENED WITH LESS THAN 40CMH2O PRESSURE, AND (B)(4) OPENED WITH MORE THAN 40CMH2O OF PRESSURE. ADDITIONALLY, 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 DUCKBILL VALVE INSIDE THE PT VALVE IS STUCK UPON FIRST INITIAL USE. VALVE CAN USUALLY BE FORCEFULLY BLOWN OPEN BY A HARD SQUEEZE OF BAG. ONCE OPEN IT APPEARS TO FUNCTION PROPERLY. SOME VALVES ARE HARDER TO OPEN THAN OTHERS. REPORTED NO INJURY OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581087 AIRFLOW RESUSCITATION BAG MANUAL RESUSCITATOR BTM VENTLAB AF1140MB-P 105579, 106003, 106564

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention