BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRFLOW RESUSCITATION BAG

    MDR report key: 4392371 · Received September 19, 2014

    Report

    Report Number
    2246980-2014-00025
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    November 4, 2013
    Report Date
    September 19, 2014
    Manufacturer
    VENTLAB
    Product Code
    BTM
    PMA / PMN Number
    K012842
    Removal / Correction Number
    RES68242
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS BELATED MDR IS BEING SUBMITTED AS PART OF OUR REMEDIATION EFFORTS IN RESPONSE TO THE FDA FORM 483 NOTIFICATION ISSUED ON 06/04/2014 BY (B)(4) TO VENTLAB, LLC. THIS EFFORT CONSIST OF 49 MDR'S. THE AFFECTED DEVICE WAS NOT INVESTIGATED. HOWEVER, VENTLAB PERFORMED QUALITY TRENDING, PRODUCT INVESTIGATION AND CORRECTIVE ACTIONS TO SOLVE THE ROOT CAUSES. (B)(4). THE SOLUTIONS WERE IMPLEMENTED LAST YEAR AND A RECALL WAS INITIATED IN MAY OF THIS YEAR.

    Description of Event or Problem · 1

    WE BECAME AWARE OF AN ISSUE BY A SYSTEM HOSP THAT THEY FOUND A DUCK VALVE THAT GOT STUCK WHILE TRYING TO USE A RESUSCITATION BAG VALVE MASK - WE CHECKED OUR SUPPLIES AND FOUND (B)(4) DEFECTIVE VALVES. WITH SOME EXTRA PRESSURE THE VALVE WILL RELEASE, BUT IN A CODE SITUATION THESE VALVES COULD POSE A RISK. LOTS INVOLVED INCLUDED LOT#'S: 106564, 106003, 105157, 107509, 99301, 101304, 98820, 86341, 85521, 83709, 79475, 76380.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585547 AIRFLOW RESUSCITATION BAG MANUAL RESUSCITATOR BTM VENTLAB AF1000 106564, 106003, 105157, 107509

    Patients

    Seq Age Sex Outcome Treatment
    1