BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIRFLOW RESUSCITATION BAG

    MDR report key: 4188119 · Received September 19, 2014

    Report

    Report Number
    2246980-2014-00018
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    September 13, 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
    KS, 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. THE AFFECTED DEVICE WAS NOT RETURNED FOR INVESTIGATION. 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

    DURING PT USE. THE RUBBER DUCKBILL VALVE IS SEALED SHUT WHICH WILL NOT ALLOW THE BAG TO FUNCTION WITH SQUEEZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581218 AIRFLOW RESUSCITATION BAG MANUAL RESUSCITATOR BTM VENTLAB AF1140MB 106237

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention