BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRFLOW RESUSCITATION BAG

    MDR report key: 4148234 · Received September 30, 2014

    Report

    Report Number
    2246980-2014-00035
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Date of Event
    July 17, 2013
    Report Date
    September 30, 2014
    Manufacturer
    VENTLAB
    Product Code
    BTM
    PMA / PMN Number
    K012842
    Removal / Correction Number
    RES68242
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS RELATED MDR IS BEING SUBMITTED AS PART OF OUR REMEDIATION EFFORTS IN RESPONSE TO THE FDA FORM 483 NOTIFICATION ISSUED ON JUNE 4, 2014 BY (B)(4) TO VENTLAB, LLC. THIS EFFORT CONSISTS OF 48 MDR'S. THE AFFECTED DEVICE WAS NOT INVESTIGATED. 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

    DISTRIBUTOR SALES REP REPORTED THAT HIS ACCOUNT HAS FIVE BAGS WITH STICKING DUCKBILL VALVES. NO DEATH OR SERIOUS INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607220 AIRFLOW RESUSCITATION BAG MANUAL RESUSCITATOR BTM VENTLAB

    Patients

    Seq Age Sex Outcome Treatment
    1