BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRFLOW RESUSCITATION BAG

    MDR report key: 4226790 · Received September 19, 2014

    Report

    Report Number
    2246980-2014-00010
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    June 3, 2013
    Report Date
    September 18, 2014
    Manufacturer
    VENTLAB
    Product Code
    BTM
    PMA / PMN Number
    K012842
    Removal / Correction Number
    RES68242
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    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 JUNE 4, 2014 BY BRIAN M. CAMPBELL TO VENTLAB, LLC. THIS EFFORT CONSISTS OF 48 MDR'S. CUSTOMER DIDN'T RETURN DEVICE FOR INVESTIGATION ADDITIONALLY, VENTLAB PERFORMED QUALITY TRENDING, PRODUCT INVESTIGATION AND CORRECTIVE ACTIONS TO SOLVE THE ROOT CAUSES. THIS IS REFLECTED IN THE EVALUATION. THE SOLUTIONS WERE IMPLEMENTED LAST YEAR AND A RECALL WAS INITIATED IN MAY OF THIS YEAR.

    Description of Event or Problem · 1

    DUCKBILL VALVE STUCK. PRODUCT NOT USED ON PATIENT. DOCTOR WAS DEMONSTRATING. HE PULLED THE BAG OUT AND TRIED TO SQUEEZE IT. THE BAG FILLED BUT HE COULDN'T FORCE AIR OUT OF THE BAG. THE MANOMETER HAD TO GO TO RED BEFORE IT RELEASED AIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581200 AIRFLOW RESUSCITATION BAG MANUAL RESUSCITATOR BTM VENTLAB AF1140MBS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1