BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIRFLOW RESUSCITATION BAG

    MDR report key: 4151573 · Received October 2, 2014

    Report

    Report Number
    2246980-2014-00042
    Event Type
    Injury
    Date Received
    October 2, 2014
    Date of Event
    June 28, 2013
    Report Date
    October 2, 2014
    Manufacturer
    VENTLAB CORP.
    Product Code
    BTM
    PMA / PMN Number
    K012842
    Removal / Correction Number
    RES68242
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    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 (B)(4) TO VENTLAB, LLC. THIS EFFORT CONSISTS OF (B)(4) 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

    THE DUCKBILL VALVE ON THE RESUSCITATION BAG IS STUCK. DURING PATIENT USE. NO DEATH OR SERIOUS INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615459 AIRFLOW RESUSCITATION BAG MANUAL RESUSCITATOR BTM VENTLAB CORP. VN5000MBPF-I 105155, 106531

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention