BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRFLOW RESUSCITATION BAG

    MDR report key: 4381116 · Received December 2, 2014

    Report

    Report Number
    2246980-2014-00054
    Event Type
    Malfunction
    Date Received
    December 2, 2014
    Date of Event
    October 29, 2014
    Report Date
    December 1, 2014
    Manufacturer
    VENTLAB CORP.
    Product Code
    BTM
    PMA / PMN Number
    K012842
    Removal / Correction Number
    RES68242
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE AFFECTED DEVICE WAS RETURNED FOR INVESTIGATION. WE CONFIRMED THAT THE DUCKBILL VALVE WAS PARTIALLY OPENED. THIS DEVICE WAS STILL ABLE TO PROVIDE ENOUGH AIR THAT THE DEVICE FUNCTIONED AS INTENDED. VENTLAB PERFORMED QUALITY TRENDING, PRODUCT INVESTIGATION AND CORRECTIVE ACTIONS TO SOLVE THE ROOT CAUSES. A RECALL WAS INITIATED IN MAY OF THIS YEAR.

    Description of Event or Problem · 1

    CUSTOMER NOTICED OUT OF BOX THAT DUCKBILL VALVE WAS PARTIALLY OPEN. NO PT ISSUE. NO DEATH OR SERIOUS INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779210 AIRFLOW RESUSCITATION BAG BTM VENTLAB CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1