BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRFLOW RESUSCITATION BAG

    MDR report key: 4381115 · Received December 2, 2014

    Report

    Report Number
    2246980-2014-00053
    Event Type
    Malfunction
    Date Received
    December 2, 2014
    Date of Event
    September 24, 2014
    Report Date
    December 1, 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
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE AFFECTED DEVICE WAS RETURNED FOR INVESTIGATION; HOWEVER, WE COULD NOT REPRODUCE THE STUCK DUCKBILL REPORT. THE VALVE OPENED 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

    THE VALVE WAS STUCK AND WOULD NOT VENTILATE PT. INITIALLY TOOK A LOT OF PRESSURE TO VENTILATE THE PT, BUT THEN WORKED FINE. NO DEATH OR SERIOUS INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779164 AIRFLOW RESUSCITATION BAG BTM VENTLAB CORP. 206211

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention