BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIRFLOW RESUSCITATION BAG

    MDR report key: 4188118 · Received September 19, 2014

    Report

    Report Number
    2246980-2014-00017
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    September 5, 2013
    Report Date
    September 18, 2014
    Manufacturer
    VENTLAB
    Product Code
    BTM
    PMA / PMN Number
    K012842
    Removal / Correction Number
    RES68242
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS BELATED MDR IS BEING SUBMITTED AS PART OF OUR REMEDIATION REPORTS IN RESPONSE TO THE FDA FORM 483 NOTIFICATION ISSUED ON JUNE 4, 2014 BY (B)(4) TO VENTLAB, LLC. THIS REPORT CONSISTS OF 48 MDR'S. IT WAS CONFIRMED THAT THE BANG WOULD NOT DEFLATE BECAUSE THE PT VALVE HAD A STUCK DUCKBILL. THE DUCKBILL BECAME UNSTUCK DURING THE INVESTIGATION BUT IT TOOK 80CMH2O OF PRESSURE TO OPEN THE VALVE. ADDITIONALLY, 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

    DURING PT USE THE BAG WOULD NOT DEFLATE. NO SERIOUS INJURY OR DEATH REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581084 AIRFLOW RESUSCITATION BAG MANUAL RESUSCITATOR BTM VENTLAB AF5140MB 200221

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention