BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRFLOW

    MDR report key: 2694150 · Received August 3, 2012

    Report

    Report Number
    2246980-2012-00008
    Event Type
    Malfunction
    Date Received
    August 3, 2012
    Date of Event
    July 9, 2012
    Report Date
    July 13, 2012
    Manufacturer
    VENTLAB CORP.
    Product Code
    BTM
    PMA / PMN Number
    K012842
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L LOT #S: 101222, 102127. THE ACTUAL DEVICE WAS NOT RETURNED FOR OUR INVESTIGATION. THREE UNUSED SAMPLES FROM THREE DIFFERENT LOTS (99743, 101222 AND 102127) WERE RETURNED INSTEAD. THESE SAMPLES WERE EVALUATED AND RESULTS ARE AS FOLLOWS: SAMPLE 1 (LOT 99743) THE PT VALVE WAS TESTED AND FOUND TO FUNCTION PROPERLY; SAMPLE 2 (LOT 102127) THE PT VALVE WAS TESTED AND FOUND TO FUNCTION PROPERLY, HOWEVER, WE FOUND THAT IT HOUSED AN UNSPECIFIED VALVE. THIS LOT IS CURRENTLY UNDER RECALL FOR THE UNSPECIFIED VALVE. SAMPLE 3 (LOT 101222) THE PT VALVE WAS TESTED AND FOUND TO FUNCTION PROPERLY, HOWEVER THE INLET DIAPHRAGM VALVE LEAKED SEVERELY. THIS LOT IS ALSO CURRENTLY UNDER RECALL FOR THE UNSPECIFIED VALVE.

    Description of Event or Problem · 1

    EVENT DESC: THE MANOMETER IS NOT GIVING PROPER PRESSURE READINGS WHEN USED WITH INFANTS. THIS HAS HAPPENED SPORADICALLY WITH THREE DIFFERENT LOT NUMBERS OF INFANT RESUSCITATION BAG (CAT # VN3140MB, 87AF3140MB2). THE NICU MANAGER DESCRIBES THE MALFUNCTION AS AN INABILITY TO DELIVER THE AIR PRESSURE "LIKE A VALVE ISN'T OPENED". THE MANOMETER AND INFANT RESUSCITATION BAG APPEAR TO BE IN WORKING ORDER JUST BEFORE USE, BUT WHEN ACTUALLY APPLIED TO THE INFANT'S MOUTH, THERE DOESN'T FELL LIKE ANY PRESSURE IS BEING ADMINISTERED. THERE IS NO MANOMETER FUNCTION. DEVICE USAGE PROBLEM: DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IS WAS SUPPOSED TO DO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIRFLOW BAG, RESUSCITATION BTM VENTLAB CORP. AF3140MB-2 99743

    Patients

    Seq Age Sex Outcome Treatment
    1 Other