BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRFLOW

    MDR report key: 2755832 · Received September 19, 2012

    Report

    Report Number
    2246980-2012-00010
    Event Type
    Malfunction
    Date Received
    September 19, 2012
    Date of Event
    August 2, 2012
    Report Date
    August 14, 2012
    Manufacturer
    VENTLAB CORPORATION
    Product Code
    BTM
    PMA / PMN Number
    K012542
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE HAS NOT BEEN RETURNED FOR EVAL. ATTEMPTS ARE IN PROGRESS TO GET THE DEVICE RETURNED FOR INVESTIGATION. THE LOT NUMBER INVOLVED IS CURRENTLY UNDER A VOLUNTARY RECALL. THE RESULTS OF THE EVAL FOUND THAT THE GAS VOLUME FROM THE RESUSCITATOR, WHEN THE BAG WAS COMPRESSED, WAS LEAKING AROUND THE INLET VALVE. THE INLET VALVE IS DESIGNED TO CLOSE AND SEAL WHEN THE BAG IS COMPRESSED AND OPENS ALLOWING GAS TO RE-ENTER THE BAG AFTER A BAG COMPRESSION, ALSO KNOWN AS BAG RECOIL. IT WAS FOUND THAT DELIVERED VOLUME WAS DEPENDENT UPON TECHNIQUE OF BAG COMPRESSION. DEPENDING UPON THE TECHNIQUE USED, SUITABLE VOLUME COULD BE DELIVERED AND ANOTHER TECHNIQUE WOULD PRODUCE LESS THAN THE EXPECTED VOLUME DELIVERY. FURTHER INVESTIGATION OF THE INLET VALVE FOUND THAT IT DID NOT MEET THE SPECIFICATIONS FOR THAT LOCATION OF THE VALVE.

    Description of Event or Problem · 1

    WHILE BAGGING THE INFANT, THE PHYSICIAN NOTED THAT PT WAS ONLY ABLE TO BAG WITH A PRESSURE OF "10" EVEN WITH THE POP OFF VALVE OCCLUDED. THE INFANT RESUSCITATION BAG ONLY GIVES PRESSURE SPORADICALLY. YOU CAN NOT COUNT ON THEM TO GIVE THE BREATH YOU NEED. DEVICE USAGE PROBLEM: DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIRFLOW BAG, RESUSCITATION, INFANT BTM VENTLAB CORPORATION AF3140MB 102168

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Other