BEUDAMED
    FDA Adverse Event Death Summary report: N

    AIRFLOW

    MDR report key: 5924588 · Received September 2, 2016

    Report

    Report Number
    2246980-2016-00038
    Event Type
    Death
    Date Received
    September 2, 2016
    Date of Event
    August 9, 2016
    Report Date
    September 2, 2016
    Manufacturer
    VENTLAB LLC.
    Product Code
    BTM
    PMA / PMN Number
    K012842
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUNMED INVESTIGATED THE AFFECTED DEVICE AND WAS UNABLE TO REPLICATE THE FRACTURE CHARACTERISTICS OF THE STEM FAILURE MODE. DIMENSIONAL AND VISUAL INSPECTION OF THE COMPONENTS AND TOOLS DID NOT INDICATE AN DAMAGE OR EXCESSIVE WEAR. DURING THE INVESTIGATION DIAPHRAGMS WERE INTENTIONALLY DAMAGED, BUT THE PRODUCT STILL PERFORMED AS INTENDED. ADDITIONALLY, WE PERFORMED A HISTORICAL CUSTOMER COMPLAINT REVIEW (EXTERNAL DATA) AND A NONCONFORMING PRODUCT REVIEW (INTERNAL DATA) AND FOUND NO OCCURRENCES OF THIS FAILURE MODE. WE HAVE NOT BEEN ABLE TO DETERMINE THE ROOT CAUSE AND CONSIDER THIS TO BE AN ISOLATED INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES " AIR WAS ESCAPING FROM THE BACK OF THE RESUS BAG AND WAS NOT BEING DELIVERED THROUGH THE MASK TO THE PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577447 AIRFLOW RESUS BAG BTM VENTLAB LLC. AF5140MB-S

    Patients

    Seq Age Sex Outcome Treatment
    1 Death