BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRFLOW

    MDR report key: 6995691 · Received November 2, 2017

    Report

    Report Number
    2246980-2017-00028
    Event Type
    Malfunction
    Date Received
    November 2, 2017
    Date of Event
    October 2, 2017
    Report Date
    October 4, 2017
    Manufacturer
    VENTLAB LLC.
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RETURNED TWO SKIDS OF PRODUCT. ENGINEERING PULLED SEVERAL SAMPLES THROUGHOUT THE LOT OF RETURNED PRODUCT AND CONFIRMED THE CUSTOMERS FINDING. THE MASK PORT IS DEFORMED TO THE POINT THAT IT WILL NO LONGER MATE WITH THE MANOMETER PATIENT PORT.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT THERE IS A "THE MASK VALVE WAS WAS OVAL/OBLONG SHAPED AND NOT ROUND AS IT SHOULD BE. THE MASK WOULD NOT CONNECT TO THE BAG. " NO OTHER DETAILS WERE PROVIDED AND NO PATIENT INJURY/HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776403 AIRFLOW RESUS BAG BTM VENTLAB LLC. AF5140MB 310488

    Patients

    Seq Age Sex Outcome Treatment
    1