BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRFLOW

    MDR report key: 6105392 · Received November 16, 2016

    Report

    Report Number
    2246980-2016-00071
    Event Type
    Malfunction
    Date Received
    November 16, 2016
    Date of Event
    October 6, 2016
    Report Date
    October 20, 2016
    Manufacturer
    VENTLAB LLC.
    Product Code
    BTM
    PMA / PMN Number
    K012842
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES " THE MASK IS DIFFICULT TO REMOVE FROM THE RESUS BAG." NO OTHER DETAILS WERE PROVIDED AND NO PATIENT INJURY/HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758655 AIRFLOW RESUS BAG BTM VENTLAB LLC. AF1140MB-P 304948

    Patients

    Seq Age Sex Outcome Treatment
    1