BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRFLOW

    MDR report key: 6057746 · Received October 26, 2016

    Report

    Report Number
    2246980-2016-00060
    Event Type
    Malfunction
    Date Received
    October 26, 2016
    Date of Event
    September 19, 2016
    Report Date
    September 29, 2016
    Manufacturer
    VENTLAB LLC.
    Product Code
    BTM
    PMA / PMN Number
    K012842
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710047 AIRFLOW RESUS BAG BTM VENTLAB LLC. AF5140MB 306202

    Patients

    Seq Age Sex Outcome Treatment
    1