BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRFLOW

    MDR report key: 5990087 · Received September 30, 2016

    Report

    Report Number
    5990087
    Event Type
    Malfunction
    Date Received
    September 30, 2016
    Date of Event
    August 26, 2016
    Report Date
    August 30, 2016
    Manufacturer
    VENTLAB CORPORATION, LLC
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NV, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PATIENT NEEDED TO BE INTUBATED AT BEDSIDE AND WHILE BEING MANUALLY BAGGED THE AMBU BROKE APART AT THE MASK/BAG CONNECTION SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642557 AIRFLOW VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR) BTM VENTLAB CORPORATION, LLC AF5140MBP 305527

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR