BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRFLOW

    MDR report key: 5990090 · Received September 30, 2016

    Report

    Report Number
    5990090
    Event Type
    Malfunction
    Date Received
    September 30, 2016
    Date of Event
    August 25, 2016
    Report Date
    August 30, 2016
    Manufacturer
    VENTLAB CORPORATION
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT NEEDED TO BE INTUBATED AT BEDSIDE AND AMBU BAG BROKE APART AT THE MASK CONNECTOR SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642556 AIRFLOW VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR) BTM VENTLAB CORPORATION AF5140MBP 3055277

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR