BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVEA

    MDR report key: 5074153 · Received September 14, 2015

    Report

    Report Number
    5074153
    Event Type
    Malfunction
    Date Received
    September 14, 2015
    Date of Event
    March 28, 2015
    Report Date
    August 19, 2015
    Manufacturer
    CAREFUSION 211 INC DBA CAREFUSION
    Product Code
    CBK
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RN AND NA WERE IN THE ROOM AT THE TIME OF THE INCIDENT. RN STATED TO RT THAT THE "VENTILATOR WAS BROKEN". RT OBSERVED FROZEN SCREEN AND NO VENTILATION FROM THE VENTILATOR. PATIENT WAS BEING MANUALLY VENTILATED BY RN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604812 AVEA VENTILATOR, CONTINUOUS, FACILITY USE CBK CAREFUSION 211 INC DBA CAREFUSION

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR