BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENVE

    MDR report key: 2071543 · Received April 19, 2011

    Report

    Report Number
    2071543
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 27, 2011
    Report Date
    April 19, 2011
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    DURING AIR TRANSPORT THE ENVE VENTILATOR COULD NOT MAINTAIN PRESSURE SUPPORT. LOW POSITIVE END-EXPIRATORY PRESSURE (PEEP) ALARMS COULD NOT BE RESOLVED DUE TO FREQUENT VENTILATOR CIRCUIT DISCONNECTIONS. VENTILATOR CIRCUIT CONTINUED TO DISCONNECT THROUGHOUT ENTIRE FLIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENVE VENTILATOR CBK CAREFUSION ENVI *

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR