BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENVE

    MDR report key: 2082700 · Received April 27, 2011

    Report

    Report Number
    2031702-2011-00089
    Event Type
    Injury
    Date Received
    April 27, 2011
    Date of Event
    March 26, 2011
    Report Date
    April 27, 2011
    Manufacturer
    CAREFUSION 203, INC.
    Product Code
    CBK
    PMA / PMN Number
    K070594
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN PREPARATION FOR PATIENT TRANSFER FROM THE HOSPITAL, THE PATIENT WAS PLACED ON THE VENTILATOR WITH THE "SAME" SETTINGS AS THE HOSPITAL VENTILATOR. SHORTLY AFTER, THE PATIENT STATED THEY WERE NOT GETTING ENOUGH AIR. WHEN THE VENTILATOR WAS PLACED IN STANDBY MODE AND RESTARTED, FLOW APPEARED TO INCREASE TO THE PATIENT. THE TRANSPORT WAS COMPLETED WITH MANUAL VENTILATION. THE PATIENT STATUS WAS REPORTED AS OK. DURING TRANSPORT, THE BATTERY DURATION PERIOD WAS SHORTENED. WHEN THE BATTERY WAS REMOVED FOR REPLACEMENT, THE DEVICE STOPPED DELIVERING VENTILATION. WHEN THE REPLACEMENT BATTERY WAS INSTALLED, VENTILATION RESUMED. THE PATIENT CIRCUIT "POPPED OFF" FROM THE CONNECTOR PORT DURING TRANSPORT AND REQUIRED RECONNECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENVE VENTILATOR, CONTINUOUS / CBK CBK CAREFUSION 203, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention