BEUDAMED
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    CareFusion EnVe Ventilator Designed for use on patients who require respiratory support or mechanical ventilation and weigh a minimum of 5 kg (11 lbs). It is suitable for service in hospital and transport environments as a source of continuous or intermittent positive pressure ventilatory support, delivered invasively or non-invasively. It is not intended for homecare use.

    FDA Enforcement
    Class I ·Terminated·CareFusion 203, Inc.·July 25, 2012

    CareFusion EnVe and ReVel Ventilators. The EnVe/ ReVel Ventilator is designed for use on patients who require respiratory support or mechanical ventilation and weigh a minimum of 5 kg (11 lbs.). It is suitable for service in hospital, transport and homecare as a source of continuous or intermittent positive pressure ventilator support, delivered invasively or non-invasively. These ventilators are restricted medical devices intended for operation by a trained personnel under the direction of a physician and in accordance with all applicable state laws and regulations.

    FDA Enforcement
    Class I ·Terminated·CareFusion 203, Inc.·October 1, 2014

    LTV 1200 VENTILATOR

    FDA Adverse Event
    Malfunction ·CAREFUSION 203, INC·Product code CBK·November 16, 2016

    LTV

    FDA Adverse Event
    Death ·CAREFUSION 203, INC·Product code CBK·September 10, 2015

    LTV

    FDA Adverse Event
    Malfunction ·CAREFUSION 203, INC·Product code CBK·July 8, 2015

    LTV

    FDA Adverse Event
    Malfunction ·CAREFUSION 203, INC·Product code CBK·September 17, 2015

    REVEL

    FDA Adverse Event
    Malfunction ·CAREFUSION 203, INC·Product code CBK·August 5, 2015

    LTV

    FDA Adverse Event
    Malfunction ·CAREFUSION 203, INC·Product code CBK·August 21, 2015

    REVEL

    FDA Adverse Event
    Malfunction ·CAREFUSION 203, INC·Product code CBK·August 21, 2015

    REVEL

    FDA Adverse Event
    Malfunction ·CAREFUSION 203, INC·Product code CBK·September 24, 2015

    REVEL

    FDA Adverse Event
    Malfunction ·CAREFUSION 203, INC·Product code CBK·August 26, 2015

    LTV

    FDA Adverse Event
    Malfunction ·CAREFUSION 203, INC·Product code CBK·August 20, 2015

    REVEL

    FDA Adverse Event
    Injury ·CAREFUSION 203, INC·Product code CBK·September 16, 2015

    LTV

    FDA Adverse Event
    Injury ·CAREFUSION 203, INC·Product code CBK·August 5, 2015

    LTV

    FDA Adverse Event
    Malfunction ·CAREFUSION 203, INC·Product code CBK·July 10, 2015

    LTV

    FDA Adverse Event
    Injury ·CAREFUSION 203, INC·Product code CBK·August 28, 2015

    LTV

    FDA Adverse Event
    Malfunction ·CAREFUSION 203, INC·Product code CBK·September 10, 2015

    ENVE

    FDA Adverse Event
    Malfunction ·CAREFUSION 203, INC·Product code CBK·July 15, 2015

    LTV

    FDA Adverse Event
    Death ·CAREFUSION 203, INC·Product code CBK·September 17, 2015

    LTV

    FDA Adverse Event
    Malfunction ·CAREFUSION 203, INC·Product code CBK·July 15, 2015