BEUDAMED
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    Trilogy Ventilators The Respironics Trilogy 100 system provides continuous or intermittent ventilator support for the care of individuals who require mechanical ventilation. Trilogy 100 is intended for pediatric through adult patients weighing at least 5 kg (11 lbs.). The device is intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used for both invasive and non-invasive ventilation. It is not intended to be used as a transport ventilator. Trilogy 200 Intended Use: The Respironics Trilogy 200 system provides continuous or intermittent ventilator support for the care of individuals who require mechanical ventilation. Trilogy 200 is intended for pediatric through adult patients weighing at least 5 kg (11 lbs.). The device is intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used for both invasive and non-invasive ventilation. Trilogy 202 Intended Use: The Respironics Trilogy 202 system provides continuous or intermittent ventilator support for the care of individuals who require mechanical ventilation with or without air/oxygen blending. Trilogy 202 is intended for pediatric through adult patients weighing at least 5 kg (11 lbs.). The device is intended to be used in hospitals and institutions, and for portable applications such as wheelchairs and gurneys only when in an institutional setting. It may be used for both invasive and non-invasive ventilation. It is not intended to be used as a transport ventilator.

    FDA Recall
    Terminated ·Phillips Respironics, Inc.·Product code CBK·February 11, 2014

    Trilogy Ventilators The Respironics Trilogy 100 system provides continuous or intermittent ventilator support for the care of individuals who require mechanical ventilation. Trilogy 100 is intended for pediatric through adult patients weighing at least 5 kg (11 lbs.). The device is intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used for both invasive and non-invasive ventilation. It is not intended to be used as a transport ventilator. Trilogy 200 Intended Use: The Respironics Trilogy 200 system provides continuous or intermittent ventilator support for the care of individuals who require mechanical ventilation. Trilogy 200 is intended for pediatric through adult patients weighing at least 5 kg (11 lbs.). The device is intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used for both invasive and non-invasive ventilation. Trilogy 202 Intended Use: The Respironics Trilogy 202 system provides continuous or intermittent ventilator support for the care of individuals who require mechanical ventilation with or without air/oxygen blending. Trilogy 202 is intended for pediatric through adult patients weighing at least 5 kg (11 lbs.). The device is intended to be used in hospitals and institutions, and for portable applications such as wheelchairs and gurneys only when in an institutional setting. It may be used for both invasive and non-invasive ventilation. It is not intended to be used as a transport ventilator.

    FDA Enforcement
    Class I ·Terminated·Phillips Respironics, Inc.·March 12, 2014

    PHILLIPS RESPIRONICS DREAMSTATION AUTO CPAP

    FDA Adverse Event
    Injury ·PHILLIPS / RESPIRONICS, INC.·Product code BZD·June 25, 2021

    TRILOGY EVO

    FDA Adverse Event
    Malfunction ·PHILLIPS / RESPIRONICS INC.·Product code CBK·April 20, 2021

    DREAM STATION AUTO CPAP

    FDA Adverse Event
    Injury ·PHILLIPS / RESPIRONICS INC.·Product code BZD·June 24, 2021

    DREAM STATION 2 CPAP MACHINE

    FDA Adverse Event
    Injury ·PHILLIPS/RESPIRONICS INC.·Product code BZD·January 26, 2023

    DREAMSTATION 2

    FDA Adverse Event
    Malfunction ·PHILLIPS/RESPIRONICS, INC.·Product code BZD·May 17, 2024

    DREAM STATION 2 AUTO CPAP ADVANCED

    FDA Adverse Event
    Malfunction ·PHILLIPS/RESPIRONICS, INC·Product code BZD·September 5, 2023

    SYSTEM ONE BIPAP

    FDA Adverse Event
    Injury ·PHILLIPS / RESPIRONICS INC.·Product code MNS·July 2, 2020

    TRILOGY EVO

    FDA Adverse Event
    Malfunction ·PHILLIPS/RESPIRONICS INC.·Product code CBK·April 24, 2024

    CPAP MACHINE

    FDA Adverse Event
    Injury ·PHILLIPS / RESPIRONICS INC.·Product code BZD·June 17, 2024

    DREAM STATION

    FDA Adverse Event
    Malfunction ·PHILLIPS / RESPIRONICS INC.·Product code BZD·June 29, 2022

    DREAM MACHINE 2 CPAP

    FDA Adverse Event
    Injury ·PHILLIPS / RESPIRONICS INC.·Product code BZD·September 18, 2023

    DREAM STATION 2 CPAP AUTO CPAP ADVANCED

    FDA Adverse Event
    Malfunction ·PHILLIPS/RESPIRONICS INC.·Product code BZD·September 4, 2025

    DREAMSTATIONSTNAUTOCPAPHUMCELL DOM DREAMSTATION STN AUTO CPAP HUM CELL DOM

    FDA Adverse Event
    Injury ·PHILLIPS / RESPIRONICS INC·Product code BZD·July 20, 2021

    PHILLIPS DREAMSTATION

    FDA Adverse Event
    Malfunction ·PHILLIPS / RESPIRONICS, INC.·Product code BZD·July 7, 2021

    DREAMSTATION CPAP

    FDA Adverse Event
    Injury ·PHILLIPS / RESPIRONICS, INC.·Product code BZD·July 7, 2021

    PHILLIPS RESPIRONICS DREAMSTATION

    FDA Adverse Event
    Injury ·PHILLIPS / RESPIRONICS, INC.·Product code BZD·August 3, 2021

    PHILLIPS DREAM STATION

    FDA Adverse Event
    Injury ·PHILLIPS / RESPIRONICS, INC.·Product code BZD·July 7, 2021

    DREAMSTATION

    FDA Adverse Event
    Malfunction ·PHILLIPS / RESPIRONICS INC.·Product code BZD·July 6, 2021