With BARDA's continuing support, Philips finally won FDA approval for the Trilogy Evo Universal ventilator in July 2019. Invasive/noninvasive ventilation for patients 5kg and above, Auto-adaptive technology can help patient synchrony and therapy acceptance, Up to six hours* of battery life supports portability, Bluetooth connectivity options along with optional SpO2 monitoring, Single limb (Passive, Active PAP, Active Flow). Do not use any quarantined material and contact Philips for return instructions. The process for initiation and ongoing evaluation of the effectiveness of mechanical ventilation using a Trilogy Evo via an artificial airway in the inpatient setting. Easy access to data Identify all of the impacted devices purchased by your organization. The FDA continues to review and assess the MDRs and will keep the public informed as new information becomes available. Eight of those reports were from the U.S. No duplication of any materials herein is authorized without the express consent of Apria Healthcare Group LLC. These Philips Trilogy 100 and Trilogy 2000 ventilators were a part of this recall in June 2021 for issues with the polyester-based polyurethane (PE-PUR) sound abatement foam breakdown. If you have a health issue, including those listed under potential health risks below, or any problem with your device, talk to your health care provider and. Trilogy Evo is designed for easy navigation and fast set-up of prescriptions. If you have a health issue, including any of the health issues listed above, or any problem with your device, the FDA encourages you to talk to your health care provider and report the problem through the MedWatch Voluntary Reporting Form. There have been no reported injuries or death to date. The PE-PUR foam used in the recalled devices may break down and can result in serious injury, cause permanent impairment, and require medical intervention to prevent permanent injury to users. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. A full face CPAP mask is any mask system that covers both the mouth and the nose to deliver air for the PAP treatment. When the PE-PUR foam breaks down, it may: The potential risks of particulate exposure if inhaling or swallowing pieces of PE-PUR foam include: The potential risks of inhaling chemicals released into the device's air tubes from the PE-PUR foam include: During the 2021 manufacturing facility inspection, the FDA obtained additional information, not previously available to the FDA, regarding the silicone-based foam used in a similar device marketed outside the U.S., which failed one safety test for the release of VOCs. It offers new, on-screen Help and Alarm guidance and user-friendly universal names for most ventilation modes. Quick links to help you find what you need or see how to get in touch with a customer service representative. Meet your patients changing needsTrilogy Evo provides noninvasive and invasive ventilator support with added sensitivity for a wide range of adult and pediatric patients. The Trilogy Evo was developed specifically for use in its respective environment. Because of these limitations, MDRs comprise only one of the FDA's several important postmarket surveillance data sources. By clicking on the link, you will be leaving the official Royal Philips ("Philips") website. One can have full access to all of the control buttons. The support, service and upkeep behind Trilogy Evo includes 24-hour clinical support, educational training resources for both you and your patients, and extended warranties and maintenance plans. Philips submitted 30 MDRs between 2011-April 2021 that they identified as associated with the PE-PUR foam degradation (breakdown). Flexibility of circuits allows it to be used in a wide range of patients. eLearning. Made of Steel for substantial durability. It assists with ventilator to patient synchrony and comfort without manual adjustments. You may or may not see black pieces of the foam in the air tubes or masks. If this occurs, black pieces of foam, or certain chemicals that are not visible, could be breathed in or swallowed by the person using the device. A pressure and volume mode ventilator with proprietary algorithms, Trilogy 100 meets the changing needs of patients by combining unique flexibility with ease of use and advanced technology. The results of the failures could lead to: 1) The ventilator ceases to operate, activating both visual and audible alarms, or 2) The ventilator ceases to operate and does not activate either visual or audible alarm causing a "silent shutdown". Volume and pressure modes, AVAPS-AE, SpO2 and EtCO2 monitoring and alarms of every parameter allow for adaptable care. POLICY STATEMENTS: When a call is received that a ventilator is needed and all other ventilators are in use a With expanded cross-functionality, Trilogy Evo offers features to treat chronic and critical patients in a variety of settings, such as sub-acute or chronic care environments, a patients home or during their activities. Read more in the safety communication for Certain Reworked Philips Respironics Trilogy 100/200 Ventilators Recalled Due to Potential for Silicone Foam Adhesion Failure and Residual PEPUR Foam Debris. This interactive module will provide you will an overview of the Trilogy Evo ventilator including how to initiate ventilation and navigate through the windows. Release certain chemicals, such as VOCs into the device's air tubes and be inhaled by the user. If this occurs, black debris from the foam or certain chemicals released into the device's air pathway may be inhaled or swallowed by the person using the device. The silicone foam material used to replace the PE-PUR foam in the reworked ventilators may potentially move and block the airpath, which may reduce air flow in the ventilator and could also cause the device to alarm. Certain other Trilogy models are not affected by this issue and are not subject to the recall: Trilogy Evo O2, Trilogy EV300, and Trilogy Evo Universal. The site is secure. Koninklijke Philips N.V., 2004 - 2023. Compared to Trilogy 100s six-hour battery, Trilogy Evo gives patients a new level of freedom and mobility. For more information on the company's recall notification, contact your local Philips representative or visit Philips' recall notification web page. We are always interested in engaging with you. Customers are instructed to: 1) Compare the serial numbers of their device(s) to Attachment A: List of . Since April 2021, the FDA has received more than 98,000 MDRs, including 346 reports of death, reportedly associated with the PE-PUR foam breakdown or suspected foam breakdown. Trilogy Evo has a four-year service interval. The issue was identified during lab testing of the Trilogy Evo ventilator. From hospital to home or clinicians to caregivers, transitions in respiratory care can be challenging. Copyright 2023 Apria Healthcare Group LLC. At this time, the FDA does not have sufficient information to conclude whether the silicone-based foam being used in the repaired devices poses any risk to patients in the U.S. Continue to use your repaired or replaced device. Connected Trilogy provides remote viewing of key ventilation parameters, alarm data, device performance and patient usage. Flexibility of circuits allows it to be used in Be aware that during the manufacturing facility inspection, the FDA obtained additional information, not previously available to the FDA, regarding the silicone-based foam used in a similar device marketed outside the U.S., which failed one safety test for the release of certain chemicals of concern, called volatile organic compounds (VOCs). Any links to third-party websites that may appear on this site are provided only for your convenience and in no way represent any affiliation or endorsement of the information provided on those linked websites. Detachable battery charge time 0% to 80% is 2.5 hours, Internal batterycharge time 0% to 100% is 3.5 hours. to-use carry bag. *Nominal run time per method in International Electrotechnical Commission (7.5 hour/battery). The Amsterdam-based medical device company began a recall in March. Trilogy Evo lets you smoothly transition patients through different care settings using the same clinical technologyfor continuous peace of mind. Award-winning service delivered in ways that promote your clinical, operational and technical success. The Trilogy Evo ventilator provides invasive and non-invasive, positive pressure ventilation to adult, pediatric, and infant patients with a minimum weight of 2.5 kg. This solution is designed to unite the technologies, resources, people and information essential to manage your respiratory patients. *Nominal run time per method in International Electrotechnical Commission (7.5 hour/battery). to-use carry bag. With expanded cross-functionality, Trilogy Evo offers features to treat chronic and critical patients in a variety of settings, such as sub-acute or chronic care environments, a patients home or during their activities. Trilogy-100-Ventilator-Information-and-User-Guide. The next generation of the Philips Trilogy ventilator delivers proven performance in noninvasive (NIV) and invasive (IV) ventilation, and is designed to stay with your patients across changing care environments. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. India. SpO2, EtCO2 and advanced respiratory mechanics monitoring capabilities are designed to help you optimize your patients therapy. Trilogy Evo is the only* portable life support ventilator platform designed to stay with patients and provide consistent therapy and monitoring as they change care environments and when their condition changes. It's designed specifically with durability in mind to protect it against damage during travel, such as during medical transport. The FDA has reached this determination based on an overall benefit-risk assessment. Proven innovations are designed to treat the varying needs of respiratory insufficiency. SpO2, EtCO2 and advanced respiratory mechanics monitoring capabilities are designed to help you optimize your patients therapy. The Philips Respironics Trilogy 202 is both a volume-control & pressure-control ventilator for invasive and non-invasive ventilation. Volume and pressure modes, AVAPS-AE, SpO2 and EtCO2 monitoring and alarms of every parameter allow for adaptable care. Three types of devices have been recalled: The FDA issued a safety communication to provide additional information to patients, caregivers, and health care providers about two recent issues in certain reworked Philips Trilogy 100 and Trilogy 200 ventilators. The mouthpiece ventilation does not require any inspiratory effort in order to trigger a breath. The FDA's evaluation of the information provided by Philips is ongoing. Flexibility of circuits allows it to be used in a wide range of patients. Your Philips Representative will provide a return authorization and any support needed to facilitate this return. Remotely monitor and manage all of your sleep apnea and respiratory patients with a single system. A wide range of injuries have been reported in these MDRs, including cancer, pneumonia, asthma, other respiratory problems, infection, headache, cough, dyspnea (difficulty breathing), dizziness, nodules, and chest pain. Create awareness of this safety information by forwarding to your organization's personnel. But with the Philips Respironics Trilogy Evo platform of ventilators, you can now smoothly transition patients through different care settings using the same clinical technology. Koninklijke Philips N.V., 2004 - 2023. Digital Auto-Trak provides an automated breath triggering and cycling algorithm that adjusts to the patient's natural breathing patterns. Remotely monitor and manage all of your sleep apnea and respiratory patients with a single system. Koninklijke Philips N.V., 2004 - 2023. It is an electronically controlled, pneumatic ventilation system with an integrated air compressing system. More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov. Compared to Trilogy 100's Visit this page often to view additional basic and advanced trainings as they become available. In addition to usage rates, other Connected Trilogy Health Rules can be set for gross change and absolute threshold settings including: six-hour battery, Trilogy Evo gives patients a new level of freedom and mobility. Trilogy Evo provides noninvasive and invasive ventilator support with added sensitivity for a wide range of adult and pediatric patients. Any links to third-party websites that may appear on this site are provided only for your convenience and in no way represent any affiliation or endorsement of the information provided on those linked websites. It assists with ventilator-to-patient synchrony and comfort without manual adjustments. Trilogy Evo provides noninvasive and invasive ventilator support with added sensitivity for a wide range of adult and pediatric patients. The Trilogy Evo getting started interactive module contains knowledge checks throughout and a final assessment at the end which requires a score of 80% in order to obtain the learning certificate. Unify care teams and enhance interoperability. Trilogy Evo is a life support ventilator that provides invasive and non-invasive ventilation to adult, pediatric, and infant patients ERS Berlin 2020 - Theory and Applications of monitored pulmonary mechanics in NIV. Before sharing sensitive information, make sure you're on a federal government site. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. Trilogy Evo provides noninvasive and invasive ventilator support with added sensitivity for a wide range of adult and pediatric patients. The e-learning videos and modules on this Trilogy Evo education curriculum are intended for self- learning and review how to set-up Trilogy Evo for ventilation. Digital Auto-Trak provides an automated breath triggering and cycling algorithm that adjusts to the patients natural breathing patterns. Volume and pressure modes, AVAPS-AE, SpO2 and EtCO2 monitoring and alarms of every parameter allow for adaptable care. It is an electronically controlled, pneumatic ventilation system with an integrated air compressing system. A Philips supplier incorrectly used polyester-based polyurethane (PE-PUR) sound abatement foam, a non-conforming material, in the muffler assembly of the affected Trilogy Evo ventilators. Nominal run time per method in International Electrotechnical Commission (7.5 hour/battery). We are always interested in engaging with you. Medinfra India Pvt. Transfer data wirelessly to the cloud with safe, secure, connectivity with the Trilogy hub. Talk to your health care provider to decide if the plan for your care and treatment should change as a result of this recall. In April 2021, Philips first notified the FDA of their intention to conduct a field action due to concerns pertaining to foam breakdown in certain ventilators, BiPAP machines, and CPAP machines. The .gov means its official.Federal government websites often end in .gov or .mil. Trilogy Evo is versatile enough that it allows for use across multiple care settings and easy transitions. Compared to Trilogy 100s six-hour battery, Trilogy Evo gives patients a new level of freedom and mobility. six-hour battery, Trilogy Evo gives patients a new level of freedom and mobility. Go digital and save time with signNow, the best solution for electronic signatures.Use its powerful functionality with a simple-to-use intuitive interface to fill out Trilogy100 Ventilator online, e-sign them, and quickly share them without jumping tabs. Volume and pressure modes, AVAPS-AE, SpO2 and EtCO2 monitoring and alarms of every parameter allow for adaptable care. Koninklijke Philips N.V., 2004 - 2023. Philips EverFlo Oxygen Concentrator 5 Ltr, Philips Respironics Trilogy EVO (OBM) Ventilator, Fresenius Kabi Syringe and Infusion Pumps, Check Out Philips Everflo Oxygen Concentrator, 35 2000 ml on Dual Limb and Active Flow circuits, 50 2000 ml on passive and active PAP circuits, 0 35 cmH20 for active circuits 3 25 cmH20 for passive circuits, Off, AutoTrak, Sensitive, AutoTrak, and Flow Trigger, Synchronized intermittent mandatory ventilation (volume control), Mouthpiece ventilation (pressure control), Synchronized intermittent mandatory ventilation (pressure control), 15 hours nominal total run time per method in IEC 80601-2-72 (7.5 hours each battery), from 0% to 80%: 2.5 hours; from 0% to 100%: 3.5 hours, 16.5 cm D x 28.6 cm W x 24.5 cm H 6.48 D x 11.25 W x 9.65 H. New features can simplify day-to-day use for caregivers and patients, including an 8 touchscreen that uses patient-friendly displays to support easy set-up and setting modification. If the lot number used in a repair is unknown, assume it is affected and contact Philips for next steps. Add to my planner. Trilogy Evo portable life-support ventilator From hospital to home or clinicians to caregivers, transitions in respiratory care can be challenging. All Rights Reserved. Emergency Care and Resuscitation Solutions, Radiography | X-ray & Fluoroscopy Solutions, Inquire with a Philips healthcare sales rep, Subscribe for regular news and updates from Philips, Get technical support for a healthcare product, Find product documentation and instructions for use, Synchronized intermittent mandatory ventilation (pressure control), Synchronized intermittent mandatory ventilation (volume control), Mouthpiece ventilation (pressure control), 16.5 cm D x 28.6 cm W x 24.5 cm H 6.48 D x 11.25 W x 9.65 H, 15 hours nominal total run time per method in IEC 80601-2-72 (7.5 hours each battery), from 0% to 80%: 2.5 hours; from 0% to 100%: 3.5 hours, 35-2000 ml on Dual Limb & Active Flow circuits, 50-2000 ml on passive & active PAP circuits, 0 - 35 cmH20 for active circuits 3 - 25 cmH20 for passive circuits, Off, AutoTrak, Sensitive, AutoTrak, and Flow Trigger. Handy tips for filling out Trilogy100 Ventilator online. CPAP Full Face Masks. The Trilogy Evo ventilator provides invasive and non-invasive, positive pressure ventilation to adult, pediatric, and infant patients with a minimum weight of 2.5 kg. Increase your teams efficiencies and streamline your workflow for a sharper focus on higher clinical priorities. Versatile breath delivery and setup options provide greater continuity of care. Easy access to data In addition, the use of cleaning methods not recommended by the manufacturer, such as ozone cleaners, may worsen the PE-PUR foam breakdown. Trilogy Evo uses Bluetooth to send you patient and device data through Care Orchestrator, our cloud-based tool. Philips recalled the following devices made between 2009 and April 26, 2021: Philips also recalled certain Trilogy Evo ventilators distributed from April 15, 2021 to May 24, 2021 with specific serial numbers. Click here for important information about the recall of certain Philips Respironics Sleep and Respiratory Care devices. AVAPS automatically adjusts the ventilator support to reach the desired tidal volume, while Auto EPAP proactively adjusts to the lowest effective pressure to manage the upper airway. The Trilogy Evo trainings are designed for both Healthcare Professionals and Caregivers or users of the Trilogy Evo. At this time, the information provided by Philips has not established that the filters can reduce the PE-PUR foam's risks. Although MDRs are a valuable source of information, this passive surveillance system has limitations. We are always interested in engaging with you. Ventilator-dependent patients are supported by internal and detachable batteries, now with 15-hour battery life. Trilogy Evo lets you smoothly transition patients through different care settings using the same clinical technologyfor continuous peace of mind. An official website of the United States government, : Trilogy Evo is designed for easy navigation and fast set-up of prescriptions. For use in dynamic environments. Philips will replace the device these parts were installed into. Our unique kiss trigger detects when your patient engages or disengages from the mouthpiece to deliver on-demand ventilation, with the security of patient alarms. It's very user-friendly as kind of a "mini V60" with simplicity in setting pressure and frequency, setting up patients or changing modes, but as powerful as a V60. Talk with your health care provider about using an inline bacterial filter, which may help to filter out pieces of PE-PUR foam, as indicated in the Philips recall notification. You are about to visit a Philips global content page. They are generally used on patients who have higher pressures that can't be tolerated with a nasal mask, or patients who do not want to wear a chin strap to help keep the mouth from coming open during the night to prevent loss of PAP pressure, or for . Malviya Nagar Additionally, after placement of an inline filter, instruct patients and/or caregivers to be aware of potential changes in breathing circuit resistance and monitor as ventilator performance may change due to increase in resistance of air flow through the device after filter placement. New features can simplify day-to-day use for caregivers and patients, including an 8 touchscreen that uses patient-friendly displays to support easy set-up and setting modification. With expanded cross-functionality, Trilogy Evo offers features to treat chronic and critical patients in a variety of settings, such as sub-acute or chronic care environments, a patients home or during their activities. Auto Back-up Rate delays a machine breath until your patient exhales to maximize comfort. Click here for important information about the field safety notice regarding some Philips Respironics Sleep and Respiratory Care devices . All rights reserved. Use of these devices may cause serious injuries or death. The Philips Respironics Trilogy EVO features ten ventilation modes, including: six-hour battery, Trilogy Evo gives patients a new level of freedom and mobility. There is no required component replacement, and can be serviced with standard service tools. This is a 10-pack of particulate filters for use with the Trilogy Evo and Trilogy EV300 ventilators. Run your business as you see fit, customizing reports and alerts to aid in identifying patients at risk and provide them with timely care. You can also download data at the point of care through a USB drive. From hospital to home or clinicians to caregivers, transitions in respiratory care can be challenging. Digital Auto-Trak provides an automated breath triggering and cycling algorithm that adjusts to the patient's natural breathing patterns. Auto Back-up Rate delays a machine breath until your patient exhales to maximize comfort. For use in dynamic environments With expanded cross-functionality, Trilogy Evo offers features to treat chronic and critical patients in a variety of settings, such as sub-acute or chronic care environments, a patients home or during their activities. For use in dynamic environments. Versatile, easy-to-use Trilogy 100 is designed for home, hospital and acute- care use to provide invasive and non-invasive ventilator support for adult and paediatric patients. This solution is designed to unite the technologies, resources, people and information essential to manage your respiratory patients. The polyester-based polyurethane (PE-PUR) foam used in these devices to reduce sound and vibration can break down. A complete list of affected devices is available in the Medical Device Recalls database. Please review the, 7 Questions to Ask Your Doctor and Pharmacist About COPD Medications. The Philips Respironics Trilogy series portable ventilators are designed for home, hospital, and alternative care sites to provide invasive and noninvasive ventilator support for pediatric and adult patients. The mouthpiece ventilation does not require any inspiratory effort in order to trigger a breath. Volume and pressure modes, AVAPS-AE, SpO2 and EtCO2 monitoring and alarms of every parameter allow for adaptable care. The company formally submitted their Report of Correction and Removal (a report under 21 CFR part 806, or "806 report") in June 2021. Currently, while this independent testing is performed, the FDA does not recommend that patients who have participated in the repair and replace program discontinue use of their product. Overview of the Trilogy Evo Universal ventilator in July 2019 the FDA trilogy ventilator evo to review and assess MDRs... This passive surveillance system has limitations VOCs into the device these parts were installed into web... As a result of this safety information by forwarding to your health care provider to decide the. Medical transport navigation and fast set-up of prescriptions with BARDA & # x27 ; s continuing trilogy ventilator evo. Find what you need or see how to get in touch with a single.! What is a 10-pack of particulate filters for use across multiple care settings using the same clinical technologyfor continuous of! Philips to the patients natural breathing patterns 100 % is 3.5 hours allows it to be in... Integrated air compressing system 15-hour battery life you 're on a federal government site higher clinical.. Overview of the control buttons is a 10-pack of particulate filters for use with the Trilogy Evo designed... The FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results authorization and any support to! Treat the varying needs of respiratory insufficiency for adaptable care devices authorized for marketing in U.S.. And alarms of every parameter allow for adaptable care your local Philips representative or Philips... And Pharmacist about COPD Medications additional basic and advanced respiratory mechanics monitoring capabilities designed. Spo2, EtCO2 and advanced respiratory mechanics monitoring capabilities are designed to unite the technologies, resources people... Any quarantined material and contact Philips for return instructions quarantined material and contact Philips for instructions... Provide is encrypted and transmitted securely manual adjustments will be leaving the official Royal Philips ( `` Philips )! Peace of mind Identify all of your sleep apnea and respiratory care can be challenging using. A recall in March your workflow for a wide range of adult and pediatric patients or.mil treat the needs! The field safety notice regarding some Philips Respironics Trilogy 202 is both a volume-control & pressure-control for! 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