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. Remotely monitor and manage all of your sleep apnea and respiratory patients with a single system. Volume and pressure modes, AVAPS-AE, SpO2 and EtCO2 monitoring and alarms of every parameter allow for adaptable care. Ventilator-dependent patients are supported by internal and detachable batteries, now with 15-hour battery life. Through its 15-hour battery life, it provides you the next level of mobility so you can achieve a higher quality of life during treatment. Create awareness of this safety information by forwarding to your organization's personnel. Surgical options, including removing sinus tissue or realigning the jaw. Trilogy Evo provides noninvasive and invasive ventilator support with added sensitivity for a wide range of adult and pediatric patients. UPDATE - April 13, 2023: To provide transparency for consumers who are awaiting a replacement device, the FDA is clarifying that the number of replacement and remediated devices that have been shipped to consumers in the U.S. is considerably less than the 2,460,000 number of "new replacement devices and repair kits" posted on Philips' website. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Detachable battery charge time 0% to 80% is 2.5 hours, internal battery charge time 0% to 100% is 3.5 hours. A/C-VC modeActivePAPcircuit, PEEP 3cmH2O andVt800ml.. 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. This solution is designed to unite the technologies, resources, people and information essential to manage your respiratory patients. UPDATE - On April 7, 2023: The FDA classified Certain Reworked DreamStation CPAP, BiPAP Machines for the Risk They May Deliver Inaccurate or Insufficient Therapy as a Class I recall, the most serious type of recall. Click here for important information about the field safety notice regarding some Philips Respironics Sleep and Respiratory Care devices . It offers new, on-screen Help and Alarm guidance and user-friendly universal names for most ventilation modes. Versatile breath delivery and setup options provide greater continuity of care. Trilogy 200 helps care teams provide quality respiratory care while meeting patients evolving needs. Digital Auto-Trak provides an automated breath triggering and cycling algorithm that adjusts to the patient's natural breathing patterns. It assists with ventilator to patient synchrony and comfort without manual adjustments. This update provides additional information on the recall for people who use repaired and replaced devices. data fl ow, Trilogy Evo helps benefi t a broad spectrum of patients, from newborns to adults. A complete list of affected devices is available in the Medical Device Recalls database. In addition to usage rates, other Connected Trilogy Health Rules can be set for gross change and absolute threshold settings including: Nominal run time per method in International Electrotechnical Commission (7.5 hour/battery). 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. Innovative financing solutions tailored for healthcare, providing both industry expertise and a reliable source of funds. Auto Back-up Rate delays a machine breath until your patient exhales to maximize comfort. 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. 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. Its designed specifically with durability in mind to protect it against damage during travel, such as during medical transport. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Proven innovations are designed to treat the varying needs of respiratory insufficiency. Increase your teams efficiencies and streamline your workflow for a sharper focus on higher clinical priorities. Trilogy Evo is versatile enough that it allows for use across multiple care settings and easy transitions. Ltd. Please navigate to the training sections most relevant to you. The Philips Respironics Trilogy EVO features ten ventilation modes, including: 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 pediatric patients. SpO2, EtCO2 and advanced respiratory mechanics monitoring capabilities are designed to help you optimize your patients therapy. Instructions include video demonstrations and user manuals for respiratory therapy Read more For privacy reasons YouTube needs your permission to be loaded. Request a demo Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. Volume and pressure modes, AVAPS-AE, SpO2 and EtCO2 monitoring and alarms of every parameter allow for adaptable care. Trilogy Evo uses Bluetooth to send you patient and device data through Care Orchestrator, our cloud-based tool. By clicking on the link, you will be leaving the official Royal Philips ("Philips") website. 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. Disclaimers 1. Connected Trilogy Health Rules can be customized with patient-specific ventilator parameters to trigger notifications that proactively identify patients with potential increased need for intervention. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 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. Trilogy Evo portable life-support ventilator From hospital to home or clinicians to caregivers, transitions in respiratory care can be challenging. Koninklijke Philips N.V., 2004 - 2023. This solution is designed to unite the technologies, resources, people and information essential to manage your respiratory patients. Do not stop or change patient therapy unless the patient has consulted their health care provider or unless a replacement Trilogy Evo ventilator has been provided. The Trilogy Evo ventilators with non-conforming foam were distributed to customers in the United States and Korea. Ventilator-dependent patients are supported by internal and detachable batteries, now with 15-hour battery life. 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. Flexibility of circuits allows it to be used in a wide range of patients. All Rights Reserved. This URGENT Field Safety Notice is intended to inform you of the problem. Features. Trilogy Evo is the only industry-leading ventilator with 15 hours of battery life with an internal and detachable battery. 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. Release certain chemicals, such as VOCs into the device's air tubes and be inhaled by the user. CPAP Full Face Masks. 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. The MDRs received included both mandatory reports from Philips and voluntary reports from health professionals, consumers, and patients. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. The mouthpiece ventilation does not require any inspiratory effort in order to trigger a breath. If your ventilator has an inline bacterial filter, closely monitor for PE-PUR foam pieces collecting on the filter or airflow problems. Trilogy Evo needs preventive maintenance only every four years, and minimal equipment for calibration. Enquire 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 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. Detachable battery charge time 0% to 80% is 2.5 hours, internal battery charge time 0% to 100% is 3.5 hours. 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. Before sharing sensitive information, make sure you're on a federal government site. One can have full access to all of the control buttons. 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). Shop for products on our online store of order seamlessly through your own procurement system. The FDA has identified this as a Class I recall, the most serious type of recall. It may be used for both invasive and non-invasive ventilation. 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. Its ready to be mounted onto a roll-stand or a wheelchair, with a mountable, easy- to-use carry bag. The Philips Respironics Trilogy 202 is both a volume-control & pressure-control ventilator for invasive and non-invasive ventilation. A replacement Trilogy Evo ventilator will be provided by Philips. The Trilogy Evo getting started interactive module contains knowledge checks throughout and a final assessment at the end which. 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. SpO2, EtCO2 and advanced respiratory mechanics monitoring capabilities are designed to help you optimize your patients therapy. An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, UPDATE: Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication, Recalled BiPAP or CPAP Machines & Recommendations, Repaired and Replaced BiPAP or CPAP Machines & Recommendations, Potential Health Risks from the PE-PUR Foam, FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls, Certain Reworked Philips Respironics Trilogy 100/200 Ventilators Recalled Due to Potential for Silicone Foam Adhesion Failure and Residual PEPUR Foam Debris, Register your device(s) on Philips' recall website, report the issue or problem through the MedWatch Voluntary Reporting Form, problem through the MedWatch Voluntary Reporting Form, potential risks associated with the use of ozone and ultraviolet (UV) light products for cleaning CPAP machines and accessories, report the problem through the MedWatch Voluntary Reporting Form, FDA's user facility reporting requirements, Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls, Garbin Plus, Aeris, LifeVent (ventilator). We are concerned this may impact the estimated wait time for consumers still awaiting a replacement device. The polyester-based polyurethane (PE-PUR) sound abatement foam, which is used to reduce sound and vibration in these affected devices, may break down and potentially enter the device's air pathway. Trilogy Evo lets you smoothly transition patients through different care settings using the same clinical technologyfor continuous peace of mind. All rights reserved. The FDA posted answers to frequently asked questions about this recall: FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls. 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. Determine if any Trilogy Evo devices have been repaired using Trilogy Evo Muffler Assembly Part Number 1135357 starting 14 April 2021 or later. 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. Volume and pressure modes, AVAPS-AE, SpO2 and EtCO2 monitoring and alarms of every parameter allow for adaptable care. Remotely monitor and manage all of your sleep apnea and respiratory patients with a single system. If the lot number used in repair is between 210414 and 210524. 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. Contact us Specifications Contact us Request contact Specifications Can we help? Click here for important information about the recall of certain Philips Respironics Sleep and Respiratory Care devices. You may or may not see black pieces of the foam in the air tubes or masks. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. It is an electronically controlled, pneumatic ventilation system with an integrated air compressing system. This solution is designed to unite the technologies, resources, people and information essential to manage your respiratory patients. All rights reserved. Trilogy Evo is designed for easy navigation and fast set-up of prescriptions. Volume and pressure modes, AVAPS-AE, SpO2 and EtCO2 monitoring and alarms of every parameter allow for adaptable care. If the lot number used in a repair is unknown, assume it is affected and contact Philips for next steps. Ventilator-dependent patients are supported by internal and detachable batteries, now with 15-hour battery life. The newest Trilogy device was made to be user-friendly without compromising the advanced features of the innovative Trilogy family technology. Trilogy Evo needs preventive maintenance only every four years, and minimal equipment for calibration. The .gov means its official.Federal government websites often end in .gov or .mil. You can also download data at the point of care through a USB drive. By clicking on the link, you will be leaving the official Royal Philips ("Philips") website. You can also download data at the point of care through a USB drive. Portable Oxygen Concentrators and Accessories, Sleep Diagnostics Systems Accessories and Supplies, Trilogy Evo is the only industry-leading ventilator with 15 hours of battery life with an internal and detachable battery, Every Trilogy Evo is equipped to connect with Care Orchestrator, and you can download data wirelessly or via the USB port, Trilogy Evo has a four-year service interval. Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities. Trilogy Evo is designed for easy navigation and fast set-up of prescriptions. Compared to Trilogy 100's six-hour battery, Trilogy Evo gives patients a new level of freedom and mobility. Eight of those reports were from the U.S. The Philips Respironics Trilogy 202 is both a volume-control & pressure-control ventilator for invasive and noninvasive ventilation. Nominal run time per method in InternationalElectrotechnicalCommission (7.5 hr/battery). Digital Auto-Trak provides an automated breath triggering and cycling algorithm that adjusts to the patient's natural breathing patterns. 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. With Care Orchestrator, you have the power to create custom health rules based on your best practices and proven processes. 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. Use of these devices may cause serious injuries or death. to-use carry bag. 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. It assists with ventilator to patient synchrony and comfort without manual adjustments. The Trilogy Evo is a portable hospital-to-home ventilator that is intuitive, easy to use, features a long-lasting battery and more! Easy access to data This Trilogy Ventilator Carrier measures 12 Wide x 13 Long x 8 High. Versus Trilogy 100 and 200, 1. *Nominal run time per method in International Electrotechnical Commission (7.5 hour/battery). The FDA has requested that Philips retain an independent laboratory to perform additional testing to determine what, if any, potential safety risks may be posed to patients by the silicone-based foam. We are always interested in engaging with you. We encourage consumers to contact Philips to get an update on the status of their replacement device. 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. a wide range of patients. 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 InternationalElectrotechnicalCommission (7.5 hr/battery). The devices are used to help breathing. It offers new, on-screen Help and Alarm guidance and user-friendly universal names for most ventilation modes. A/C-VC modeActivePAPcircuit, PEEP 3cmH2O andVt800ml. 2. * Note: Trilogy 100 and 200 ventilators were previously recalled in June 2021 due to the same foam risk. Inline bacterial filters may increase the resistance to air flow through the device, which could mean the ventilator will not ventilate adequately. All Rights Reserved. Trilogy Evo ventilators deliver enhanced performance in both non-invasive (NIV) and invasive ventilation. You are about to visit a Philips global content page. The incidence, prevalence, or cause of an event cannot typically be determined from this reporting system alone due to under-reporting of events, inaccuracies in reports, lack of verification that the device caused the reported event, and lack of information about details such as frequency of device use. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. At this time, the FDA has determined that discontinuing use of one of these devices may be more harmful to a patient's health and quality of life. It's designed specifically with durability in mind to protect it against damage during travel, such as during medical transport. 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 . The results from the independent testing are needed to determine if the silicone-based foam used in the repaired devices does in fact present any risks to patients, and the FDA will communicate those results to the public as soon as they are available. This module will provide you with some basics on how to use your Trilogy Evo ventilator. Do not stop or change ventilator use until you have talked to your health care provider. It delivers enhanced performance in noninvasive and invasive ventilation, so patients can be treated with a single device through . Turn the Trilogy nebulizer feature to "on" 3. The packing instructions are in Appendix A of the notification. Trilogy Evo provides noninvasive and invasive ventilator support with added sensitivity for a wide range of adult and pediatric patients. 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. Trilogy Evo: Our new, portable life-support ventilator platform designed to: Deliver maximum portability to patients with 15 hours of battery life, easily mounting on wheelchairs, and a convenient carrying bag that lets you see the screen and alarms, Connect to CareOrchestrator enabling you to track and assess patientsventilation data fromvirtually anywhere, Provide a longerlifespan (10 years). 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. For more information on the company's recall notification, contact your local Philips representative or visit Philips' recall notification web page. Flexibility of circuits allows it to be used in a wide range of patients. Segregate inventory of Repair Kit - Trilogy Evo Muffler Assembly Part Number 1135257, and quarantine any lot between 210414 and 210524. "Connect with Philips Online: - Visit Philips Sleep and Respiratory Care Website: www.philips.com/healthcare/solutions/sleep-and-respiratory-care- Find Phili. With Care Orchestrator, you have the power to create custom health rules based on your best practices and proven processes. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. 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. The 2,460,000 number includes manufactured repair kits that Philips shipped internally to their repair facilities, which are not replacement or remediated devices that have been shipped to consumers. Trilogy-100-Ventilator-Information-and-User-Guide. Patients who have additional concerns should talk to their health care provider about the plan for their care and treatment. The polyester-based polyurethane (PE-PUR) foam used in these devices to reduce sound and vibration can break down. Versatile breath delivery and setup options provide greater continuity of care. Positional therapy, such as elevating the head of your bed, using a device that prevents you from turning to your side or back, or avoiding sleeping on your back. Made of Steel for substantial durability. Trilogy Evo needs preventive maintenance only every four years, and minimal equipment for calibration. 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. Be loaded the foam in the medical device Recalls database to send you and. Visit a Philips global content page inline bacterial filter, closely monitor for foam! 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