You are about to visit a Philips global content page. The Trilogy EVO Ventilator is a cross-functional machine designed specifically for use in multiple environments, including travel. Trilogy-100-Ventilator-Information-and-User-Guide. Easy access to data For more information on the company's recall notification, contact your local Philips representative or visit Philips' recall notification web page. The FDA continues to review and assess the MDRs and will keep the public informed as new information becomes available. 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. The devices are used to help breathing. Trilogy Evo uses Bluetooth to send you patient and device data through Care Orchestrator, our cloud-based tool. If you have additional concerns, talk to your health care provider about the plan for your care and treatment. Trilogy Evo is designed for easy navigation and fast set-up of prescriptions. 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. 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. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. 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. You can also download data at the point of care through a USB drive. Flexibility of circuits allows it to be used in a wide range of patients. Made of Steel for substantial durability. All rights reserved. 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. Assure blankets are not covering the exhalation port/valve F:\Company Shared Folders\Respiratory\New Set Ups\Trilogy ventilator set up\forms\MASTER TEMPLATES\Miscellaneous\Trilogy Alarm Troubleshooting Guide 6-2019 Trilogy Evo portable life-support ventilator From hospital to home or clinicians to caregivers, transitions in respiratory care can be challenging. *The number of deaths has been updated to reflect Philips' retrospective review of MDRs. Mask (select one) Full Face Mask Nasal Mask Nasal Pillows RT to Fit Patient For Mask The newest Trilogy device was made to be user-friendly without compromising the advanced features of the innovative Trilogy family technology. For use in dynamic environments. Philips will replace the device these parts were installed into. Flexibility of circuits allows it to be used in a wide range of patients. Detachable battery charge time 0% to 80% is 2.5 hours, internal battery charge time 0% to 100% is 3.5 hours. With Care Orchestrator, you have the power to create custom health rules based on your best practices and proven processes. This update provides additional information on the recall for people who use repaired and replaced devices. 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. Versatile, easy-to-use Trilogy 200 provides invasive and non-invasive ventilator support for adult and pediatric patients in the home, hospital and acute-care sites. The Trilogy Evo ventilators with non-conforming foam were distributed to customers in the United States and Korea. 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. Strategic Partnerships and Healthcare Solutions. 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. It's ready to be mounted onto a roll-stand or a wheelchair, with a mountable, easy- Flexibility of circuits allows it to be used in a wide range of patients. to-use carry bag. Please review the, 7 Questions to Ask Your Doctor and Pharmacist About COPD Medications. 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. Compared to Trilogy 100's Versatile breath delivery and setup options provide greater continuity of care. Compared to Trilogy 100's six-hour battery, Trilogy Evo gives patients a new level of freedom and mobility. Versatile breath delivery and setup options provide greater continuity of care. 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. Use another similar device that is not a part of this recall. 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. Ventilator-dependent patients are supported by internal and detachable batteries, now with 15-hour battery life. You may or may not see black pieces of the foam in the air tubes or masks. 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. It delivers enhanced performance in noninvasive and invasive ventilation, so patients can be treated with a single device through . Remotely monitor and manage all of your sleep apnea and respiratory patients with a single system. 110017, New Delhi Compared to Trilogy 100's The Philips Respironics Trilogy 202 is both a volume-control & pressure-control ventilator for invasive and non-invasive ventilation. 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. With Care Orchestrator, you have the power to create custom health rules based on your best practices and proven processes. With BARDA's continuing support, Philips finally won FDA approval for the Trilogy Evo Universal ventilator in July 2019. Enable consistent and high-quality invasive and noninvasive ventilation . You are about to visit a Philips global content page. Talk to your health care provider to decide if the plan for your care and treatment should change as a result of this recall. Proven PerformancePhilips Respironics Trilogy EVO (OBM) Portable Ventilator. Philips Respironics sent an Urgent Medical Device Recall notification to Trilogy Evo ventilator customers on December 21, 2021, and the company sent an updated version to clarify information on cleaning and filters on January 13, 2022. Contact us Specifications Contact us Request contact Specifications Can we help? Easier serviceability and less costover time, Online ordering for healthcare professionals, labs and DMEs, Making your job easy and adding efficiencies to your business, When youre in a hurry, speed through to checkout with Quick Order our fastest way to resupply, In addition to searching both your online and offline orders, you can track order status in real time with shipping confirmations, Quick and easy returns and repair requests now online, Save time by submitting your requests online without having to call customer service, See the five ways Trilogy Evo helps you support seamless care, Transition to the future with Philips Respironics Trilogy Evo. It assists with ventilator-to-patient synchrony and comfort without manual adjustments. By clicking on the link, you will be leaving the official Royal Philips ("Philips") website. Add to my planner. Proven innovations are designed to treat the varying needs of respiratory insufficiency. Trilogy-Clinical-Manual. It's designed specifically with durability in mind to protect it against damage during travel, such as during medical transport. Please note, these devices can continue to be safely Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX. By clicking on the link, you will be leaving the official Royal Philips ("Philips") website. - Used this ventilator: Trilogy EVO The Ventilator can be removed from the Carrier while the main air tubing is still connected. Detachable battery charge time 0% to 80% is 2.5 hours, Internal batterycharge time 0% to 100% is 3.5 hours. Before sharing sensitive information, make sure you're on a federal government site. 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 makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Inline bacterial filters may increase the resistance to air flow through the device, which could mean the ventilator will not ventilate adequately. Every Trilogy Evo is equipped to connect with Care Orchestrator, and you can download data wirelessly or via the USB port. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. 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. 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. Klink, the Philips spokesman, said the $13.8 million from HHS covered. The FDA has reached this determination based on an overall benefit-risk assessment. Connected Trilogy provides remote viewing of key ventilation parameters, alarm data, device performance and patient usage. Trilogy Evo provides noninvasive and invasive ventilator support with added sensitivity for a wide range of adult and pediatric patients. 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. 4. It assists with ventilator to patient synchrony and comfort without manual adjustments. It assists with ventilator to patient synchrony and comfort without manual adjustments. CPAP Full Face Masks. 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 patient's home or during their activities. SpO2, EtCO2 and advanced respiratory mechanics monitoring capabilities are designed to help you optimize your patients therapy. 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 issue was identified during lab testing of the Trilogy Evo ventilator. 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. 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. 80/16A, Ground Floor Trilogy Evo is a next-generation portable home ventilator that provides invasive and noninvasive positive pressure ventilation for the care of patients weighing 2.5 kg, and it is intended for use by qualified, trained personnel under the direction of a physician. 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. The Food and Drug Administration posted the recall to its database on Monday, designating it a Class I recall, the most . From hospital to home or clinicians to caregivers, transitions in respiratory care can be challenging. 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. This interactive module will provide you will an overview of the Trilogy Evo ventilator including how to initiate ventilation and navigate through the windows. 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 ventilator provides continuous or intermittent positive pressure ventilation for the care of pediatric through adult patients weighing at least 2.5 kg who require mechanical. The site is secure. Malviya Nagar This Trilogy Ventilator Carrier measures 12 Wide x 13 Long x 8 High. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Digital Auto-Trak provides an automated breath triggering and cycling algorithm that adjusts to the patients natural breathing patterns. Do not stop or change ventilator use until you have talked to your health care provider. The newest Trilogy device was made to be user-friendly without compromising the advanced features of the innovative Trilogy family technology. This solution is designed to unite the technologies, resources, people and information essential to manage your respiratory patients. The MDRs received included both mandatory reports from Philips and voluntary reports from health professionals, consumers, and patients. Disclaimers 1. Trilogy Evo Trilogy Evo O2 Trilogy 100 Trilogy 200 Philips Hospital/Home Ventilation Solutions 1. 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. Easy access to data *Nominal run time per method in International Electrotechnical Commission (7.5 hour/battery). 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. The PE-PUR foam issue may result from exposure to hot and humid conditions and may be exacerbated by the use of ozone cleaners or other cleaning methods not recommended by the manufacturer. Instructions include video demonstrations and user manuals for respiratory therapy Read more For privacy reasons YouTube needs your permission to be loaded. The pressure- and volume-mode ventilator has proprietary therapy algorithms, connectivity and enhanced triggering sensitivity which decreases the work of breathing. Ventilator-dependent patients are supported by internal and detachable batteries, now with 15-hour battery life. 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. Its designed specifically with durability in mind to protect it against damage during travel, such as during medical transport. 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. It is an electronically controlled, pneumatic ventilation system with an integrated air compressing system. 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. 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. Detachable battery charge time 0% to 80% is 2.5 hours, internal battery charge time 0% to 100% is 3.5 hours. 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. Nominal run time per method in InternationalElectrotechnicalCommission (7.5 hr/battery). 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 FDA's evaluation of the information provided by Philips is ongoing. Compared to Trilogy 100s six-hour battery, Trilogy Evo gives patients a new level of freedom and mobility. The Philips Trilogy Evo is only portable life-support ventilator platform designed to stay with patients and provide consistent therapy and monitoring as the. The Trilogy Evo was developed specifically for use in its respective environment. 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. The FDA's in-depth review and analysis of these new MDRs will include examining the possible reasons for the increased number of reports. It's ready to be mounted onto a roll-stand or a wheelchair, with a mountable, easy- Surgical options, including removing sinus tissue or realigning the jaw. It assists with ventilator to patient synchrony and comfort without manual adjustments. 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. The mouthpiece ventilation does not require any inspiratory effort in order to trigger a breath. Request a demo Click here for important information about the recall of certain Philips Respironics Sleep and Respiratory Care devices. 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