a wide range of patients. 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. Detachable battery charge time 0% to 80% is 2.5 hours, Internal batterycharge time 0% to 100% is 3.5 hours. Volume and pressure modes, AVAPS-AE, SpO2 and EtCO2 monitoring and alarms of every parameter allow for adaptable care. *Nominal run time per method in International Electrotechnical Commission (7.5 hour/battery). 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. Create awareness of this safety information by forwarding to your organization's personnel. Innovative financing solutions tailored for healthcare, providing both industry expertise and a reliable source of funds. 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. Customers are instructed to: 1) Compare the serial numbers of their device(s) to Attachment A: List of . Add to my planner. These reports, along with data from other sources, can contribute important information to a medical device's benefit-risk assessment. A full face CPAP mask is any mask system that covers both the mouth and the nose to deliver air for the PAP treatment. Trilogy Evo uses Bluetooth to send you patient and device data through Care Orchestrator, our cloud-based tool. These issues could potentially result in serious injury and require medical intervention to prevent permanent injury. Its designed specifically with durability in mind to protect it against damage during travel, such as during medical transport. Volume and pressure modes, AVAPS-AE, SpO2 and EtCO2 monitoring and alarms of every parameter allow for adaptable care. From hospital to home or clinicians to caregivers, transitions in respiratory care can be challenging. Request a demo The filters protect patients from impurities in the air, the ventilator from corrosion, and healthcare professionals from exhaled pathogens and medication remnants. Trilogy Evo portable life-support ventilator From hospital to home or clinicians to caregivers, transitions in respiratory care can be challenging. 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. Philips issued a recall of its Trilogy Evo portable electric ventilators due to a problem with an internal sensor that can lead to under-delivery of oxygen. 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. You can also download data at the point of care through a USB drive. Trilogy Evo needs preventive maintenance only every four years, and minimal equipment for calibration. 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. 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. Printing and scanning is no longer the best way to manage documents. 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 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. See the latest FDA Actions in the FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls. The Trilogy Evo is a portable hospital-to-home ventilator that is intuitive, easy to use, features a long-lasting battery and more! This solution is designed to unite the technologies, resources, people and information essential to manage your respiratory patients. 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. 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 newest Trilogy device was made to be user-friendly without compromising the advanced features of the innovative Trilogy family technology. 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. 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. Emergency Care and Resuscitation Solutions, Radiography | X-ray & Fluoroscopy Solutions, Transition to the future of respiratory care with, For more information on our Philips Learning connection please click here. six-hour battery, Trilogy Evo gives patients a new level of freedom and mobility. 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 site is secure. 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. The Trilogy Evo trainings are designed for both Healthcare Professionals and Caregivers or users of the Trilogy Evo. 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. 4. Volume and pressure modes, AVAPS-AE, SpO2 and EtCO2 monitoring and alarms of every parameter allow for adaptable care. a wide range of patients. The ventilator can measure, display, record, and alarm oxygen saturation level (SpO2), fraction of inspired oxygen (FiO2), carbon dioxide (CO2) and pulse rate data when integrated with the appropriate accessories. What is the Trilogy Evo Ventilator? 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. 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. Turn the Trilogy nebulizer feature to "on" 3. Contact Philips for next steps. The devices are used to help breathing. to-use carry bag. * Note: Trilogy 100 and 200 ventilators were previously recalled in June 2021 due to the same foam risk. Run your business as you see fit, customizing reports and alerts to aid in identifying patients at risk and provide them with timely care. An official website of the United States government, : All rights reserved. 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. Ventilator-dependent patients are supported by internal and detachable batteries, now with 15-hour battery life. Bacterial filters will not help to reduce exposure to certain chemicals that may be released from the PE-PUR foam. A/C-VC modeActivePAPcircuit, PEEP 3cmH2O andVt800ml. 2. Trilogy Evo is designed for easy navigation and fast set-up of prescriptions. Easy access to data By specifying your reason for contact we will be able to provide you with a better service. With Care Orchestrator, you have the power to create custom health rules based on your best practices and proven processes. The mouthpiece ventilation does not require any inspiratory effort in order to trigger a breath. The U.S. Food and Drug Administration (FDA) is updating the June 2021 safety communication about the Philips Respironics (Philips) recalled ventilators, bilevel positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines, and continuous positive airway pressure (CPAP) machines. 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. Its ready to be mounted onto a roll-stand or a wheelchair, with a mountable, easy- to-use carry bag. Unify care teams and enhance interoperability. Instruct patients and/or caregivers to closely monitor the bacteria filter for foam debris. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Change filter (may be blocked with powder, smoke, dust, etc.) 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. Ventilator-dependent patients are supported by internal and detachable batteries, now with 15-hour battery life. 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 process for initiation and ongoing evaluation of the effectiveness of mechanical ventilation using a Trilogy Evo via an artificial airway in the inpatient setting. Using an inline bacterial filter may help to filter out particles of foam. Click here for important information about the recall of certain Philips Respironics Sleep and Respiratory Care devices. Trilogy Evo, Material Numbers DS2110X11B (USA) and KR2110X15B (Korea) The Trilogy Evo ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. - Used this ventilator: Trilogy EVO 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. Run your business as you see fit, customizing reports and alerts to aid in identifying patients at risk and provide them with timely care. 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. 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. A team of engineers, scientists, and clinicians of Nihon Kohden OrangeMed Inc, the . Trilogy Evo provides noninvasive and invasive ventilator support with added sensitivity for a wide range of adult and pediatric patients. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Trilogy Evo is versatile enough that it allows for use across multiple care settings and easy transitions. 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. Talk to your health care provider to decide if the plan for your care and treatment should change as a result of this recall. 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. More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov. Koninklijke Philips N.V., 2004 - 2023. Release certain chemicals, such as VOCs into the device's air tubes and be inhaled by the user. There is no required component replacement, and can be serviced with standard service tools. Trilogy Evo has a four-year service interval. At this time, the information provided by Philips has not established that the filters can reduce the PE-PUR foam's risks. Trilogy 100 (ventilator) Trilogy 200 (ventilator) Philips also recalled certain Trilogy Evo ventilators distributed from April 15, 2021 to May 24, 2021 with specific serial numbers.. The FDA continues to review and assess the MDRs and will keep the public informed as new information becomes available. Determine if any Trilogy Evo devices have been repaired using Trilogy Evo Muffler Assembly Part Number 1135357 starting 14 April 2021 or later. All rights reserved. The .gov means its official.Federal government websites often end in .gov or .mil. *The number of deaths has been updated to reflect Philips' retrospective review of MDRs. Flexibility of circuits allows it to be used in a wide range of patients. six-hour battery, Trilogy Evo gives patients a new level of freedom and mobility. It assists with ventilator to patient synchrony and comfort without manual adjustments. Malviya Nagar 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. You are about to visit a Philips global content page. If you have additional concerns, talk to your health care provider about the plan for your care and treatment. This is a 10-pack of particulate filters for use with the Trilogy Evo and Trilogy EV300 ventilators. For use in dynamic environments. Trilogy Evo provides noninvasive and invasive ventilator support with added sensitivity for a wide range of adult and pediatric patients. Trilogy-Clinical-Manual. We are always interested in engaging with you. 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. Philips submitted 30 MDRs between 2011-April 2021 that they identified as associated with the PE-PUR foam degradation (breakdown). SpO2, EtCO2 and advanced respiratory mechanics monitoring capabilities are designed to help you optimize your patients therapy. 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 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. Inline bacterial filters may increase the resistance to air flow through the device, which could mean the ventilator will not ventilate adequately. Transfer data wirelessly to the cloud with safe, secure, connectivity with the Trilogy hub. The MDRs received included both mandatory reports from Philips and voluntary reports from health professionals, consumers, and patients. At this time, the FDA is not changing the recommendations from the previous June 2021 safety communication. Long-lasting battery lifeVentilator-dependent patients are supported by internal and detachable batteries, now with 15-hour battery life. This Trilogy Ventilator Carrier measures 12 Wide x 13 Long x 8 High. Trilogy Evo is designed for easy navigation and fast set-up of prescriptions. eLearning. Connected Trilogy provides remote viewing of key ventilation parameters, alarm data, device performance and patient usage. Increase your teams efficiencies and streamline your workflow for a sharper focus on higher clinical priorities. In June 2021, Philips recalled certain ventilators, BiPAP machines, and CPAP machines (see table below) because of potential health risks. All Rights Reserved. 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. 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. 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. Trilogy Evo uses Bluetooth to send you patient and device data through Care Orchestrator, our cloud-based tool. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Trilogy Evo is the only industry-leading ventilator with 15 hours of battery life with an internal and detachable battery. We encourage consumers to contact Philips to get an update on the status of their replacement device. 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. You can also download data at the point of care through a USB drive. Irritation to the skin, eyes, nose, and respiratory tract (airway), Toxic or cancer-causing effects to organs, such as kidneys and liver, Irritation in the eyes, nose, respiratory tract (airway), and skin, Hypersensitivity reaction, such as an allergic reaction or another immune system reaction. Versus Trilogy 100 and 200, 1. Digital Auto-Trak provides an automated breath triggering and cycling algorithm that adjusts to the patients natural breathing patterns. If the lot number used in repair is between 210414 and 210524. Koninklijke Philips N.V., 2004 - 2023. 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). Digital Auto-Trak provides an automated breath triggering and cycling algorithm that adjusts to the patients natural breathing patterns. Ventilator-dependent patients are supported by internal and detachable batteries, now with 15-hour battery life. Pressure and volume ventilation delivers through a controlled Flexibility of circuits allows it to be used in a wide range of 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 . The Trilogy EVO Ventilator is a cross-functional machine designed specifically for use in multiple environments, including travel. The breakdown of the PE-PUR foam may result from exposure to hot and humid conditions. It's designed specifically with durability in mind to protect it against damage during travel, such as during medical transport. A complete list of affected devices is available in the Medical Device Recalls database. Comprehensive, clinically relevant courses to help enhance operational efficiency and provide high-quality patient care. You are about to visit a Philips global content page. Before sharing sensitive information, make sure you're on a federal government site. 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