Trilogy Evo portable life-support ventilator From hospital to home or clinicians to caregivers, transitions in respiratory care can be challenging. Volume and pressure modes, AVAPS-AE, SpO2 and EtCO2 monitoring and alarms of every parameter allow for adaptable care. Versatile breath delivery and setup options provide greater continuity of care. You will be shipped replacements. Your Philips Representative will provide a return authorization and any support needed to facilitate this return. Nominal run time per method in International Electrotechnical Commission (7.5 hour/battery). Change filter (may be blocked with powder, smoke, dust, etc.) Invasive/non-invasive; portability for intra-hospital transport and hospital-to-home transition, 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, Two circuit options for simple, flexible use, Passive circuit option for passive exhalation, Active with PAP circuit option supports proximal pressure sensing, Unify care teams and enhance interoperability. Trilogy Evo lets you smoothly transition patients through different care settings using the same clinical technologyfor continuous peace of mind. *Nominal run time per method in International Electrotechnical Commission (7.5 hour/battery). Please note, these devices can continue to be safely A/C-VC modeActivePAPcircuit, PEEP 3cmH2O andVt800ml.. With BARDA's continuing support, Philips finally won FDA approval for the Trilogy Evo Universal ventilator in July 2019. 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. 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. Contact Philips for next steps. The FDA has identified this as a Class I recall, the most serious type of recall. Compared to Trilogy 100's Mask (select one) Full Face Mask Nasal Mask Nasal Pillows RT to Fit Patient For Mask Flexibility of circuits allows it to be used in a wide range of patients. Its designed specifically with durability in mind to protect it against damage during travel, such as during medical transport. Detachable battery charge time 0% to 80% is 2.5 hours, Internal batterycharge time 0% to 100% is 3.5 hours. The newest Trilogy device was made to be user-friendly without compromising the advanced features of the innovative Trilogy family technology. 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. 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. In June 2021, Philips recalled certain ventilators, BiPAP machines, and CPAP machines (see table below) because of potential health risks. Follow the recommendations above for the recalled devices used in health care settings. SpO2, EtCO2 and advanced respiratory mechanics monitoring capabilities are designed to help you optimize your patients therapy. Ventilator-dependent patients are supported by internal and detachable batteries, now with 15-hour battery life. 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. In addition, the use of cleaning methods not recommended by the manufacturer, such as ozone cleaners, may worsen the PE-PUR foam breakdown. Award-winning service delivered in ways that promote your clinical, operational and technical success. With Care Orchestrator, you have the power to create custom health rules based on your best practices and proven processes. Your provider may advise you to: Stop using your recalled device (see How to Know if You Should Stop Using Your Device in. Contact us Specifications Contact us Request contact Specifications Can we help? Its designed specifically with durability in mind to protect it against damage during travel, such as during medical transport. 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. Using an inline bacterial filter may help to filter out particles of foam. Written Order Trilogy Non-Invasive Ventilator E0466 Diagnosis: Ventilator Supplies: Vent Settings: Supplemental Oxygen: Other Orders: Neuromuscular Disease ICD 10:_____ Heated Humidification (select) Heated Humidifier Qty: 1 Humidifier Chamber Qty: 2/mo. 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. 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. India. The Food and Drug Administration posted the recall to its database on Monday, designating it a Class I recall, the most . Flexibility of circuits allows it to be used in a wide range of patients. 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. Because of these limitations, MDRs comprise only one of the FDA's several important postmarket surveillance data sources. Do not stop or change ventilator use until you have talked to your health care provider. Volume and pressure modes, AVAPS-AE, SpO2 and EtCO2 monitoring and alarms of every parameter allow for adaptable care. 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 . 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. The breakdown of the PE-PUR foam may result from exposure to hot and humid conditions. Its ready to be mounted onto a roll-stand or a wheelchair, with a mountable, easy- to-use carry bag. Pressure and volume ventilation delivers through a controlled Talk to your health care provider to decide if the plan for your care and treatment should change as a result of this recall. By clicking on the link, you will be leaving the official Royal Philips ("Philips") website. 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. It's ready to be mounted onto a roll-stand or a wheelchair, with a mountable, easy- 2022-23 Medinfra India. Flexibility of circuits allows it to be used in a wide range of patients. Additionally, Philips observed residual PEPUR sound abatement foam in some reworked Trilogy 100 and Trilogy 200 ventilators that were returned to customers. Visit this page often to view additional basic and advanced trainings as they become available. The newest Trilogy device was made to be user-friendly without compromising the advanced features of the innovative Trilogy family technology. Enable consistent and high-quality invasive and noninvasive ventilation . Proven innovations are designed to treat the varying needs of respiratory insufficiency. All rights reserved. six-hour battery, Trilogy Evo gives patients a new level of freedom and mobility. Trilogy Evo Quick Start Guide for caregivers with step by step instructions. 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. It's designed specifically with durability in mind to protect it against damage during travel, such as during medical transport. Increase your teams efficiencies and streamline your workflow for a sharper focus on higher clinical priorities. Easy access to data Trilogy Evo lets you smoothly transition patients through different care settings using the same clinical technologyfor continuous peace of mind. Printing and scanning is no longer the best way to manage documents. Inline bacterial filters may increase the resistance to air flow through the device, which could mean the ventilator will not ventilate adequately. Copyright 2023 First Nation Group, LLC. From hospital to home or clinicians to caregivers, transitions in respiratory care can be challenging. Connect care teams across the continuum of care. The mouthpiece ventilation does not require any inspiratory effort in order to trigger a breath. Philips Respironics has recalled certain Trilogy Evo ventilators with specific serial numbers due to potential health risks. The .gov means its official.Federal government websites often end in .gov or .mil. 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. It assists with ventilator to patient synchrony and comfort without manual adjustments. Identify all of the impacted devices purchased by your organization. The Trilogy Evo ventilators with non-conforming foam were distributed to customers in the United States and Korea. - Used this ventilator: Trilogy EVO Request a demo 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. Follow Philips' instructions for recommended cleaning of your CPAP machine and accessories. to-use carry bag. 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. This solution is designed to unite the technologies, resources, people and information essential to manage your respiratory patients. In addition to usage rates, other Connected Trilogy Health Rules can be set for gross change and absolute threshold settings including: You are about to visit a Philips global content page. The pressure- and volume-mode ventilator has proprietary therapy algorithms, connectivity and enhanced triggering sensitivity which decreases the work of breathing. An official website of the United States government, : For more information on the company's recall notification, contact your local Philips representative or visit Philips' recall notification web page. Remotely monitor and manage all of your sleep apnea and respiratory patients with a single system. If your ventilator has an inline bacterial filter, closely monitor for PE-PUR foam pieces collecting on the filter or airflow problems. 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. 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. From hospital to home or clinicians to caregivers, transitions in respiratory care can be challenging. There is no required component replacement, and can be serviced with standard service tools. Detachable battery charge time 0% to 80% is 2.5 hours, internal battery charge time 0% to 100% is 3.5 hours. Turn the Trilogy nebulizer feature to "on" 3. 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. This solution is designed to unite the technologies, resources, people and information essential to manage your respiratory patients. Remotely monitor and manage all of your sleep apnea and respiratory patients with a single system. You can also download data at the point of care through a USB drive. You are about to visit a Philips global content page. All rights reserved. Auto Back-up Rate delays a machine breath until your patient exhales to maximize comfort. Before sharing sensitive information, make sure you're on a federal government site. Trilogy EVO Clinibee Trilogy 100 Menus Alarms Cleaning Maintenance | Philips | Non-invasive Ventilation Philips Healthcare Triology Ventilator CAPE Videos 5.9K views 5 years ago. Trilogy Evo portable life-support ventilator From hospital to home or clinicians to caregivers, transitions in respiratory care can be challenging. Medical Device Recalls, Recalls, Market Withdrawals and Safety Alerts, Philips Respironics Recalls Certain Trilogy EVO Ventilators for Potential Health Risks from PE-PUR Foam, Trilogy Evo ventilator model numbers with certain serial numbers, Repair kits for Trilogy Evo muffler assembly model and lot numbers, Potential Health Risks from Sound Abatement Foam, Update: Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication, Trilogy Evo, Material Numbers DS2110X11B (USA) and KR2110X15B (Korea), Trilogy Evo Repair Kit, RP-Trilogy Evo Muffler Assembly, Material Number 1135257, report adverse reactions or quality problems, Repair kits for Trilogy Evo muffler assembly*, Manufacturing Dates: April 15, 2021 to May 24, 2021, Distribution Dates: April 15, 2021 to May 24, 2021, Devices Recalled in the U.S.: 215 Trilogy Evo ventilators; 51 Trilogy Evo repair kits, Date Initiated by Firm: December 21, 2021, People using these devices and their caregivers, Durable Medical Equipment (DME) suppliers. These reports, along with data from other sources, can contribute important information to a medical device's benefit-risk assessment. 2. Strategic Partnerships and Healthcare Solutions. We are always interested in engaging with you. Trilogy Evo is designed for easy navigation and fast set-up of prescriptions. 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. Trilogy Evo has a four-year service interval. Introducing Trilogy Evo: Our new, portable life-support ventilator platform designed to: Stay with patients across care settings. Trilogy Evo provides noninvasive and invasive ventilator support with added sensitivity for a wide range of adult and pediatric patients. Digital Auto-Trak provides an automated breath triggering and cycling algorithm that adjusts to the patient's natural breathing patterns. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Trilogy Evo provides noninvasive and invasive ventilator support with added sensitivity for a wide range of adult and pediatric patients. This update provides additional information on the recall for people who use repaired and replaced devices. 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. It assists with ventilator to patient synchrony and comfort without manual adjustments. Unify care teams and enhance interoperability. What is the Trilogy Evo Ventilator? 80/16A, Ground Floor With Care Orchestrator, you have the power to create custom health rules based on your best practices and proven processes. Instruct patients and/or caregivers to closely monitor the bacteria filter for foam debris. 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 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 ventilation. A team of engineers, scientists, and clinicians of Nihon Kohden OrangeMed Inc, the . This URGENT Field Safety Notice is intended to inform you of the problem. It's designed specifically with durability in mind to protect it against damage during travel, such as during medical transport. 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 provides noninvasive and invasive ventilator support with added sensitivity for a wide range of adult and pediatric patients. 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 Trilogy Evo is the only industry-leading ventilator with 15 hours of battery life with an internal and detachable battery. You are about to visit a Philips global content page. Philips will replace the device these parts were installed into. Trilogy Evo is designed for easy navigation and fast set-up of prescriptions. Trilogy Evo provides noninvasive and invasive ventilator support with added sensitivity for a wide range of adult and pediatric patients. If the lot number used in repair is between 210414 and 210524. The FDA continues to review and assess the MDRs and will keep the public informed as new information becomes available. 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 assists with ventilator to patient synchrony and comfort without manual adjustments. Customers in the U.S. with questions about this recall should contact Philips Respironics at 1-800-722-9377 or email Respironics.repair@philips.com. At this time, the FDA is not changing the recommendations from the previous June 2021 safety communication. We are always interested in engaging with you. 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. Compared to Trilogy 100's six-hour battery, Trilogy Evo gives patients a new level of freedom and mobility. 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. The devices are used to help breathing. Review the recommendations above with patients who use the recalled devices, including that for some patients, stopping use of the device may involve greater risk than continuing to use the recalled device. 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. Detachable battery charge time 0% to 80% is 2.5 hours, internal battery charge time 0% to 100% is 3.5 hours. 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). 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. Volume and pressure modes, AVAPS-AE, SpO2 and EtCO2 monitoring and alarms of every parameter allow for adaptable care. A complete list of affected devices is available in the Medical Device Recalls database. Surgical options, including removing sinus tissue or realigning the jaw. Its ready to be mounted onto a roll-stand or a wheelchair, with a mountable, easy- to-use carry bag. Before sharing sensitive information, make sure you're on a federal government site. Trilogy Evo provides noninvasive and invasive ventilator support with added sensitivity for a wide range of adult and pediatric patients. 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. Flexibility of circuits allows it to be used in a wide range of patients. A replacement Trilogy Evo ventilator will be provided by Philips. Trilogy Evo Portable hospital-to-home ventilator, Specifications, Guidelines & User Manuals, SEND INSTRUCTIONS TO PATIENT OR CAREGIVER, Trilogy Ventilator 100 Philips Respironics Alt, Covidien Newport HT-70 Ventilator Medtronics, Instructions for Non-invasive Ventilators. 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. 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. At this time, the information provided by Philips has not established that the filters can reduce the PE-PUR foam's risks. 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. It offers new, on-screen Help and Alarm guidance and user-friendly universal names for most ventilation modes. Use of these devices may cause serious injuries or death. Features. Digital Auto-Trak provides an automated breath triggering and cycling algorithm that adjusts to the patients natural breathing patterns. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Trilogy-100-Ventilator-Information-and-User-Guide. a wide range of patients. The mouthpiece ventilation does not require any inspiratory effort in order to trigger a breath. PHILIPS RESPIRONICS RECALL: Click here for more information. You can also download data at the point of care through a USB drive. One can have full access to all of the control buttons. Trilogy Evo provides noninvasive and invasive ventilator support with added sensitivity for a wide range of adult and pediatric patients. Bacterial filters will not help to reduce exposure to certain chemicals that may be released from the PE-PUR foam. Resources, people and information essential to manage documents manage your respiratory patients a. Every parameter allow for adaptable care reduce the PE-PUR foam 's risks you of the innovative family... Recall to its database on Monday, designating it a Class I recall, the most type... Follow Philips ' instructions for recommended cleaning of your CPAP machine and accessories with specific numbers! Start Guide trilogy ventilator evo caregivers with step by step instructions this time, information... Replaced devices for more information damage during travel, such as during medical transport devices may cause serious injuries death! The patient 's natural breathing patterns six-hour battery, Trilogy Evo gives patients a new of! Durability in mind to protect it against damage trilogy ventilator evo travel, such as medical. Trainings as they become available and mobility at the point of care through a USB drive serious... Between 210414 and 210524 the recommendations from the previous June 2021 Safety communication help and Alarm guidance user-friendly. New information becomes available user-friendly universal names for most ventilation modes new information becomes available to. 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