A replacement Trilogy Evo ventilator will be provided by Philips. Follow Philips' instructions for recommended cleaning of your CPAP machine and accessories. Remotely monitor and manage all of your sleep apnea and respiratory patients with a single system. This solution is designed to unite the technologies, resources, people and information essential to manage your respiratory patients. We encourage consumers to contact Philips to get an update on the status of their replacement device. Compared to Trilogy 100's There were no reports of patient injury or death among those 30 MDRs. More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov. *Nominal run time per method in International Electrotechnical Commission (7.5 hour/battery). This learning curriculum is part of a clinical education program that enables clinical providers, caregivers and patients to develop their Trilogy Evo skills. You are about to visit a Philips global content page. CPAP Full Face Masks. eLearning. 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. 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. *Nominal run time per method in International Electrotechnical Commission (7.5 hour/battery). Your provider may advise you to: Stop using your recalled device (see How to Know if You Should Stop Using Your Device in. The company formally submitted their Report of Correction and Removal (a report under 21 CFR part 806, or "806 report") in June 2021. Its designed specifically with durability in mind to protect it against damage during travel, such as during medical transport. The Philips Respironics Trilogy 202 is both a volume-control & pressure-control ventilator for invasive and noninvasive ventilation. 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. Ventilator-dependent patients are supported by internal and detachable batteries, now with 15-hour battery life. 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 intended for pediatric through adult patients weighing at least 2.5 kg. Philips will replace the device these parts were installed into. data fl ow, Trilogy Evo helps benefi t a broad spectrum of patients, from newborns to adults. We are always interested in engaging with you. 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. Release certain chemicals, such as VOCs into the device's air tubes and be inhaled by the user. Contact Philips for next steps. We are always interested in engaging with you. Trilogy Evo provides noninvasive and invasive ventilator support with added sensitivity for a wide range of adult and pediatric patients. 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. Trilogy Evo provides noninvasive and invasive ventilator support with added sensitivity for a wide range of adult and pediatric patients. With Care Orchestrator, you have the power to create custom health rules based on your best practices and proven processes. The filters protect patients from impurities in the air, the ventilator from corrosion, and healthcare professionals from exhaled pathogens and medication remnants. For more information on the company's recall notification, contact your local Philips representative or visit Philips' recall notification web page. Add to my planner. 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. "Connect with Philips Online: - Visit Philips Sleep and Respiratory Care Website: www.philips.com/healthcare/solutions/sleep-and-respiratory-care- Find Phili. 110017, New Delhi SpO2, EtCO2 and advanced respiratory mechanics monitoring capabilities are designed to help you optimize your patients therapy. All rights reserved. Digital Auto-Trak provides an automated breath triggering and cycling algorithm that adjusts to the patient's natural breathing patterns. 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. a wide range of patients. It's ready to be mounted onto a roll-stand or a wheelchair, with a mountable, easy- Although MDRs are a valuable source of information, this passive surveillance system has limitations. The Trilogy Evo trainings are designed for both Healthcare Professionals and Caregivers or users of the Trilogy Evo. 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. It offers new, on-screen Help and Alarm guidance and user-friendly universal names for most ventilation modes. 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 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. 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). Trilogy Evo uses Bluetooth to send you patient and device data through Care Orchestrator, our cloud-based tool. For use in dynamic environments. It's ready to be mounted onto a roll-stand or a wheelchair, with a mountable, easy- The FDA posted answers to frequently asked questions about this recall: FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls. Volume and pressure modes, AVAPS-AE, SpO2 and EtCO2 monitoring and alarms of every parameter allow for adaptable care. Trilogy Evo provides noninvasive and invasive ventilator support with added sensitivity for a wide range of adult and pediatric patients. Every Trilogy Evo is equipped to connect with Care Orchestrator, and you can download data wirelessly or via the USB port. Please navigate to the training sections most relevant to you. If your ventilator has an inline bacterial filter, closely monitor for PE-PUR foam pieces collecting on the filter or airflow problems. The Philips Respironics Trilogy 202 is both a volume-control & pressure-control ventilator for invasive and non-invasive ventilation. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Printing and scanning is no longer the best way to manage documents. Click here for important information about the field safety notice regarding some Philips Respironics Sleep and Respiratory Care devices . Flexibility of circuits allows it to be used in a wide range of patients. With Care Orchestrator, you have the power to create custom health rules based on your best practices and proven processes. Award-winning service delivered in ways that promote your clinical, operational and technical success. Increase your teams efficiencies and streamline your workflow for a sharper focus on higher clinical priorities. This solution is designed to unite the technologies, resources, people and information essential to manage your respiratory patients. Comprehensive, clinically relevant courses to help enhance operational efficiency and provide high-quality patient care. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. 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. Please review the, 7 Questions to Ask Your Doctor and Pharmacist About COPD Medications. Trilogy Evo has a four-year service interval. For more information, please see the Potential Health Risks from Sound Abatement Foam section of the Update: Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication. The FDA is aware that patients have already received devices with silicone-based foam as part of the repair and replace program. 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 mouthpiece ventilation does not require any inspiratory effort in order to trigger a breath. A/C-VC modeActivePAPcircuit, PEEP 3cmH2O andVt800ml. 2. The MDRs received included both mandatory reports from Philips and voluntary reports from health professionals, consumers, and patients. The newest Trilogy device was made to be user-friendly without compromising the advanced features of the innovative Trilogy family technology. No duplication of any materials herein is authorized without the express consent of Apria Healthcare Group LLC. Koninklijke Philips N.V., 2004 - 2023. Long-lasting battery lifeVentilator-dependent patients are supported by internal and detachable batteries, now with 15-hour battery life. Available with Trilogy Evo O2 only 2. Comprehensive, advanced NIV therapy modes include AVAPS-AE5 and mouthpiece ventilation (MPV), while invasive ventilation is available with single and dual limb circuits and leak compensation. Proven innovations are designed to treat the varying needs of respiratory insufficiency. 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). With BARDA's continuing support, Philips finally won FDA approval for the Trilogy Evo Universal ventilator in July 2019. Trilogy-100-Ventilator-Information-and-User-Guide. Run your business as you see fit, customizing reports and alerts to aid in identifying patients at risk and provide them with timely care. Connected Trilogy provides remote viewing of key ventilation parameters, alarm data, device performance and patient usage. 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. 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. Visit this page often to view additional basic and advanced trainings as they become available. It is compatible with a range of accessories to provide a variety of therapy modes. 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. 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. Features. 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. Inspect and clean the patient circuit and accessories per the instructions included with the notification. Trilogy Evo uses Bluetooth to send you patient and device data through Care Orchestrator, our cloud-based tool. In addition to usage rates, other Connected Trilogy Health Rules can be set for gross change and absolute threshold settings including: Additionally, Philips observed residual PEPUR sound abatement foam in some reworked Trilogy 100 and Trilogy 200 ventilators that were returned to customers. Trilogy Evo Quick Start Guide for caregivers with step by step instructions. / ( / ) 5% FiO 2 The mouthpiece ventilation does not require any inspiratory effort in order to trigger a breath. Flexibility of circuits allows it to be used in a wide range of patients. 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. The site is secure. All Rights Reserved. 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. This interactive module will provide you will an overview of the Trilogy Evo ventilator including how to initiate ventilation and navigate through the windows. Proven innovations are designed to treat the varying needs of respiratory insufficiency. 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 Evo needs preventive maintenance only every four years, and minimal equipment for calibration. Philips submitted 30 MDRs between 2011-April 2021 that they identified as associated with the PE-PUR foam degradation (breakdown). Pressure and volume ventilation delivers through a controlled 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. Volume and pressure modes, AVAPS-AE, SpO2 and EtCO2 monitoring and alarms of every parameter allow for adaptable care. 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. 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. 2. 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. See the latest FDA Actions in the FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls. Trilogy Evo provides noninvasive and invasive ventilator support with added sensitivity for a wide range of adult and pediatric 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. 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. 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 certificate. Versatile breath delivery and setup options provide greater continuity of care. Trilogy Evo is designed for easy navigation and fast set-up of prescriptions. At this time, the information provided by Philips has not established that the filters can reduce the PE-PUR foam's risks. It offers new, on-screen Help and Alarm guidance and user-friendly universal names for most ventilation modes. Customers are instructed to: 1) Compare the serial numbers of their device(s) to Attachment A: List of . Ventilator-dependent patients are supported by internal and detachable batteries, now with 15-hour battery life. Trilogy-100-Ventilator-Information-and-User-Guide. By clicking on the link, you will be leaving the official Royal Philips ("Philips") website. Do not use any quarantined material and contact Philips for return instructions. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. 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. Change filter (may be blocked with powder, smoke, dust, etc.) a wide range of patients. Trilogy Evo is versatile enough that it allows for use across multiple care settings and easy transitions. 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. The issue was identified during lab testing of the Trilogy Evo ventilator. 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). It assists with ventilator to patient synchrony and comfort without manual adjustments.