This update provides additional information on the recall for people who use repaired and replaced devices. 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. SpO2, EtCO2 and advanced respiratory mechanics monitoring capabilities are designed to help you optimize your patients therapy. Flexibility of circuits allows it to be used in Trilogy Evo is designed for easy navigation and fast set-up of prescriptions. Compared to Trilogy 100's 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 . Pressure and volume ventilation delivers through a controlled In June 2021, Philips recalled certain ventilators, BiPAP machines, and CPAP machines (see table below) because of potential health risks. Auto Back-up Rate delays a machine breath until your patient exhales to maximize comfort. 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. An official website of the United States government, : Proven innovations are designed to treat the varying needs of respiratory insufficiency. This learning curriculum is part of a clinical education program that enables clinical providers, caregivers and patients to develop their Trilogy Evo skills. Flexibility of circuits allows it to be used in a wide range of patients. Versatile breath delivery and setup options provide greater continuity of care. This material is not intended to substitute or replace the Operating Manual or Instructions for Use. 2. six-hour battery, Trilogy Evo gives patients a new level of freedom and mobility. You can also download data at the point of care through a USB drive. These reports, along with data from other sources, can contribute important information to a medical device's benefit-risk assessment. Although MDRs are a valuable source of information, this passive surveillance system has limitations. Easy access to data Enable consistent and high-quality invasive and noninvasive ventilation . Compared to Trilogy 100's six-hour battery, Trilogy Evo gives patients a new level of freedom and mobility. It's ready to be mounted onto a roll-stand or a wheelchair, with a mountable, easy- 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. 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. Remotely monitor and manage all of your sleep apnea and respiratory patients with a single system. Auto Back-up Rate delays a machine breath until your patient exhales to maximize comfort. Versus Trilogy 100 and 200, 1. 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. to-use carry bag. 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. Click here for important information about the field safety notice regarding some Philips Respironics Sleep and Respiratory Care devices . Trilogy Evo Quick Start Guide for caregivers with step by step instructions. Trilogy Evo provides noninvasive and invasive ventilator support with added sensitivity for a wide range of adult and pediatric patients. It is an electronically controlled, pneumatic ventilation system with an integrated air compressing system. 110017, New Delhi Digital Auto-Trak provides an automated breath triggering and cycling algorithm that adjusts to the patients natural breathing patterns. We are always interested in engaging with you. Detachable battery charge time 0% to 80% is 2.5 hours, internal battery charge time 0% to 100% is 3.5 hours. Follow the recommendations above for the recalled devices used in health care settings. Trilogy-100-Ventilator-Information-and-User-Guide. Trilogy Evo portable life-support ventilator. Medinfra India Pvt. 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. Detachable battery charge time 0% to 80% is 2.5 hours, Internal batterycharge time 0% to 100% is 3.5 hours. Instructions include video demonstrations and user manuals for respiratory therapy Read more For privacy reasons YouTube needs your permission to be loaded. Koninklijke Philips N.V., 2004 - 2023. This URGENT Field Safety Notice is intended to inform you of the problem. 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. You will be shipped replacements. 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. Please navigate to the training sections most relevant to you. Trilogy Evo needs preventive maintenance only every four years, and minimal equipment for calibration. The mouthpiece ventilation does not require any inspiratory effort in order to trigger a breath. 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. 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. We encourage consumers to contact Philips to get an update on the status of their replacement device. The newest Trilogy device was made to be user-friendly without compromising the advanced features of the innovative Trilogy family technology. Quick links to help you find what you need or see how to get in touch with a customer service representative. 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). In addition, the use of cleaning methods not recommended by the manufacturer, such as ozone cleaners, may worsen the PE-PUR foam breakdown. The notification requested customers take the following actions: For the repair kit for Trilogy Evo muffler assembly, the December 21, 2021, notification letter requested customers take the following actions: For more information, please see the Recommendations section of the Update: Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication. This solution is designed to unite the technologies, resources, people and information essential to manage your respiratory patients. All rights reserved. Connect care teams across the continuum of care. Trilogy Evo has a four-year service interval. a wide range of patients. Easy access to data You are about to visit a Philips global content page. Unify care teams and enhance interoperability. 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. This interactive module will provide you will an overview of the Trilogy Evo ventilator including how to initiate ventilation and navigate through the windows. By clicking on the link, you will be leaving the official Royal Philips ("Philips") website. Trilogy 200 helps care teams provide quality respiratory care while meeting patients evolving needs. 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. 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 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. Follow Philips' instructions for recommended cleaning of your CPAP machine and accessories. Your Philips Representative will provide a return authorization and any support needed to facilitate this return. One can have full access to all of the control buttons. 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 You are about to visit a Philips global content page. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. PE-PUR foam is used to lessen sound and vibration in these devices and other medical equipment. The .gov means its official.Federal government websites often end in .gov or .mil. 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. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Its designed specifically with durability in mind to protect it against damage during travel, such as during medical transport. 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. Drive collaboration among your care team with actionable patient insights delivered straight to their smart phones, tablets, or PCs. Trilogy Evo uses Bluetooth to send you patient and device data through Care Orchestrator, our cloud-based tool. Your provider may advise you to: Stop using your recalled device (see How to Know if You Should Stop Using Your Device in. A problem has been identified within the Philips Respironics Trilogy Evo 02, Trilogy Evo Universal, and Trilogy EV300 ventilators that could pose a risk for patients if not mitigated. Comprehensive, clinically relevant courses to help enhance operational efficiency and provide high-quality patient care. By clicking on the link, you will be leaving the official Royal Philips ("Philips") website. 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 . Award-winning service delivered in ways that promote your clinical, operational and technical success. 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