Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Identify all of the impacted devices purchased by your organization. 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. For use in dynamic environments. 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. Nominal run time per method in International Electrotechnical Commission (7.5 hour/battery). Proven innovations are designed to treat the varying needs of respiratory insufficiency. Do not stop or change ventilator use until you have talked to your health care provider. The Trilogy Evo was developed specifically for use in its respective environment. 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. It assists with ventilator to patient synchrony and comfort without manual adjustments. Run your business as you see fit, customizing reports and alerts to aid in identifying patients at risk and provide them with timely care. 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. These Philips Trilogy 100 and Trilogy 2000 ventilators were a part of this recall in June 2021 for issues with the polyester-based polyurethane (PE-PUR) sound abatement foam breakdown. 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. We are always interested in engaging with you. Your provider may advise you to: Stop using your recalled device (see How to Know if You Should Stop Using Your Device in. Nominal run time per method in InternationalElectrotechnicalCommission (7.5 hr/battery). 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. Trilogy Evo is the only industry-leading ventilator with 15 hours of battery life with an internal and detachable battery. Its ready to be mounted onto a roll-stand or a wheelchair, with a mountable, easy- to-use carry bag. Ventilator-dependent patients are supported by internal and detachable batteries, now with 15-hour battery life. 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). 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 ventilator is suitable for use in institutional, home, and non-emergency transport settings, for example wheelchair or personal vehicle. eLearning. Once the patient has been transitioned, return the affected Trilogy Evo ventilator to Philips. All rights reserved. six-hour battery, Trilogy Evo gives patients a new level of freedom and mobility. Easy access to data Digital Auto-Trak provides an automated breath triggering and cycling algorithm that adjusts to the patients natural breathing patterns. 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. Connect care teams across the continuum of care. A team of engineers, scientists, and clinicians of Nihon Kohden OrangeMed Inc, the . Unify care teams and enhance interoperability. Long-lasting battery lifeVentilator-dependent patients are supported by internal and detachable batteries, now with 15-hour battery life. Proven PerformancePhilips Respironics Trilogy EVO (OBM) Portable Ventilator. Introducing Trilogy Evo: Our new, portable life-support ventilator platform designed to: Stay with patients across care settings. 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. Trilogy Evo provides noninvasive and invasive ventilator support with added sensitivity for a wide range of adult and pediatric patients. By clicking on the link, you will be leaving the official Royal Philips ("Philips") website. Philips will replace the device these parts were installed into. Medinfra India Pvt. Connected Trilogy provides remote viewing of key ventilation parameters, alarm data, device performance and patient usage. Proven innovations are designed to treat the varying needs of respiratory insufficiency. Trilogy Evo provides noninvasive and invasive ventilator support with added sensitivity for a wide range of adult and pediatric patients. 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. Before sharing sensitive information, make sure you're on a federal government site. Koninklijke Philips N.V., 2004 - 2023. Versatile breath delivery and setup options provide greater continuity of care. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. An online platform to manage and service your Philips products and related services across modalities - all at no additional cost. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Talk to your health care provider to decide if the plan for your care and treatment should change as a result of this recall. 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. 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. Detachable battery charge time 0% to 80% is 2.5 hours, internal battery charge time 0% to 100% is 3.5 hours. It is an electronically controlled, pneumatic ventilation system with an integrated air compressing system. 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. Code Information. 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". It offers new, on-screen Help and Alarm guidance and user-friendly universal names for most ventilation modes. *Nominal run time per method in International Electrotechnical Commission (7.5 hour/battery). 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 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. Run your business as you see fit, customizing reports and alerts to aid in identifying patients at risk and provide them with timely care. 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. 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. 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 uses Bluetooth to send you patient and device data through Care Orchestrator, our cloud-based tool. The FDA continues to review and assess the MDRs and will keep the public informed as new information becomes available. Detachable battery charge time 0% to 80% is 2.5 hours, internal battery charge time 0% to 100% is 3.5 hours. You are about to visit a Philips global content page. Patients who have additional concerns should talk to their health care provider about the plan for their care and treatment. 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. 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. 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. 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. 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 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. Instruct patients and/or caregivers to closely monitor the bacteria filter for foam debris. These issues could potentially result in serious injury and require medical intervention to prevent permanent injury. What is the Trilogy Evo Ventilator? Trilogy Evo portable life-support ventilator From hospital to home or clinicians to caregivers, transitions in respiratory care can be challenging. *Nominal run time per method in International Electrotechnical Commission (7.5 hour/battery). 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. Its ready to be mounted onto a roll-stand or a wheelchair, with a mountable, easy- to-use carry bag. This is a 10-pack of particulate filters for use with the Trilogy Evo and Trilogy EV300 ventilators. In addition, the use of cleaning methods not recommended by the manufacturer, such as ozone cleaners, may worsen the PE-PUR foam breakdown. CPAP Full Face Masks. With BARDA's continuing support, Philips finally won FDA approval for the Trilogy Evo Universal ventilator in July 2019. The .gov means its official.Federal government websites often end in .gov or .mil. 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. A/C-VC modeActivePAPcircuit, PEEP 3cmH2O andVt800ml. 2. *Nominal run time per method in International Electrotechnical Commission (7.5 hour/battery). 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. From hospital to home or clinicians to caregivers, transitions in respiratory care can be challenging. A full face CPAP mask is any mask system that covers both the mouth and the nose to deliver air for the PAP treatment. Auto Back-up Rate delays a machine breath until your patient exhales to maximize comfort. With Care Orchestrator, you have the power to create custom health rules based on your best practices and proven processes. These reports, along with data from other sources, can contribute important information to a medical device's benefit-risk assessment. 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. It offers new, on-screen Help and Alarm guidance and user-friendly universal names for most ventilation modes. 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. Comprehensive, clinically relevant courses to help enhance operational efficiency and provide high-quality patient care. Trilogy Evo provides noninvasive and invasive ventilator support with added sensitivity for a wide range of adult and pediatric patients. Trilogy Evo Trilogy Evo O2 Trilogy 100 Trilogy 200 Philips Hospital/Home Ventilation Solutions 1. Flexibility of circuits allows it to be used in a wide range of patients. Volume and pressure modes, AVAPS-AE, SpO2 and EtCO2 monitoring and alarms of every parameter allow for adaptable care. The FDA's in-depth review and analysis of these new MDRs will include examining the possible reasons for the increased number of reports. Strategic Partnerships and Healthcare Solutions. Philips will replace the device these parts were installed into. Its designed specifically with durability in mind to protect it against damage during travel, such as during medical transport. The NKV-550 ventilator with Protective Control is the only critical care ventilator, at the time of this press release, that has received US FDA's 510(k) clearance for this feature, a review process more rigorous than the FDA's Emergency Use Authorization. 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. 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 very user-friendly as kind of a "mini V60" with simplicity in setting pressure and frequency, setting up patients or changing modes, but as powerful as a V60. Remotely monitor and manage all of your sleep apnea and respiratory patients with a single system. * Note: Trilogy 100 and 200 ventilators were previously recalled in June 2021 due to the same foam risk. If your ventilator has an inline bacterial filter, closely monitor for PE-PUR foam pieces collecting on the filter or airflow problems. Philips Respironics has recalled certain Trilogy Evo ventilators with specific serial numbers due to potential health risks. The packing instructions are in Appendix A of the notification. 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. This Trilogy Ventilator Carrier measures 12 Wide x 13 Long x 8 High. Compared to Trilogy 100's 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. The MDRs received included both mandatory reports from Philips and voluntary reports from health professionals, consumers, and patients. All rights reserved. Trilogy Evo uses Bluetooth to send you patient and device data through Care Orchestrator, our cloud-based tool. 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. Flexibility of circuits allows it to be used in India. Digital Auto-Trak provides an automated breath triggering and cycling algorithm that adjusts to the patient's natural breathing patterns. By clicking on the link, you will be leaving the official Royal Philips ("Philips") website. 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. No duplication of any materials herein is authorized without the express consent of Apria Healthcare Group LLC. 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 URGENT Field Safety Notice is intended to inform you of the problem. Additionally, Philips observed residual PEPUR sound abatement foam in some reworked Trilogy 100 and Trilogy 200 ventilators that were returned to customers. The devices are used to help breathing. 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. Trilogy Evo Quick Start Guide for caregivers with step by step instructions. In June 2021, Philips recalled certain ventilators, BiPAP machines, and CPAP machines (see table below) because of potential health risks. Health professionals, consumers, and patients may voluntarily submit reports of device adverse events and malfunctions to the FDA. Shop for products on our online store of order seamlessly through your own procurement system. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Trilogy Evo provides noninvasive and invasive ventilator support with added sensitivity for a wide range of adult and pediatric patients. Versatile breath delivery and setup options provide greater continuity of care. Since April 2021, the FDA has received more than 98,000 MDRs, including 346 reports of death, reportedly associated with the PE-PUR foam breakdown or suspected foam breakdown. 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. Request a demo The FDA posted answers to frequently asked questions about this recall: FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls. Detachable battery charge time 0% to 80% is 2.5 hours, internal battery charge time 0% to 100% is 3.5 hours. Trilogy Evo has a four-year service interval. 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. And patients may voluntarily submit reports of device adverse events and malfunctions to the same foam risk connecting to same. Proven innovations are designed to treat the varying needs of respiratory insufficiency for caregivers with step step! 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