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 is designed for easy navigation and fast set-up of prescriptions. This material is not intended to substitute or replace the Operating Manual or Instructions for Use. A replacement Trilogy Evo ventilator will be provided by Philips. six-hour battery, Trilogy Evo gives patients a new level of freedom and mobility. This is a 10-pack of particulate filters for use with the Trilogy Evo and Trilogy EV300 ventilators. 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. Your Philips Representative will provide a return authorization and any support needed to facilitate this return. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. Copyright 2023 Apria Healthcare Group LLC. Trilogy Evo has a four-year service interval. Auto Back-up Rate delays a machine breath until your patient exhales to maximize comfort. In addition to usage rates, other Connected Trilogy Health Rules can be set for gross change and absolute threshold settings including: Auto Back-up Rate delays a machine breath until your patient exhales to maximize comfort. It's designed specifically with durability in mind to protect it against damage during travel, such as during medical transport. 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. 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.. Flexibility of circuits allows it to be used in The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. This solution is designed to unite the technologies, resources, people and information essential to manage your respiratory patients. The company formally submitted their Report of Correction and Removal (a report under 21 CFR part 806, or "806 report") in June 2021. Volume and pressure modes, AVAPS-AE, SpO2 and EtCO2 monitoring and alarms of every parameter allow for adaptable care. If you have additional concerns, talk to your health care provider about the plan for your care and treatment. One can have full access to all of the control buttons. 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. Trilogy Evo is the only industry-leading ventilator with 15 hours of battery life with an internal and detachable battery. Health professionals, consumers, and patients may voluntarily submit reports of device adverse events and malfunctions to the FDA. Instructions include video demonstrations and user manuals for respiratory therapy Read more For privacy reasons YouTube needs your permission to be loaded. Run your business as you see fit, customizing reports and alerts to aid in identifying patients at risk and provide them with timely care. 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. The polyester-based polyurethane (PE-PUR) foam used in these devices to reduce sound and vibration can break down. Break down (degrade) into black pieces that may enter the device's air tubes and be inhaled or swallowed by the user. Trilogy Evo provides noninvasive and invasive ventilator support with added sensitivity for a wide range of adult and pediatric patients. to-use carry bag. Trilogy Evo is versatile enough that it allows for use across multiple care settings and easy transitions. Flexibility of circuits allows it to be used in 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). 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. Detachable battery charge time 0% to 80% is 2.5 hours, Internal batterycharge time 0% to 100% is 3.5 hours. Code Information. 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. 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. Trilogy Evo uses Bluetooth to send you patient and device data through Care Orchestrator, our cloud-based tool. 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's ready to be mounted onto a roll-stand or a wheelchair, with a mountable, easy- 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. 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. Request a demo 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. 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. Shop for products on our online store of order seamlessly through your own procurement system. Strategic Partnerships and Healthcare Solutions. The Philips Respironics Trilogy 202 is both a volume-control & pressure-control ventilator for invasive and non-invasive ventilation. 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. eLearning. Trilogy Evo is designed for easy navigation and fast set-up of prescriptions. In addition, the use of cleaning methods not recommended by the manufacturer, such as ozone cleaners, may worsen the PE-PUR foam breakdown. Do not use any quarantined material and contact Philips for return instructions. It is an electronically controlled, pneumatic ventilation system with an integrated air compressing system. Philips will replace the device these parts were installed into. Please note, these devices can continue to be safely 110017, New Delhi 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. Malviya Nagar Once the patient has been transitioned, return the affected Trilogy Evo ventilator to Philips. The Philips Trilogy Evo is only portable life-support ventilator platform designed to stay with patients and provide consistent therapy and monitoring as the. It is compatible with a range of accessories to provide a variety of therapy modes. Volume and pressure modes, AVAPS-AE, SpO2 and EtCO2 monitoring and alarms of every parameter allow for adaptable care. Volume and pressure modes, AVAPS-AE, SpO2 and EtCO2 monitoring and alarms of every parameter allow for adaptable care. Click here for important information about the field safety notice regarding some Philips Respironics Sleep and Respiratory Care devices . The FDA has reached this determination based on an overall benefit-risk assessment. There have been no reported injuries or death to date. The PE-PUR foam used in the recalled devices may break down and can result in serious injury, cause permanent impairment, and require medical intervention to prevent permanent injury to users. We are always interested in engaging with you. 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. You can also download data at the point of care through a USB drive. Because of these limitations, MDRs comprise only one of the FDA's several important postmarket surveillance data sources. 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. The newest Trilogy device was made to be user-friendly without compromising the advanced features of the innovative Trilogy family technology. The mouthpiece ventilation does not require any inspiratory effort in order to trigger a breath. Compared to Trilogy 100s six-hour battery, Trilogy Evo gives patients a new level of freedom and mobility. 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. Digital Auto-Trak provides an automated breath triggering and cycling algorithm that adjusts to the patients natural breathing patterns. The mouthpiece ventilation does not require any inspiratory effort in order to trigger a breath. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. This interactive module will provide you will an overview of the Trilogy Evo ventilator including how to initiate ventilation and navigate through the windows. Add to my planner. Available with Trilogy Evo O2 only 2. 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. From hospital to home or clinicians to caregivers, transitions in respiratory care can be challenging. Auto Back-up Rate delays a machine breath until your patient exhales to maximize comfort. Flexibility of circuits allows it to be used in a wide range of patients. a wide range of patients. With BARDA's continuing support, Philips finally won FDA approval for the Trilogy Evo Universal ventilator in July 2019. Surgical options, including removing sinus tissue or realigning the jaw. 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. Trilogy Evo provides noninvasive and invasive ventilator support with added sensitivity for a wide range of adult and pediatric patients. 2022-23 Medinfra India. 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). Increase your teams efficiencies and streamline your workflow for a sharper focus on higher clinical priorities. 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. 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. *Nominal run time per method in International Electrotechnical Commission (7.5 hour/battery). Meet your patients changing needsTrilogy Evo provides noninvasive and invasive ventilator support with added sensitivity for a wide range of adult and pediatric patients. Contact Philips for next steps. Easy access to data Detachable battery charge time 0% to 80% is 2.5 hours, internal battery charge time 0% to 100% is 3.5 hours. Proven innovations are designed to treat the varying needs of respiratory insufficiency. Trilogy Evo portable life-support ventilator. 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. Trilogy Evo uses Bluetooth to send you patient and device data through Care Orchestrator, our cloud-based tool. You are about to visit a Philips global content page. 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 InternationalElectrotechnicalCommission (7.5 hr/battery). Run your business as you see fit, customizing reports and alerts to aid in identifying patients at risk and provide them with timely care. It assists with ventilator to patient synchrony and comfort without manual adjustments. 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. 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. Koninklijke Philips N.V., 2004 - 2023. Trilogy Evo needs preventive maintenance only every four years, and minimal equipment for calibration. Compared to Trilogy 100's Manufacturers, such as Philips, are required to submit medical device reports (MDRs) when they become aware of an event that reasonably suggests that one of their devices may have caused or contributed to a death or serious injury, or has malfunctioned and that device or a similar device marketed by the manufacturer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. 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. Proven PerformancePhilips Respironics Trilogy EVO (OBM) Portable 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. Ventilator-dependent patients are supported by internal and detachable batteries, now with 15-hour battery life. Award-winning service delivered in ways that promote your clinical, operational and technical success. Comprehensive, clinically relevant courses to help enhance operational efficiency and provide high-quality patient care. More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov. Koninklijke Philips N.V., 2004 - 2023. Trilogy Evo needs preventive maintenance only every four years, and minimal equipment for calibration. 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