*Nominal run time per method in International Electrotechnical Commission (7.5 hour/battery). Printing and scanning is no longer the best way to manage documents. 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. Its designed specifically with durability in mind to protect it against damage during travel, such as during medical transport. It assists with ventilator to patient synchrony and comfort without manual adjustments. Trilogy Evo, Material Numbers DS2110X11B (USA) and KR2110X15B (Korea) The Trilogy Evo ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. One can have full access to all of the control buttons. All Rights Reserved. Koninklijke Philips N.V., 2004 - 2023. Trilogy Evo lets you smoothly transition patients through different care settings using the same clinical technologyfor continuous peace of mind. 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. With BARDA's continuing support, Philips finally won FDA approval for the Trilogy Evo Universal ventilator in July 2019. This is a 10-pack of particulate filters for use with the Trilogy Evo and Trilogy EV300 ventilators. Philips EverFlo Oxygen Concentrator 5 Ltr, Philips Respironics Trilogy EVO (OBM) Ventilator, Fresenius Kabi Syringe and Infusion Pumps, Check Out Philips Everflo Oxygen Concentrator, 35 2000 ml on Dual Limb and Active Flow circuits, 50 2000 ml on passive and active PAP circuits, 0 35 cmH20 for active circuits 3 25 cmH20 for passive circuits, Off, AutoTrak, Sensitive, AutoTrak, and Flow Trigger, Synchronized intermittent mandatory ventilation (volume control), Mouthpiece ventilation (pressure control), Synchronized intermittent mandatory ventilation (pressure control), 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, 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. The Philips Respironics Trilogy EVO features ten ventilation modes, including: This interactive module will provide you will an overview of the Trilogy Evo ventilator including how to initiate ventilation and navigate through the windows. 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. Philips will replace the device these parts were installed into. 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. Trilogy Evo portable life-support ventilator 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. 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. Versatile breath delivery and setup options provide greater continuity of care. 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. Volume and pressure modes, AVAPS-AE, SpO2 and EtCO2 monitoring and alarms of every parameter allow for adaptable care. Proven innovations are designed to treat the varying needs of respiratory insufficiency. 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). Compared to Trilogy 100's Introducing Trilogy Evo: Our new, portable life-support ventilator platform designed to: Stay with patients across care settings. 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. 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. Handy tips for filling out Trilogy100 Ventilator online. 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. By clicking on the link, you will be leaving the official Royal Philips ("Philips") website. - Used this ventilator: Trilogy EVO Enable consistent and high-quality invasive and noninvasive ventilation . The breakdown of the PE-PUR foam may result from exposure to hot and humid conditions. 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. It offers new, on-screen Help and Alarm guidance and user-friendly universal names for most ventilation modes. 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. 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. Ltd. It's designed specifically with durability in mind to protect it against damage during travel, such as during medical transport. The PE-PUR foam issue may result from exposure to hot and humid conditions and may be exacerbated by the use of ozone cleaners or other cleaning methods not recommended by the manufacturer. "Connect with Philips Online: - Visit Philips Sleep and Respiratory Care Website: www.philips.com/healthcare/solutions/sleep-and-respiratory-care- Find Phili. 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. 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. By clicking on the link, you will be leaving the official Royal Philips ("Philips") website. It offers new, on-screen Help and Alarm guidance and user-friendly universal names for most ventilation modes. Flexibility of circuits allows it to be used in Volume and pressure modes, AVAPS-AE, SpO2 and EtCO2 monitoring and alarms of every parameter allow for adaptable care. We are always interested in engaging with you. Nominal run time per method in InternationalElectrotechnicalCommission (7.5 hr/battery). Volume and pressure modes, AVAPS-AE, SpO2 and EtCO2 monitoring and alarms of every parameter allow for adaptable care. 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). 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. Versus Trilogy 100 and 200, 1. data fl ow, Trilogy Evo helps benefi t a broad spectrum of patients, from newborns to adults. The FDA's evaluation of the information provided by Philips is ongoing. Trilogy Evo provides noninvasive and invasive ventilator support with added sensitivity for a wide range of adult and pediatric patients. Detachable battery charge time 0% to 80% is 2.5 hours, internal battery charge time 0% to 100% is 3.5 hours. 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. Meet your patients changing needsTrilogy Evo provides noninvasive and invasive ventilator support with added sensitivity for a wide range of adult and pediatric patients. 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. Connected Trilogy Health Rules can be customized with patient-specific ventilator parameters to trigger notifications that proactively identify patients with potential increased need for intervention. Flexibility of circuits allows it to be used in a wide range of patients. The devices are used to help breathing. A/C-VC modeActivePAPcircuit, PEEP 3cmH2O andVt800ml. 2. The Trilogy Evo is a portable hospital-to-home ventilator that is intuitive, easy to use, features a long-lasting battery and more! The mouthpiece ventilation does not require any inspiratory effort in order to trigger a breath. 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". SpO2, EtCO2 and advanced respiratory mechanics monitoring capabilities are designed to help you optimize your patients therapy. Trilogy Evo is designed for easy navigation and fast set-up of prescriptions. It's designed specifically with durability in mind to protect it against damage during travel, such as during medical transport. The polyester-based polyurethane (PE-PUR) foam used in these devices to reduce sound and vibration can break down. Copyright 2023 Apria Healthcare Group LLC. Proven innovations are designed to treat the varying needs of respiratory insufficiency. Determine if any Trilogy Evo devices have been repaired using Trilogy Evo Muffler Assembly Part Number 1135357 starting 14 April 2021 or later. A complete list of affected devices is available in the Medical Device Recalls database. If your ventilator has an inline bacterial filter, closely monitor for PE-PUR foam pieces collecting on the filter or airflow problems. 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. Made of Steel for substantial durability. 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. Follow the recommendations above for the recalled devices used in health care settings. This module will provide you with some basics on how to use your Trilogy Evo ventilator. There is no required component replacement, and can be serviced with standard service tools. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. An online platform to manage and service your Philips products and related services across modalities - all at no additional cost. Easy access to data Code Information. 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. Use of these devices may cause serious injuries or death. The filters protect patients from impurities in the air, the ventilator from corrosion, and healthcare professionals from exhaled pathogens and medication remnants. Ventilator-dependent patients are supported by internal and detachable batteries, now with 15-hour battery life. Connected Trilogy provides remote viewing of key ventilation parameters, alarm data, device performance and patient usage. 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. These issues could potentially result in serious injury and require medical intervention to prevent permanent injury. Easy access to data Trilogy Evo Trilogy Evo O2 Trilogy 100 Trilogy 200 Philips Hospital/Home Ventilation Solutions 1. You are about to visit a Philips global content page. If you use one of these recalled devices, follow the recommendations listed below. 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. The Philips Respironics Trilogy 202 is both a volume-control & pressure-control ventilator for invasive and non-invasive ventilation. 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. 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. Trilogy Evo uses Bluetooth to send you patient and device data through Care Orchestrator, our cloud-based tool. Disclaimers 1. Increase your teams efficiencies and streamline your workflow for a sharper focus on higher clinical priorities. It's ready to be mounted onto a roll-stand or a wheelchair, with a mountable, easy- 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. Quick links to help you find what you need or see how to get in touch with a customer service representative. Ventilator-dependent patients are supported by internal and detachable batteries, now with 15-hour battery life. Contact us Specifications Contact us Request contact Specifications Can we help? You can also download data at the point of care through a USB drive. 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. CPAP Full Face Masks. 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