Inline bacterial filters may increase the resistance to air flow through the device, which could mean the ventilator will not ventilate adequately. Click here for important information about the recall of certain Philips Respironics Sleep and Respiratory Care devices. If lot number is known and is not an affected lot, no further action is required. Before sharing sensitive information, make sure you're on a federal government site. What is the Trilogy Evo Ventilator? The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 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. 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. Determine if any Trilogy Evo devices have been repaired using Trilogy Evo Muffler Assembly Part Number 1135357 starting 14 April 2021 or later. You are about to visit a Philips global content page. Trilogy Evo needs preventive maintenance only every four years, and minimal equipment for calibration. Flexibility of circuits allows it to be used in a wide range of patients. 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. Eight of those reports were from the U.S. to-use carry bag. Volume and pressure modes, AVAPS-AE, SpO2 and EtCO2 monitoring and alarms of every parameter allow for adaptable care. It's ready to be mounted onto a roll-stand or a wheelchair, with a mountable, easy- a wide range of patients. 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. No duplication of any materials herein is authorized without the express consent of Apria Healthcare Group LLC. Remotely monitor and manage all of your sleep apnea and respiratory patients with a single system. Compared to Trilogy 100's Auto Back-up Rate delays a machine breath until your patient exhales to maximize comfort. 4. Digital Auto-Trak provides an automated breath triggering and cycling algorithm that adjusts to the patient's natural breathing patterns. Volume and pressure modes, AVAPS-AE, SpO2 and EtCO2 monitoring and alarms of every parameter allow for adaptable care. Portable Oxygen Concentrators and Accessories, Sleep Diagnostics Systems Accessories and Supplies, Trilogy Evo is the only industry-leading ventilator with 15 hours of battery life with an internal and detachable battery, Every Trilogy Evo is equipped to connect with Care Orchestrator, and you can download data wirelessly or via the USB port, Trilogy Evo has a four-year service interval. This material is not intended to substitute or replace the Operating Manual or Instructions for Use. Easy access to data Mask (select one) Full Face Mask Nasal Mask Nasal Pillows RT to Fit Patient For Mask If you use one of these recalled devices, follow the recommendations listed below. Customers are instructed to: 1) Compare the serial numbers of their device(s) to Attachment A: List of . 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. 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.. Trilogy-100-Ventilator-Information-and-User-Guide. Trilogy Evo uses Bluetooth to send you patient and device data through Care Orchestrator, our cloud-based tool. 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. It is an electronically controlled, pneumatic ventilation system with an integrated air compressing system. Bacterial filters will not help to reduce exposure to certain chemicals that may be released from the PE-PUR foam. 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. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. 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. The Philips Respironics Trilogy EVO features ten ventilation modes, including: Remotely monitor and manage all of your sleep apnea and respiratory patients with a single system. The site is secure. If you have a health issue, including any of the health issues listed above, or any problem with your device, the FDA encourages you to talk to your health care provider and report the problem through the MedWatch Voluntary Reporting Form. It may be used for both invasive and non-invasive ventilation. Versatile breath delivery and setup options provide greater continuity of care. Nominal run time per method in International Electrotechnical Commission (7.5 hour/battery). Add to my planner. A/C-VC modeActivePAPcircuit, PEEP 3cmH2O andVt800ml.. By clicking on the link, you will be leaving the official Royal Philips ("Philips") website. six-hour battery, Trilogy Evo gives patients a new level of freedom and mobility. 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 mouthpiece ventilation does not require any inspiratory effort in order to trigger a breath. This solution is designed to unite the technologies, resources, people and information essential to manage your respiratory patients. 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. 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. Do not stop or change ventilator use until you have talked to your health care provider. The ventilator is suitable for use in institutional, home, and non-emergency transport settings, for example wheelchair or personal vehicle. Volume and pressure modes, AVAPS-AE, SpO2 and EtCO2 monitoring and alarms of every parameter allow for adaptable care. to-use carry bag. Koninklijke Philips N.V., 2004 - 2023. 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. 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 recall of certain Philips Respironics Sleep and Respiratory Care devices. 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. It offers new, on-screen Help and Alarm guidance and user-friendly universal names for most ventilation modes. 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 Evo uses Bluetooth to send you patient and device data through Care Orchestrator, our cloud-based tool. 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. Innovative financing solutions tailored for healthcare, providing both industry expertise and a reliable source of funds. PHILIPS RESPIRONICS RECALL: Click here for more information. Detachable battery charge time 0% to 80% is 2.5 hours, Internal batterycharge time 0% to 100% is 3.5 hours. The Philips Trilogy Evo is only portable life-support ventilator platform designed to stay with patients and provide consistent therapy and monitoring as the. Connected Trilogy provides remote viewing of key ventilation parameters, alarm data, device performance and patient usage. Trilogy Evo needs preventive maintenance only every four years, and minimal equipment for calibration. With Care Orchestrator, you have the power to create custom health rules based on your best practices and proven processes. 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. We are always interested in engaging with you. Drive collaboration among your care team with actionable patient insights delivered straight to their smart phones, tablets, or PCs. Positional therapy, such as elevating the head of your bed, using a device that prevents you from turning to your side or back, or avoiding sleeping on your back. Trilogy 200 helps care teams provide quality respiratory care while meeting patients evolving needs. 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. This update provides additional information on the recall for people who use repaired and replaced devices. It assists with ventilator to patient synchrony and comfort without manual adjustments. It delivers enhanced performance in noninvasive and invasive ventilation, so patients can be treated with a single device through . Contact us Specifications Contact us Request contact Specifications Can we help? 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. Trilogy Evo lets you smoothly transition patients through different care settings using the same clinical technologyfor continuous peace of mind. Malviya Nagar Made of Steel for substantial durability. Trilogy Evo provides noninvasive and invasive ventilator support with added sensitivity for a wide range of adult and pediatric patients. 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. UPDATE - April 13, 2023: To provide transparency for consumers who are awaiting a replacement device, the FDA is clarifying that the number of replacement and remediated devices that have been shipped to consumers in the U.S. is considerably less than the 2,460,000 number of "new replacement devices and repair kits" posted on Philips' website. a wide range of patients. The FDA's evaluation of the information provided by Philips is ongoing. All rights reserved. The Amsterdam-based medical device company began a recall in March. Philips Respironics has recalled certain Trilogy Evo ventilators with specific serial numbers due to potential health risks. With Care Orchestrator, you have the power to create custom health rules based on your best practices and proven processes. Click here for important information about the field safety notice regarding some Philips Respironics Sleep and Respiratory Care devices . Use of these devices may cause serious injuries or death. 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 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. Ltd. Proven innovations are designed to treat the varying needs of respiratory insufficiency. Trilogy-Clinical-Manual. Trilogy Evo Portable hospital-to-home ventilator, Specifications, Guidelines & User Manuals, SEND INSTRUCTIONS TO PATIENT OR CAREGIVER, Trilogy Ventilator 100 Philips Respironics Alt, Covidien Newport HT-70 Ventilator Medtronics, Instructions for Non-invasive Ventilators. 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. Ventilator-dependent patients are supported by internal and detachable batteries, now with 15-hour battery life. Trilogy Evo portable life-support ventilator. Do not stop or change patient therapy unless the patient has consulted their health care provider or unless a replacement Trilogy Evo ventilator has been provided. Compared to Trilogy 100s six-hour battery, Trilogy Evo gives patients a new level of freedom and mobility. The Ventilator can be removed from the Carrier while the main air tubing is still connected. Please navigate to the training sections most relevant to you. 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. 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. Oral appliances, which fit like a sports mouth guard or an orthodontic retainer. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. 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. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. 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. At this time, the information provided by Philips has not established that the filters can reduce the PE-PUR foam's risks. Its designed specifically with durability in mind to protect it against damage during travel, such as during medical transport. 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. 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