Identify all of the impacted devices purchased by your organization. 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. 4. Your Philips Representative will provide a return authorization and any support needed to facilitate this return. Turn the Trilogy nebulizer feature to "on" 3. The newest Trilogy device was made to be user-friendly without compromising the advanced features of the innovative Trilogy family technology. Before sharing sensitive information, make sure you're on a federal government site. 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. Follow Philips' instructions for recommended cleaning of your CPAP machine and accessories. 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. It offers new, on-screen Help and Alarm guidance and user-friendly universal names for most ventilation modes. Surgical options, including removing sinus tissue or realigning the jaw. 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. Versatile breath delivery and setup options provide greater continuity of care. The FDA is aware that patients have already received devices with silicone-based foam as part of the repair and replace program. The Philips Trilogy Evo is only portable life-support ventilator platform designed to stay with patients and provide consistent therapy and monitoring as the. Koninklijke Philips N.V., 2004 - 2023. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. Trilogy Evo portable life-support ventilator From hospital to home or clinicians to caregivers, transitions in respiratory care can be challenging. 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. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. 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. This Trilogy Ventilator Carrier measures 12 Wide x 13 Long x 8 High. Enable consistent and high-quality invasive and noninvasive ventilation . Although MDRs are a valuable source of information, this passive surveillance system has limitations. Compared to Trilogy 100's Philips will replace the device these parts were installed into. 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. Increase your teams efficiencies and streamline your workflow for a sharper focus on higher clinical priorities. You can also download data at the point of care through a USB drive. Bacterial filters will not help to reduce exposure to certain chemicals that may be released from the PE-PUR foam. Drive collaboration among your care team with actionable patient insights delivered straight to their smart phones, tablets, or PCs. Inline bacterial filters may increase the resistance to air flow through the device, which could mean the ventilator will not ventilate adequately. Run your business as you see fit, customizing reports and alerts to aid in identifying patients at risk and provide them with timely care. 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 pediatric patients. Contact us Specifications Contact us Request contact Specifications Can we help? The Philips Respironics Trilogy EVO features ten ventilation modes, including: 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. *Nominal run time per method in International Electrotechnical Commission (7.5 hour/battery). You are about to visit a Philips global content page. Trilogy Evo provides noninvasive and invasive ventilator support with added sensitivity for a wide range of adult and pediatric patients. Easy access to data 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. 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. Ventilator-dependent patients are supported by internal and detachable batteries, now with 15-hour battery life. If the lot number used in repair is between 210414 and 210524. Invasive/noninvasive ventilation for patients 5kg and above, Auto-adaptive technology can help patient synchrony and therapy acceptance, Up to six hours* of battery life supports portability, Bluetooth connectivity options along with optional SpO2 monitoring, Single limb (Passive, Active PAP, Active Flow). The Philips Respironics Trilogy 202 is both a volume-control & pressure-control ventilator for invasive and non-invasive ventilation. 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. * Note: Trilogy 100 and 200 ventilators were previously recalled in June 2021 due to the same foam risk. Trilogy Evo uses Bluetooth to send you patient and device data through Care Orchestrator, our cloud-based tool. Click here for important information about the field safety notice regarding some Philips Respironics Sleep and Respiratory Care devices . Volume and pressure modes, AVAPS-AE, SpO2 and EtCO2 monitoring and alarms of every parameter allow for adaptable care. This solution is designed to unite the technologies, resources, people and information essential to manage your respiratory patients. 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. Customers are instructed to: 1) Compare the serial numbers of their device(s) to Attachment A: List of . This module will provide you with some basics on how to use your Trilogy Evo ventilator. Trilogy Evo provides noninvasive and invasive ventilator support with added sensitivity for a wide range of adult and pediatric patients. There is no required component replacement, and can be . All Rights Reserved. The newest Trilogy device was made to be user-friendly without compromising the advanced features of the innovative Trilogy family technology. Once the patient has been transitioned, return the affected Trilogy Evo ventilator to Philips. You may or may not see black pieces of the foam in the air tubes or masks. 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. The company formally submitted their Report of Correction and Removal (a report under 21 CFR part 806, or "806 report") in June 2021. Trilogy Evo provides noninvasive and invasive ventilator support with added sensitivity for a wide range of adult and pediatric patients. It assists with ventilator to patient synchrony and comfort without manual adjustments. a wide range of patients. 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. Compared to Trilogy 100s six-hour battery, Trilogy Evo gives patients a new level of freedom and mobility. data fl ow, Trilogy Evo helps benefi t a broad spectrum of patients, from newborns to adults. Using an inline bacterial filter may help to filter out particles of foam. - Used these ventilators/devices: Esprit, VOCSN, and Avea ventilators, Airvo high flow nasal cannulas, Respironics V60 BiPAPs, and oxygen blenders . Trilogy-100-Ventilator-Information-and-User-Guide. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. 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. Health professionals, consumers, and patients may voluntarily submit reports of device adverse events and malfunctions to the FDA. Trilogy Evo ventilators deliver enhanced performance in both non-invasive (NIV) and invasive ventilation. 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. Remotely monitor and manage all of your sleep apnea and respiratory patients with a single system. 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. The FDA's evaluation of the information provided by Philips is ongoing. Koninklijke Philips N.V., 2004 - 2023. Use another similar device that is not a part of this recall. Flexibility of circuits allows it to be used in a wide range of patients. 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. 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 ventilation. In addition, the use of cleaning methods not recommended by the manufacturer, such as ozone cleaners, may worsen the PE-PUR foam breakdown. 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. 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. We are always interested in engaging with you. 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