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. The Ventilator can be removed from the Carrier while the main air tubing is still connected. 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). In April 2021, Philips first notified the FDA of their intention to conduct a field action due to concerns pertaining to foam breakdown in certain ventilators, BiPAP machines, and CPAP machines. to-use carry bag. 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. Emergency Care and Resuscitation Solutions, Radiography | X-ray & Fluoroscopy Solutions, Transition to the future of respiratory care with, For more information on our Philips Learning connection please click here. It's ready to be mounted onto a roll-stand or a wheelchair, with a mountable, easy- It's designed specifically with durability in mind to protect it against damage during travel, such as during medical transport. If lot number is known and is not an affected lot, no further action is required. Your Philips Representative will provide a return authorization and any support needed to facilitate this return. 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 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. Strategic Partnerships and Healthcare Solutions. Auto Back-up Rate delays a machine breath until your patient exhales to maximize comfort. The issue was identified during lab testing of the Trilogy Evo ventilator. Its ready to be mounted onto a roll-stand or a wheelchair, with a mountable, easy- to-use carry bag. 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 ventilators deliver enhanced performance in both non-invasive (NIV) and invasive ventilation. The newest Trilogy device was made to be user-friendly without compromising the advanced features of the innovative Trilogy family technology. 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. 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. 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. The ventilator can measure, display, record, and alarm oxygen saturation level (SpO2), fraction of inspired oxygen (FiO2), carbon dioxide (CO2) and pulse rate data when integrated with the appropriate accessories. The newest Trilogy device was made to be user-friendly without compromising the advanced features of the innovative Trilogy family technology. Its designed specifically with durability in mind to protect it against damage during travel, such as during medical transport. CPAP Full Face Masks. Connected Trilogy provides remote viewing of key ventilation parameters, alarm data, device performance and patient usage. Add to my planner. Change filter (may be blocked with powder, smoke, dust, etc.) They are generally used on patients who have higher pressures that can't be tolerated with a nasal mask, or patients who do not want to wear a chin strap to help keep the mouth from coming open during the night to prevent loss of PAP pressure, or for . Trilogy-Clinical-Manual. Trilogy Evo portable life-support ventilator. 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. Easy access to data 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. Comprehensive, clinically relevant courses to help enhance operational efficiency and provide high-quality patient care. The Amsterdam-based medical device company began a recall in March. 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. Flexibility of circuits allows it to be used in a wide range of patients. 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. Trilogy Evo: Our new, portable life-support ventilator platform designed to: Deliver maximum portability to patients with 15 hours of battery life, easily mounting on wheelchairs, and a convenient carrying bag that lets you see the screen and alarms, Connect to CareOrchestrator enabling you to track and assess patientsventilation data fromvirtually anywhere, Provide a longerlifespan (10 years). Please note, these devices can continue to be safely Customers in the U.S. with questions about this recall should contact Philips Respironics at 1-800-722-9377 or email Respironics.repair@philips.com. 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. Eight of those reports were from the U.S. Break down (degrade) into black pieces that may enter the device's air tubes and be inhaled or swallowed by the user. Flexibility of circuits allows it to be used in a wide range of patients. Quick links to help you find what you need or see how to get in touch with a customer service representative. Click here for important information about the field safety notice regarding some Philips Respironics Sleep and Respiratory Care devices . Run your business as you see fit, customizing reports and alerts to aid in identifying patients at risk and provide them with timely care. Ventilator-dependent patients are supported by internal and detachable batteries, now with 15-hour battery life. You can also download data at the point of care through a USB drive. Do not use any quarantined material and contact Philips for return instructions. Proven innovations are designed to treat the varying needs of respiratory insufficiency. All rights reserved. Compared to Trilogy 100's We are always interested in engaging with you. When the PE-PUR foam breaks down, it may: The potential risks of particulate exposure if inhaling or swallowing pieces of PE-PUR foam include: The potential risks of inhaling chemicals released into the device's air tubes from the PE-PUR foam include: During the 2021 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 VOCs. The mouthpiece ventilation does not require any inspiratory effort in order to trigger a breath. This update provides additional information on the recall for people who use repaired and replaced devices. * Note: Trilogy 100 and 200 ventilators were previously recalled in June 2021 due to the same foam risk. a wide range of patients. Made of Steel for substantial durability. 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. You are about to visit a Philips global content page. Follow Philips' instructions for recommended cleaning of your CPAP machine and accessories. Available with Trilogy Evo O2 only 2. The FDA has reached this determination based on an overall benefit-risk assessment. It assists with ventilator to patient synchrony and comfort without manual adjustments. Code Information. This interactive module will provide you will an overview of the Trilogy Evo ventilator including how to initiate ventilation and navigate through the windows. If you have additional concerns, talk to your health care provider about the plan for your care and treatment. 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. By clicking on the link, you will be leaving the official Royal Philips ("Philips") website. 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. 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". 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. 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