Class 1 Device Recall Trilogy Evo

• Date Initiated by Firm: December 22, 2021
• Date Posted: January 22, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0494-2022
• Recall Event ID: 89276
• 510(K)Number: K181170 K181166
• Product Classification: Ventilator, continuous, facility use - Product Code CBK
• Product: Trilogy Evo Repair Kit, RP-Trilogy Evo Muffler Assembly, Material Number 1135257; ; The Trilogy Evo ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg.
• Code Information: Lot Numbers 210414 - 210524
• Recalling Firm/ Manufacturer: Philips Respironics, Inc.; 1001 Murry Ridge Ln; Murrysville PA 15668-8517
• Manufacturer Reason for Recall: Philips has identified a specific lot of non-conforming material manufactured by one of its suppliers. A Philips supplier incorrectly used polyester-based polyurethane (PE-PUR) sound abatement foam, a non-conforming material in the devices and repair kits. PE-PUR foam may degrade into particles which may enter the device s air pathway and be ingested or inhaled by the user. The foam degradation may be exacerbated by use of unapproved cleaning methods such as unapproved ozone cleaners, and the PE-PUR foam may off-gas certain chemicals during initial use of the device.
• FDA Determined Cause: Mixed-up of materials/components
• Action: Affected customers were contacted via telephone or web meeting on or around 12/22/21. URGENT Medical Device Recall notification letters were distributed to customers beginning 12/22/21. Trilogy Evo: Actions that should be taken by the customer/user in order to prevent risks for patients or users: a. Create awareness of this safety information by forwarding to your organization s personnel. b. Identify all of the impacted devices purchased by your organization. c. 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. d. Instruct patients and/or caregivers to closely monitor the bacteria filter for foam debris. Additionally, instruct patients and/or caregivers to be aware of potential changes in breathing circuit resistance after filter placement. e. Inspect and clean the patient circuit and accessories per the instructions included with this communication. f. A replacement Trilogy Evo ventilator will be provided by Philips. Once the patient has been transitioned, return the affected Trilogy Evo ventilator to Philips. Your Philips Representative will provide a return authorization and any support needed to facilitate this return. See packing instructions in Appendix A. The actions planned by Philips Respironics to correct the problem: Philips is contacting all customers that have purchased affected ventilators. Philips will send a new Trilogy Evo unit to replace affected devices. Customers should return affected units within 90 days of receiving a replacement unit. Philips has implemented more rigorous supplier controls to prevent this issue from happening again. If you need any additional information or support concerning this issue, please contact your Philips representative. If any of the following accessories that come in contact with the air pathway are being re-used from an affected device, visually inspect for evidence of black foam particles before
• Quantity in Commerce: 205 kits
• Distribution: Worldwide Distribution: Distributed to the following US states: AR, CO, FL, IA, IL, KY, LA, MI, MT, OH, PA, TN, TX, UT, VA, WV, and WY; and Distributed to the following foreign countries: Argentina, Brazil, Romania, and Netherlands.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = CBK and Original Applicant = Respironics Inc.