Trilogy Evo Repair Kit, RP-Trilogy Evo Muffler Assembly, Material Number 1135257 The Trilogy Evo ventilator provides con

FDA device recall Z-0494-2022 · posted 2022-01-22 · Open, Classified

Recall details

Recalling firm

Philips Respironics, Inc.

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.

Action taken

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

Root cause

Mixed-up of materials/components

Status

Open, Classified

Product code

CBK

Quantity affected

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, B

Date initiated

2021-12-22

Date posted

2022-01-22

Location

Murrysville, PA

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