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Trilogy Evo Repair Kit, RP-Trilogy Evo Muffler Assembly… recallZ-0494-2022 · Philips Respironics, Inc. · initiated Dec 22, 2021

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Philips Respironics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Mixed-up of materials/components

What the company is doing

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

Recall details

Recall number
Z-0494-2022
Status
Open, Classified
Initiated by the company
Dec 22, 2021
Posted by the FDA
Jan 22, 2022
Recalling firm
Philips Respironics, Inc.
Quantity
205 kits
Product code
CBK
FDA submissions
K181166, K181170
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.

Product description

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 (models, lots, serial numbers)

Lot Numbers 210414 - 210524

Other devices under the same FDA submission

1 device cleared under K181166, K181170 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 89276).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page