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.
Enforcement
- Recall Number
- Z-0494-2022
- Event ID
- 89276
- Classification
- Class I
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Philips Respironics, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 2, 2022
- Initiation Date
- December 22, 2021
- Classification Date
- January 21, 2022
- Address
- 1001 Murry Ridge Ln, Murrysville, PA, 15668-8517, United States
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.
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.
Lot Numbers 210414 - 210524
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.
205 kits