Recall Z-0494-2022 ยท CBK Ventilator, Continuous, Facility Use
Philips Respironics, Inc.
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.
| Date | Jan 22, 2022 (initiated Dec 22, 2021) |
| Status | Open, Classified |
| Reason | 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. |
| Root 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 |
| Quantity | 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. |
| FDA record | Open on fda.gov |