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Certain Reworked Philips Respironics Trilogy 100/200 Ventilators Recalled Due to Potential for Silicone Foam Adhesion Failure and Residual PE‐PUR Foam Debris

Today, the U.S. Food and Drug Administration (FDA) issued a safety communication to provide additional information to patients, caregivers, and health care providers about two recent issues in certain reworked Philips Respironics (Philips) Trilogy 100 and Trilogy 200 ventilators. These Philips Trilogy 100 and Trilogy 2000 ventilators were recalled in June 2021 for issues with the polyester-based polyurethane (PE-PUR) sound abatement foam breakdown. The two recent issues are:

• The replacement silicone sound abatement foam, installed to replace the PE-PUR foam, may separate from the plastic backing due to adhesive failure. The silicone foam material may move and potentially block the airpath.
• Additionally, Philips observed residual PE‐PUR sound abatement foam in some reworked Trilogy 100 and Trilogy 200 ventilators that were returned to customers. Further exposure to PE-PUR foam can result in serious injury, cause permanent impairment, and require medical intervention to prevent permanent injury to users.

This safety communication provides:

• Background information about the issue and device.
• Recommendations for patients, caregivers, and health care providers.
• Information about the FDA’s actions.
• Instructions for reporting problems with the Trilogy ventilators to the FDA.

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Questions?

• If you need any further information or support about this issue, please contact your local Philips representative or Philips Customer Service at 1-800-345-6443 or visit Philips Information for Patients.
• If you have questions about this safety communication, contact the Division of Industry and Consumer Education (DICE).
• The FDA.gov website includes FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls to address questions about the recalls and provides additional resources with more information on the June 2021 recall.