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Philips recalls additional Trilogy vents

Philips recalls additional Trilogy vents Trilogy 100 and 200 vents were previously recalled in June 2021

WASHINGTON – Philips Respironics has recalled certain Trilogy Evo ventilators for potential health risks from PE-PUR foam, according to the U.S. Food and Drug Administration. 

The recall affects 215 Trilogy Evo Ventilators (DS211OX11B) and 51 repair kits (KR211X15B, not distributed in the United States). 

“A Philips supplier incorrectly used polyester-based polyurethane (PE-PUR) sound abatement foam, a non-conforming material, in the muffler assembly of the affected Trilogy Evo ventilators,” the FDA states “The issue was identified during lab testing of the Trilogy Evo ventilator. The Trilogy Evo ventilators with non-conforming foam were distributed to customers in the United States and Korea. There have been no reported injuries or death to date.” 

The FDA noted that Trilogy 100 and 200 ventilators were previously recalled in June 2021 due to the same foam risk. 

Philips Respironics sent an Urgent Medical Device Recall notification to Trilogy Evo ventilator customers on Dec. 21, 2021, and the company sent an updated version to clarify information on cleaning and filters on Jan. 13, 2022. 

The notification requested customers take the following actions: 

  • Create awareness of this safety information by forwarding to your organization's personnel. 
  • Identify all of the impacted devices purchased by your organization. 
  • 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. 
  • Instruct patients and/or caregivers to closely monitor the bacteria filter for foam debris. Using an inline bacterial filter may help to filter out particles of foam. Additionally, after placement of an inline filter, instruct patients and/or caregivers to be aware of potential changes in breathing circuit resistance and monitor as ventilator performance may change due to increase in resistance of air flow through the device after filter placement. Bacterial filters will not help to reduce exposure to certain chemicals that may be released from the PE-PUR foam. 
  • Inspect and clean the patient circuit and accessories per the instructions included with the notification. 
  • 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. The packing instructions are in Appendix A of the notification. 

For the repair kit for Trilogy Evo muffler assembly, the Dec. 21, 2021, notification letter requested customers take the following actions: 

  • Segregate inventory of Repair Kit - Trilogy Evo Muffler Assembly Part Number 1135257, and quarantine any lot between 210414 and 210524. 
  • Do not use any quarantined material and contact Philips for return instructions. You will be shipped replacements. 
  • Determine if any Trilogy Evo devices have been repaired using Trilogy Evo Muffler Assembly Part Number 1135357 starting 14 April 2021 or later 
  • If the lot number used in repair is between 210414 and 210524. Contact Philips for next steps. Philips will replace the device these parts were installed into. 
  • If the lot number used in a repair is unknown, assume it is affected and contact Philips for next steps. Philips will replace the device these parts were installed into. 
  • If lot number is known and is not an affected lot, no further action is required. 

Certain other Trilogy models are not affected by this most recent recall: Trilogy Evo O2, Trilogy EV300 and Trilogy Evo Universal.   


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