Field Safety Notice Trilogy Evo, Trilogy Evo 02, Trilogy EV300 Flow Sensor Nebulised Aerosol Deposition (ICN 2686)

MHRA TBC

NHSSC Ref: 50

• Philips Respironics has issued an update to the Field Safety Notice, 2024-CC-SRC-013, regarding Trilogy Evo, Trilogy Evo O2, Trilogy EV300, Flow Sensor Nebulized Aerosol Deposition previously communicated in September 2024.
• The previous September 2024 communication was intended to provide information on the issue as well as guidance for proper placement of the in-line nebulizer.
• This update is intended to provide further guidance for customers to determine what immediate actions and service requirements are necessary for your devices.
• Please follow the added guidance provided within Appendix B, page eight of the notice, in addition to the guidance provided in the previously communicated FSN, which is repeated in this notice for convenience.
• Complete and sign the reply form, page six of the Field Safety Notice, and return to: safetynoticeuki@philips.com.

MHRA TBC

NHSSC Ref: 50

Alert:

• Philips Respironics has issued an urgent Field Safety Notice having become aware of a potential issue when using in-line nebulizers in certain configurations with Trilogy Evo, Trilogy Evo O2, and Trilogy EV300 devices. The use of in-line nebulizers placed in certain locations can result in aerosol deposits accumulating over time on the device’s internal flow sensor.
• Impacted flow sensors may result in inaccurate flow measurements in circumstances outlined in the Field Safety Notice.
• Philips Respironics advise they have not received any specific complaints of device malfunctions resulting from in-line nebulizer use but have performed a retrospective complaint review from product launch through to 31 July 2024 and identified 928 complaints that, based on the symptoms reported in the complaint, may indicate the flow sensors were not performing as expected. Three (3) reports included allegations of serious injury. This is a reported incidence rate of less than 0.001%. No deaths have been reported.

Products Affected:

•  One of the products affected is available from NHS Supply Chain:

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Any Trilogy Evo, Trilogy Evo O2, and Trilogy EV300 devices that have historically been used with an in-line nebulizer in certain configurations may be impacted.
• If your device has never been used with an in-line nebulizer, it is not affected by this issue and can continue to be used.
• If using an in-line nebulizer, continue to use in accordance with the guidance in the Field Safety Notice.
• Complete and sign the reply form page 6 of the Field Safety Notice and return to: safetynoticeuki@philips.com
• Philips Respironics advise this communication is intended to provide awareness and understanding of the issue and immediate actions to be taken by the customer when using an in-line nebulizer.
• Philips Respironics understands that use of in-line nebulizers is common amongst ventilator patients and is working diligently to further understand the interaction between in-line nebulizers and the flow sensor within the Trilogy Evo devices.
• Philips Respironics confirm they are continuing to investigate this issue and will follow-up with customers to provide additional guidance and solutions as it becomes available during the next few months.

If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor or the Hospital Care team.

Please be aware that in the event of a Field Safety Notice/Product Recall we may need to provide manufacturers, UK responsible Persons and Distributers with contact details of customers who have potentially received the affected stock. This is to help them to reconcile their stock and evidence to the regulators that all actions have been taken to ensure that the unused products have been removed from customers to prevent inadvertent use of faulty and potentially unsafe products.