Philips Respironics Issues Additional Usage Instructions for Trilogy Evo Ventilators Related to Use of In-Line Nebulizers

Philips Respironics Issues Additional Usage Instructions for Trilogy Evo Ventilators Related to Use of In-Line Nebulizers

Company Announcement

• Additional Usage Instructions issued by Philips as voluntary correction (Urgent Medical Device Correction in the US, Field Safety Notice outside of the US)
• Additional Usage Instructions provide user action and guidance for continued use of affected devices
• Philips Respironics has not received any specific complaints of device malfunctions resulting from in-line nebulizer use; issue identified by retrospective review of flow sensor performance

Philips Respironics

Philips Respironics issued a voluntary correction for Trilogy Evo, Trilogy Evo O2, Trilogy Evo Universal, and Trilogy EV300 ventilators regarding the use of in-line nebulizers.

An Urgent Medical Device Correction (Field Safety Notice in the rest of world) is being sent to health systems and equipment distributors and is being communicated through this additional update to ensure patients who use the devices at home are informed in a timely manner.

Patients will receive communication from their usual health provider and should not discontinue therapy without consulting their healthcare provider. This update, and the associated Urgent Medical Device Correction (Field Safety Notice in the rest of world) provides instructions for user action and guidance for continued use of affected devices. Philips Respironics is investigating a solution and will provide additional information when available.

Philips Respironics has not received any specific complaints of device malfunctions resulting from in-line nebulizer use. As part of ongoing quality management, the company performed a retrospective review and identified a potential issue with flow sensors. At the time of this notification, no patient deaths have been reported.

An in-line nebulizer is a commonly-used accessory that converts therapeutic liquids (such as medication/saline solutions) into an aerosol to treat different respiratory symptoms.

Philips Respironics has determined that in some circumstances, the use of in-line nebulizers placed in certain locations may lead to aerosol deposits forming over time on the ventilator flow sensor. Should this occur, there is a possibility of inaccurate flow measurements affecting therapy.

Trilogy Evo ventilators that have never been used with in-line nebulizers are not affected by this issue and can continue to be used in accordance with the guidance in the field safety notice.