Philips Recalls Trilogy Evo Ventilators for Lung Injury Risks When Used With Nebulizers

The manufacturer has become aware of nearly 1,000 reports of the Trilogy Evo ventilator malfunctioning with nebulizers, resulting in three serious injuries.

Federal safety officials have announced a recall for Philips Respironics Trilogy ventilators, warning that aerosol deposits may form on the flow sensors when several models are used with in-line nebulizers that are placed improperly, potentially impairing the devices functionality and increasing the risk of lung injuries.

The U.S. Food and Drug Administration (FDA) announced the Philips Respironics Trilogy ventilator recall on October 7, providing updated guidance to address the specific placement of in-line nebulizers to avoid the formation of aerosol deposits on the ventilator’s flow sensor.

The Trilogy Evo ventilators are medical devices designed to assist patients with compromised respiratory functions, which are equipped with various settings to tailor respiratory support based on individual needs.

These devices are widely used in both clinical and home settings, often in conjunction with in-line nebulizers to help administer medications directly to the lungs, addressing various respiratory symptoms in a controlled manner.

Philips Respironics indicates that it has received at least 928 reports of problems linked to issues with the flow sensors on the Trilogy ventilators, including three incidents that resulted in serious patient injuries.

Officials are warning healthcare providers and patients to follow the updated usage instructions carefully to prevent any potential hazards that could arise from improper placement of in-line nebulizers.

Philips Respironics first issued an Urgent Field Safety Notice on September 19, warning customers that if aerosol deposits accumulate on the flow sensor, there is a possibility of patient impact due to the ventilator becoming inoperative, leading to a delay in therapy and adverse health risks.

The notice further indicated the malfunction may result in over-delivery of inhaled and exhaled air, or the under-delivery of oxygen for devices when set at specific oxygen concentration setting. This can lead to respiratory discomfort or potentially severe lung injuries, due to too much air entering the lungs, change in pressure, low oxygen saturation, or shortness of breath.

The instructions for use recall update impacts the following Philips Respironics ventilators that are designed to be used with in-line nebulizers:

• Trilogy Evo
• Trilogy Evo O2
• Trilogy Evo Universal
• Trilogy EV300 ventilators

Those using the recalled ventilators are being advised to ensure that specific alarms are appropriately set and that alternate sources of ventilation are available in case a ventilator ceases to function.

If in-line nebulizers are being used for treatment, medical providers and caregivers are advised to follow the visual instructions in the field safety notice for correct nebulizer placement, and to transition patients to alternative device configurations if the prescribed treatments are listed in the safety notice.

Philips Respironics is continuing to investigate a solution and will provide additional information when it becomes available.

For more information, DMEs and Homecare customers can contact Philips Respironics Customer Service at 1-800-345-6443, option 4 then 5. Hospital customers can reach the company’s customer service at 1-800-722-9377, option 2.

Any adverse events experienced with the use of the product should be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch Web site at www.fda.gov/medwatch.