Philips issues correction for vents 

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

The company 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 patient impact due to one or more of the following conditions: inoperative following stand by or powering off, leading to delay in therapy; and over-delivery of inhaled and exhaled air (tidal volume) and/or under-delivery of oxygen for devices with a specific concentration setting (FiO2).  

Philips is sending health systems and equipment distributors urgent medical device corrections with additional usage instructions and guidance for continued use of affected devices: 

• All Trilogy Evo, Trilogy Evo O2, Trilogy Evo Universal, and Trilogy EV300 users, regardless of in-line nebulizer use are advised to take the following steps from the device Instructions for Use: Ensure that specific alarms are set appropriately for patients, and ensure that alternate sources of ventilation are available in case a ventilator ceases to function. 
• If using a Trilogy Evo O2, Trilogy Evo Universal, or Trilogy EV300 device with a specific oxygen concentration (FiO2) setting: Ensure patients receive adequate oxygenation by continuous pulse oximetry (SpO2) monitoring in accordance with treatment protocols; use an external FiO2 analyzer in specific patient cases, and switch to an alternative ventilator if an external FiO2 analyzer is not available; and as indicated in the Instructions for use, maintain an immediately available back‐up device or alternative ventilator for rapid therapy transition. 
• If using in-line nebulizer treatments: Follow the visual instructions in the field safety notice for correct nebulizer placement; for specific prescriptions indicated in the field safety notice, transition patient to alternate device configurations. 

Philips says it has not received any specific complaints of device malfunctions resulting from in-line nebulizer use, but the issue was identified through a retrospective review of flow sensor performance. At the time of the notification, the company says no deaths have been reported. 

The company says it is investigating a solution and will provide additional information when available. 

For the full update, go here.