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

Summary

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.

Potential patient impacts

As indicated in the Urgent Medical Device Correction (Field Safety Notice in the rest of world), if aerosol deposits accumulate over time on the flow sensor, there is a possibility of patient impact due to one or more of the following conditions: the ventilator may become 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).

Potential hazards to patients from these conditions may include: respiratory discomfort; lung injury from too much air in the lungs or change in pressure (volutrauma/barotrauma); low oxygen saturation; or shortness of breath (dyspnea).

Customer / user immediate actions required

1. 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.
   • Ensure that alternate sources of ventilation are available in case a ventilator ceases to function.
2. 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.
   • As indicated in the Instructions for use, maintain an immediately available back‐up device or alternative ventilator for rapid therapy transition.
3. 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.

Customers who require further information or support concerning this issue, may contact their local Philips Respironics Customer Service at:

• For DMEs and Homecare customers: 1-800-345-6443, press option 4, then option 5
• For Hospital customers: 1 (800) 722-9377, press option 2

Any adverse events experienced with the use of this 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.