Philips Respironics Releases Extra Guidelines for Trilogy Evo Ventilator Users Concerning In-Line Nebulizer Applications

Summary

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Company Announcement

• Philips has issued additional usage instructions as a voluntary amendment (Urgent Medical Device Correction in the US, Field Safety Notice elsewhere).
• The instructions outline user actions and guidance for continued use of affected devices.
• No specific instances of malfunction related to the use of inline nebulizers have been reported; the issue was identified via an internal review of flow sensor performance.

Philips Respironics

The company has released an update regarding the use of in-line nebulizers with Trilogy Evo, Trilogy Evo O2, Trilogy Evo Universal, and Trilogy EV300 ventilators.

An Urgent Medical Device Correction and Field Safety Notice will inform healthcare systems and distributors, ensuring timely communication to patients using these devices at home.

Patients are encouraged to consult their healthcare provider before making any changes to their therapy. The update includes guidelines for user actions and improved usage of the affected devices. Philips Respironics is actively working on a solution and will share updates as they arise.

No patient fatalities have been reported in connection with this issue as part of ongoing quality assurance efforts.

In-line nebulizers, a common accessory, convert therapeutic liquids into aerosol to treat various respiratory conditions.

Philips Respironics has found that placing in-line nebulizers in specific locations may lead to aerosol deposits on ventilator flow sensors, potentially causing airflow inaccuracies and therapy disruptions.

Ventilators that have not been used with in-line nebulizers are unaffected and can continue operation as per the safety notice guidelines.

Potential patient impacts

As outlined in the Urgent Medical Device Correction (Field Safety Notice), aerosol buildup may lead to:

• Inoperability of the ventilator after powering down, which can delay therapy.
• Variability in inhaled and exhaled air volume (tidal volume) and/or inadequate oxygen delivery in devices with specific settings (FiO2).

Potential risks include respiratory discomfort, lung injury from excessive air or pressure changes, low oxygen levels, or difficulty breathing.

Immediate actions for customers/users

1. All users of Trilogy Evo models should adhere to the following steps from device Instructions for Use:
   • Set alarms appropriately for the patient.
   • Have alternate ventilation options ready in case of device failure.
2. If using devices with a specific oxygen concentration:
   • Continuously monitor oxygen levels (SpO2) as per treatment protocols.
   • Utilize an external FiO2 analyzer for certain cases, switching to an alternative ventilator if necessary.
   • Keep a backup device accessible for swift therapy adjustments.
3. For in-line nebulizer treatments:
   • Follow the placement guidelines in the field safety notice.
   • Transition patients to alternative device configurations as specified in the safety notice.

For further inquiries or support regarding this issue, contact Philips Respironics Customer Service:

• 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

Adverse events related to this product should be reported to the FDA’s MedWatch Program via phone at 1-800-FDA-1088, fax at 1-800-FDA-0178, mail to MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.