Trilogy Trilogy Evo Ventilator with oxygen blending model, IberiaRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00606959054097), received between Sep 24, 2020 and Jun 11, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (4 reports).

6 FDA recall records name this device's identifier, 6 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Oct 7, 2024Class IOpen, Classified

   Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could lead to inaccurate flow measurements.

   Z-0290-2025 · Root cause: Device Design · Recall details · FDA record ↗

2. Jul 16, 2024Class IOpen, Classified

   Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for affected ventilators. These updates resolve safety issues identified in earlier recalls.

   Z-2944-2024 · Root cause: Device Design · Recall details · FDA record ↗

3. Mar 19, 2024Class IOpen, Classified

   Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.

   Z-1503-2024 · Root cause: Device Design · Recall details · FDA record ↗

4. Nov 27, 2023Class IIOpen, Classified

   The following was missing from the Contraindications Statement: The AVAPS-AE therapy mode is contraindicated for invasive use and patients less than 10 kg. The AVAPS feature is contraindicated for patients less than 10 kg. Potential harms if devices are used on contraindicated patients include barotrauma, hypoventilation/hypercapnia, and rebreathing of excessive CO2.

   Z-0638-2024 · Root cause: Device Design · Recall details · FDA record ↗

5. May 1, 2023Class IOpen, Classified

   Environmental debris may accumulate on the internal machine flow sensor causing partial occlusion which may impact accurate delivery of pressure, volume, or flow. A malfunction caused by this issue can result in patient harm up to hypoxemia if not addressed by the care provider.

   Z-1650-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

6. Mar 1, 2023Class IOpen, Classified

   The accuracy of delivered oxygen may deviate below the required tolerance of 5% from setpoint when providing high concentration oxygen therapy. Additionally, if equipped, the internal FiO2 sensor may indicate a value higher than the device is actually delivering. This may lead to under delivery of oxygen.

   Z-1287-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 11, 2026Mechanical Problem; Calibration Problem

  A TRILOGY EVO DEVICE WAS RETURNED TO A SERVICE CENTER FOR MAINTENANCE. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. DURING THE EVALUATION, A SYSTEM SETUP TEST WAS PERFORMED ON A TRILOGY EVO DEVICE USING THE TRILOGY SOFTWARE, AND IT REPORTEDLY FAILED AT STEP 3, WHICH IS THE STEP THAT VERIFIES PROPER VALVE OPERATION, INDICATING A LEAK; THEREFORE, BOTH PARTS (THE PROPORTIONAL (AECM) VALVE AND THREE-WAY SOLENOID VALVES) WILL NEED TO BE REPLACED. THE MANUFACTURER'S INVESTIGATION IS ONGOING. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25475303 ↗
• MalfunctionApr 14, 2026Failure to Calibrate; Device Sensing Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE PILOT READING TEST STEP HAD FAILED ON A TRILOGY EVO O2 DEVICE. THE DEVICE WAS NOT IN PATIENT USE. THE TRILOGY EVO O2 DEVICE WAS EVALUATED BY A THIRD-PARTY SERVICE ENGINEER (SE). THE DEVICE EVALUATION FOUND THE ACTIVE EXHALATION CONTROL MODULE (AECM OR PROPORTIONAL VALVE) AND THREE-WAY (3-WAY) SOLENOID VALVE HAD CAUSED THE PILOT READING TEST STEP TO FAIL ON THE DEVICE. THE THIRD-PARTY SE REPLACED THE DEVICE'S ACTIVE EXHALATION CONTROL MODULE (AECM OR PROPORTIONAL VALVE) AND 3-WAY SOLENOID VALVE TO ADDRESS THIS ISSUE. AFTER THE THIRD-PARTY SE REPLACED THE PARTS ON THE DEVICE, THE DEVICE WAS PLACED BACK INTO SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24875211 ↗
• MalfunctionMar 18, 2026Failure to Run on Battery

  A TRILOGY EVO O2 VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR A SERVICE CHECK REGARDING A VENTILATOR INOPERATIVE FIELD SAFETY NOTIFICATION. THERE WAS NO REPORTED PATIENT INVOLVEMENT. DURING THE INITIAL EVALUATION AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE'S ERROR LOG WAS DOWNLOADED AND A VENTILATOR SERVICE REQUIRED ERROR RELATING TO AN 'INTERNAL BATTERY FAIL' WAS PRESENT. ARRANGEMENTS HAVE BEEN MADE TO REPLACE THE INTERNAL BATTERY PACK TO RESOLVE THE ERROR. THE MANUFACTURER IS SUBMITTING A FINAL REPORT AT THIS TIME. IF PERTINENT INFORMATION BECOMES AVAILABLE TO THE MANUFACTURER AT A LATER DATE, AN ADDENDUM TO THIS FINAL REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24627059 ↗
• MalfunctionNov 5, 2025Mechanical Problem; Mechanical Problem

  A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR PREVENTIVE MAINTENANCE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT A THIRD-PARTY SERVICE CENTER, AN OXYGEN PROPORTIONAL VALVE STUCK ALARM WAS OBSERVED IN THE DEVICE'S DOWNLOADED EVENT LOG. THE DEVICE'S OXYGEN BLENDING MODULE WAS REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, A LOW INLET PRESSURE ALARM WAS OBSERVED. THIS WOULD NOT AFFECT THE DEVICE'S ABILITY TO DELIVER THERAPY AS DESIGNED. THE OXYGEN BLENDING MODULE REPLACEMENT WOULD ADDRESS THIS ISSUE ALSO. THE DEVICE'S AIR INLET FOAM FILTER AND PARTICULATE FILTER WERE REPLACED DUE TO PREVENTIVE MAINTENANCE PROTOCOL. THE DEVICE WAS CLEANED AND TESTED AND PASSED ALL FINAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23479382 ↗
• MalfunctionJan 31, 2025Mechanical Problem; Mechanical Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR WAS NOT WORKING. THERE WAS NO HARM OR INJURY REPORTED. DURING EVALUATION OF THE DEVICE BY A PHILIPS REMOTE SERVICE ENGINEER, A TEST STEP FAILED DURING AN ACTIVE EXHALATION VERIFICATION. THE DEVICE DOES NOT PERFORM THE BREATHING CYCLES CORRECTLY BECAUSE THE SOLENOID VALVE RESPONSIBLE FOR OPENING AND CLOSING IN EACH CYCLE DOES NOT WORK PROPERLY. THE SOLENOID VALVE WAS REPLACED TO RESOLVE THE ISSUE. INTERNAL CLEANING WAS PERFORMED. THE NECESSARY TESTS HAVE BEEN CARRIED OUT THAT ALLOW THE CORRECT OPERATION OF THE EQUIPMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21283372 ↗
• MalfunctionJun 7, 2024Failure to Power Up; Failure to Power Up

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE DEVICE DOESN'T WORK. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER IT WAS DISCOVERED THAT A STRANGE VIBRATION NOISE IS PRODUCED DURING INHALATION AND EXHALATION, DUE TO A FAILURE IN THE VALVES OF THE OXYGEN MODULE THAT DO NOT OPEN OR CLOSE PROPERLY. THE OXYGEN BLENDING MODULE WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19482423 ↗
• MalfunctionFeb 24, 2023Circuit Failure; Mechanical Problem; Circuit Failure; Mechanical Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR SERVICE REQUIRED ALARM OCCURRED. THERE WAS NO HARM OR INJURY REPORT. THE VENTILATOR WAS RETURNED TO THE MANUFACTURE FOR EVALUATION AND THE CUSTOMER¿S COMPLAINT WAS CONFIRMED. THE DEVICE'S SYSTEM BOARD, PROPORTIONAL VALVE AND SOLENOID VALVE NEEDS TO BE REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16440003 ↗
• MalfunctionSep 13, 2022Circuit Failure; Circuit Failure

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR WAS ALARMING FOR HIGH OXYGEN PRESSURE. THERE WAS NO HARM OR INJURY REPORTED. THE VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND THE CUSTOMER'S COMPLAINT WAS CONFIRMED. THE DEVICE'S SYSTEM BOARD WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15410622 ↗
• MalfunctionSep 24, 2020Circuit Failure; Circuit Failure

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A "SERVICE REQUIRED" ALARM CONDITION OCCURRED RELATED TO AN OXYGEN ISSUE WAS OBSERVED. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, A "SERVICE REQUIRED" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S OXYGEN BLENDING MODULE BOARD WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10580337 ↗