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

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00606959055674), received between Mar 9, 2021 and May 28, 2026 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (10 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-1502-2024 · 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2026Circuit Failure; Electrical /Electronic Property Problem

  A TRILOGY EVO O2 EU VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO ALLEGATION OF HARM OR INJURY REPORTED, AND THE DEVICE WAS NOT REPORTED TO BE IN PATIENT USE AT THE TIME OF THE EVENT. DURING EVALUATION AT THE THIRD-PARTY SERVICE CENTER, AN ERROR WAS IDENTIFIED INDICATING THAT THE O2 PROPORTIONAL VALVE CONTROLLING THE FLOW OF O2 TO THE BLOWER INLET WAS MECHANICALLY STUCK OPEN OR CLOSED. TO ADDRESS THE ISSUE, THE DEVICE'S PRINTED CIRCUIT ASSEMBLY BOARD WAS REPLACED. ADDITIONALLY, THE SOFTWARE WAS UPDATED TO VERSION 1.06.15.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25326048 ↗
• MalfunctionMar 18, 2026Electrical /Electronic Property Problem; Mechanical Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING "WATER HAS ENTERED TYPE O2 (WHITE CONNECTION) OF A TRILOGY EVO, O2, EU DEVICE. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS NOT REPORTED TO BE IN PATIENT USE. DURING THE "INPROCESS" EVALUATION OF THE TRILOGY EVO, O2, EU DEVICE AT THIRD-PARTY SERVICE CENTER, IT WAS DOCUMENTED THAT DUE TO EVT_O2_PROP_STUCK AND EVT_O2_REGULATION ERRORS IT APPEARS THAT THE OXYGEN BLENDING MODULE IS DEFECTIVE AND WILL NEED TO BE REPLACED. ADDITIONALLY, NOT RELATED WHILE TESTING THE DEVICE EVT_VOLTAGE_3VS3_FAIL AND EVT_VOLTAGE_5VS2_FAIL ERROR CODES APPEARED, WHICH INDICATE THAT THE SYSTEM BOARD IS DEFECTIVE AND NEEDS TO BE REPLACED. THE DEVICE'S BLOWER, BLOWER CHASSIS PLATE, LOW-FLOW TUBE, BELLOW, SYSTEM BOARD TUBING, MACHINE FLOW SENSOR, FIO2 TUBING, AND BLOWER CHASSIS PLATE TUBING WILL NEED TO BE REPLACED DUE TO CONTAMINATION OF WATER. PER THE REQUIREMENTS OF THE FOUR-YEAR MAINTENANCE THE DEVICE'S AIR FOAM INLET FILTER, PARTICULATE FILTER INTERNAL AND DETACHABLE BATTERY WILL BE REPLACED. A FINAL REPORT IS BEING SUBMITTED. IF NEW INFORMATION BECOMES AVAILABLE FOLLOWING THE COMPLETION OF THE DEVICE REPAIR THAT CHANGES THE OUTCOME OF THE INVESTIGATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24626402 ↗
• MalfunctionJul 11, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A TRILOGY EVO WAS ALARMING INDICATING THE FIO2 SENSOR HAD RAILED. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS NOT IN PATIENT USE. THE DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER, AND THOSE ERRORS WERE NOTED BUT ARE NOT ACTIONABLE ERROR CODES. ADDITIONAL REVIEW OF THE DOWNLOADED EVENT LOG REVEALED AN O2 PROPORTIONAL VALVE STUCK ALARM. THE DEVICE'S OXYGEN BLENDING MODULE SUBASSEMBLY WAS REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, AN O2 REGULATION AND LOW O2 INLET PRESSURE ALARMS WERE OBSERVED. THE OXYGEN BLENDING MODULE SUBASSEMBLY WAS REPLACED DUE TO THESE ERRORS ALSO, ALTHOUGH THEY WOULD NOT AFFECT THE DEVICE'S ABILITY TO DELIVER THERAPY AS DESIGNED. THE DEVICE'S INLET FOAM FILTER AND PARTICULATE FILTER WERE REPLACED PER PREVENTIVE MAINTENANCE PROTOCOL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22480783 ↗
• MalfunctionJan 30, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A RED ALARM CONDITION OCCURRED. NO HARM OR INJURY WAS REPORTED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21272723 ↗
• MalfunctionMar 29, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19003387 ↗
• MalfunctionMar 21, 2024Electrical /Electronic Property Problem; Gas Output Problem; Decrease in Pressure; Electrical /Electronic Property Problem; Gas Output Problem; Decrease in Pressure

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A TRILOGY EVO O2 RED ALARM AND O2 OUTLET PRESSURE LOW CONDITION OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18950035 ↗
• MalfunctionJan 5, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, A "VENT INOP" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S SYSTEM BOARD WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18456369 ↗
• MalfunctionJul 24, 2023Mechanical Problem; Mechanical Problem

  A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE 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. ADDITIONALLY, THE AIR INLET FILTER WAS REPLACED WHICH WAS NOT RELATED TO THE MALFUNCTION/ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17385466 ↗
• MalfunctionMay 5, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED. 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 16876010 ↗
• MalfunctionDec 28, 2022Contamination; Mechanical Problem; Contamination; Mechanical Problem

  A VENTILATOR WAS RETURNED TO A THIRD PARTY SERVICE CENTER FOR EVALUATION. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE THIRD PARTY SERVICE CENTER, A "SERVICE REQUIRED" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S MACHINE FLOW SENSOR WAS CLEANED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16059508 ↗
• MalfunctionNov 30, 2022Circuit Failure; Circuit Failure

  A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THIRD-PARTY SERVICE CENTER, A "SERVICE REQUIRED" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S SYSTEM BOARD, MACHINE FLOW SENSOR, AND OXYGEN BLENDING MODULE BOARD WERE REPLACED TO ADDRESS THE ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15888210 ↗
• MalfunctionNov 4, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, VENTILATOR INOPERATIVE CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S SYSTEM BOARD WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15724224 ↗
• MalfunctionOct 27, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  A VENTILATOR WAS RETURNED TO A THIRD PARTY SERVICE CENTER FOR EVALUATION. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT THE THIRD PARTY SERVICE CENTER, A "VENTILATOR INOPERATIVE" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S SYSTEM BOARD WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15678992 ↗
• MalfunctionAug 2, 2022Circuit Failure; Circuit Failure

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED. 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 15149203 ↗
• MalfunctionSep 16, 2021Failure to Recalibrate; Failure to Recalibrate

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR'S PARAMETERS COULD NOT BE ADJUSTED. 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 WAS RECALIBRATED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12480517 ↗
• MalfunctionMar 9, 2021Circuit Failure; Circuit Failure

  A VENTILATOR WAS RETURNED TO A THIRD PARTY SERVICE CENTER FOR EVALUATION. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE VENTILATOR AT THE THIRD PARTY SERVICE CENTER, SERVICE REQUIRED" CODES WERE FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S SYSTEM BOARD WAS REPLACED TO ADDRESS THE ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11446915 ↗