Trilogy Evo EE2100X15BRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00606959055698), received between Aug 15, 2024 and May 19, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (3 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Oct 7, 2024Open, 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 · FDA record ↗

2. Jul 16, 2024Open, 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 · FDA record ↗

3. Mar 19, 2024Open, 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 · FDA record ↗

4. Nov 27, 2023Open, 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 · FDA record ↗

5. May 1, 2023Open, 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 · FDA record ↗

6. Mar 1, 2023Open, 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 19, 2026Circuit Failure; Electrical /Electronic Property Problem; Failure to Calibrate

  THE MANUFACTURER RECEIVED A REPORT THAT A TRILOGY EVO VENTILATOR WAS RETURNED FOR PREVENTIVE MAINTENANCE. NO PATIENT HARM OR INJURY WAS REPORTED. THE DEVICE WAS EVALUATED AT A THIRD-PARTY SERVICE CENTER. THE DEVICE LOG FILES WERE SUCCESSFULLY DOWNLOADED AND REVIEWED IN FULL. NO CRITICAL ERRORS WERE OBSERVED. DURING FUNCTIONAL TESTING, THE DEVICE FAILED THE ACTIVE EXHALATION VERIFICATION: S (+) P (-): PILOT: READING TEST. SUBSEQUENT EVALUATION IDENTIFIED AN EVENT ERROR INDICATING THAT THE SENSOR OFFSET DURING DRIFT CALCULATION WAS TOO HIGH. TO ADDRESS THE ISSUE, THE SYSTEM PRINTED CIRCUIT ASSEMBLY (PCA) WAS REPLACED. AS PART OF THE DEVICE¿S SCHEDULED FOUR-YEAR PREVENTIVE MAINTENANCE, THE AIR FOAM FILTER AND PARTICULATE FILTER WERE ALSO REPLACED. FOLLOWING THE REPAIR, THE DEVICE PASSED ALL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25216721 ↗
• MalfunctionMay 8, 2026Mechanical Problem

  A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION SERVICE REQUIRED ALARM CONDITIONS INDICATING A FAILURE OF THE OXYGEN BLENDING MODULE WERE OBSERVED IN THE DEVICE'S DOWNLOADED EVENT LOG. THE DEVICE'S OXYGEN BLENDING MODULE NEEDS TO BE REPLACED TO ADDRESS THE ISSUE. ADDITIONAL ERRORS WERE OBSERVED REQUIRING THE SYSTEM BOARD TO BE REPLACED. THESE ERRORS WOULD NOT AFFECT THE DEVICE'S ABILITY TO DELIVER THERAPY AND ARE NOT REPORTABLE ISSUES. 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, A FOLLOW UP/SUPPLEMENTAL REPORT WILL BE COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25125970 ↗
• MalfunctionJan 23, 2026Electrical /Electronic Property Problem; Mechanical Problem

  A TRILOGY EVO O2, EASTERN EUROPE VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE DUE TO AN ALLEGATION THAT THE "O2 TOO NOISY, HIGH O2 DOES NOT WORK PROPERLY". THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS NOT REPORTED TO BE IN PATIENT USE. DURING THE EVALUATION OF THE TRILOGY EVO O2, EASTERN EUROPE DEVICE AT THIRD-PARTY SERVICE CENTER, AN EVT_MOTOR_SHUTDOWN ERROR INDICATING A VENTILATOR INOPERATIVE AS A GENERIC MOTOR FAILURE EVENT CODE WAS DISCOVERED IN THE DEVICE'S EVENT LOG. THIS INDICATES THAT THE DEVICE'S BLOWER IS DEFECTIVE AND WILL REQUIRE REPLACEMENT. ADDITIONALLY, AN EVT_OBM_VALVE_FAILURE ERROR INDICATING THAT THE O2 PROPORTIONAL VALVE THAT CONTROLS THE FLOW OF O2 TO THE BLOWER INLET IS MECHANICALLY STUCK CLOSED OR OPEN WAS DISCOVERED IN THE DEVICE'S EVENT LOG. THE DEVICE'S OXYGEN BLENDING MODULE BOARD NEEDS TO BE REPLACED TO ADDRESS THE ISSUE. FURTHERMORE, NOT RELATED TO THE ISSUE, THE MACHINE FLOW SENSOR HAS TO BE REPLACED DUE TO AN EVT_DRIFT_DEBUG ERROR INDICATING THAT THE SENSOR OFFSET DURING DRIFT CALCULATION IS TOO HIGH OCCURRED AFTER PERFORMING THE PNEUMATIC STEP. THE AIR FOAM INLET FILTER, PARTICULATE FILTER WILL BE REPLACED DUE TO THE 4-Y

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24160588 ↗
• MalfunctionSep 5, 2024Infusion or Flow Problem; Infusion or Flow Problem

  THE MANUFACTURER RECEIVED INFORMATION A SERVICE ALARM O2 REGULATION FAILURE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT A THIRD-PARTY SERVICE CENTER, AN O2 FLOW DRIFT HIGH AND OXYGEN BLENDING MODULE VALVE FAILURE ERROR CODES WERE FOUND IN THE DEVICE'S ERROR LOG. THE DEVICE'S OXYGEN BLENDING MODULE SUBASSEMBLY NEEDS TO BE REPLACED TO RESOLVE THE ISSUE. ADDITIONALLY, THE PCA BOARD NEEDS TO BE REPLACED. ALSO, THE AIR FOAM INLET FILTER NEEDS TO BE REPLACED DUE TO PREVENTATIVE MAINTENANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20147667 ↗
• MalfunctionAug 15, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN OUT OF ORDER CONDITION OCCURRED. THERE WAS NO HARM OR INJURY 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 19990140 ↗