Trilogy Evo CA2110X12BRecalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00606959052307), received between Sep 15, 2021 and Dec 9, 2025 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (10 reports).

4 FDA recall records name this device's identifier, 4 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-0291-2025 · 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-1504-2024 · 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 ↗

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 9, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE TOUCHSCREEN WAS DAMAGED ON A TRILOGY EVO DEVICE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. THE TRILOGY EVO DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION, AND THE CUSTOMER¿S COMPLAINT WAS CONFIRMED. DURING THE EVALUATION, THE THIRD-PARTY SERVICE TECHNICIAN DID NOT PROVIDE ANY FINDINGS ON THE CAUSE OF THE DAMAGE DISPLAY FOR THIS DEVICE. IN CONCLUSION, THE DEVICE'S DISPLAY SCREEN WAS REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, THE DETACHABLE BATTERY PACK, MUFFLER ASSEMBLY, AND AIR INLET FOAM FILTER WERE REPLACED FOR PREVENTATIVE MAINTENANCE UNRELATED TO THE REPORTABLE ISSUE. THE PARTICLE FILTER, SYSTEM PRINTED CIRCUIT ASSEMBLY TUBING, BLOWER CHASSIS TUBING, FIO2 TUBING, AND LOW FLOW O2 TUBING WERE REPLACED FOR CONTAMINATION UNRELATED TO THE REPORTABLE ISSUE. THE DEVICE PASSED ALL FINAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23763744 ↗
• MalfunctionOct 15, 2025Failure to Calibrate; Device Sensing Problem; Failure to Calibrate; Device Sensing Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE ACTIVE EXHALATION VERIFICATION TEST STEP HAD FAILED DURING PREVENTATIVE MAINTENANCE ON A TRILOGY EVO DEVICE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. THE TRILOGY EVO DEVICE WAS EVALUATED AT THE THIRD-PARTY SERVICE CENTER. DURING THE EVALUATION IT WAS NOTED THAT THE DEVICES PROPORTIONAL VALVE AND THREE-WAY (3-WAY) SOLENOID VALVE HAD CAUSED THE ACTIVE EXHALATION VERIFICATION TEST STEP TO FAIL ON THE DEVICE. IN CONCLUSION, THE DEVICE'S PROPORTIONAL VALVE AND 3-WAY SOLENOID VALVE NEEDS REPLACED TO ADDRESS THE ISSUE. THE ROOT CAUSE IS CONFIRMED AT THIS TIME. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, THE FRONT PANEL NEEDS REPLACED FOR PHYSICAL DAMAGE UNRELATED TO THE REPORTABLE ISSUE. THE PARTICULATE FILTER, MUFFLER ASSEMBLY, AND AIR INLET FOAM FILTER NEEDS REPLACED FOR PREVENTATIVE MAINTENANCE UNRELATED TO THE REPORTED ISSUE. THE VANITY COVER, BLOWER BELLOWS SEAL, BLOWER MOUNT, INTERNAL BATTERY DOOR, BASE ASSEMBLY, FAN RETAINER, SYSTEM PRINTED CIRCUIT ASSEMBLY TUBING, BLOWER CHASSIS, FIO2 TUBING, AND LOW FLOW TUBING NEEDS REPLACED FOR CONTAMINATION UNRELATED TO THE REPORTABLE ISSUE. PER THE CUSTOMER'S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23295059 ↗
• MalfunctionAug 9, 2025Battery Problem; Device Sensing Problem; Battery Problem; Device Sensing Problem

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR ROUTINE PREVENTATIVE MAINTENANCE. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. THE WAS NO PATIENT HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, AN ERROR CODE RELATED TO THE CHARGING OF THE INTERNAL BATTERY WAS OBSERVED. THE DEVICE'S INTERNAL BATTERY WAS REPLACED TO ADDRESS THE ISSUE. IN ADDITION, AN ERROR CODE REGARDING THE FLOW SENSOR WAS OBSERVED. THE DEVICE'S FLOW SENSOR WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22766655 ↗
• MalfunctionAug 1, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE ERROR CODE OCCURRED ON A TRILOGY EVO DEVICE RELATING TO DATA BEING CORRUPTED. THE CUSTOMER STATES THAT REINSTALLING THE SOFTWARE DID NOT RESOLVE THE ISSUE. THERE WAS NO HARM OR INJURY REPORTED. THERE WAS NO REPORTED PATIENT INVOLVEMENT. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22688493 ↗
• MalfunctionJul 16, 2025Battery Problem; Power Problem; No Tactile Prompts/Feedback; Battery Problem; Power Problem; No Tactile Prompts/Feedback

  THE MANUFACTURER PREVIOUSLY WAS INFORMED A VENTILATOR WAS ALARMING DUE TO A KEYPAD BEING STUCK AND UNABLE TO POWER OFF THE DEVICE. THE CUSTOMER INDICATED THE DEVICE WAS ABLE TO BE POWERED OFF AFTER A FEW MINUTES. THE EVALUATION HAD NOT YET BEEN COMPLETED. THE DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION. DURING THE EVALUATION A SERVICE REQUIRED ALARM INDICATING THE TOUCHSCREEN FAILED WAS OBSERVED. THE DEVICE'S DISPLAY AND DISPLAY BOARD WERE REPLACED TO ADDRESS THE ISSUE. AN ALARM INDICATING ALL POWER SOURCES WERE DEPLETED WAS OBSERVED. THE SYSTEM BOARD WAS REPLACED TO ADDRESS THE ISSUE. THE INTERNAL BATTERY WAS REPLACED TO ADDRESS AN INTERNAL BATTERY DEPLETED ALARM CONDITION. ADDITIONALLY, THE DEVICE'S PARTICULATE FILTER, BLOWER BELLOWS SEAL, BLOWER MOUNT, COOLING FAN ASSEMBLY, FAN RETAINER, MACHINE FLOW SENSOR, MUFFLER ASSEMBLY, SYSTEM BOARD TUBING, BLOWER CHASSIS TUBING, FIO2 TUBING AND LOW FLOW O2 TUBING WERE ALL REPLACED DUE TO CONTAMINATION AND YELLOWING. THE DEVICE WAS TESTED AND PASSED ALL FINAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22521217 ↗
• MalfunctionMay 16, 2025No Audible Prompt/Feedback; No Audible Prompt/Feedback

  THE MANUFACTURER RECEIVED AN ALLEGATION THAT THE VENTILATOR DID NOT ALARM AFTER PATIENT DISCONNECTION. 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 22040911 ↗
• MalfunctionMay 16, 2025Electrical /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 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 22040906 ↗
• MalfunctionFeb 25, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A TRILOGY EVO VENTILATOR FAILED AND WAS CONTINUALLY ALARMING. THE CUSTOMER WAS UNABLE TO SILENCE THE DEVICE. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. 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 21458090 ↗
• MalfunctionJan 10, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR WAS ALARMING FOR A VENTILATOR INOPERATIVE ALARM CONDITION. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. 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 21126370 ↗
• MalfunctionNov 6, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A TRILOGY EVO VENTILATOR INOPERATIVE CONDITION OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE HAS NOT YET 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 20622774 ↗
• MalfunctionNov 6, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A TRILOGY EV0 VENTILATOR INOPERATIVE CONDITION OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE HAS NOT YET 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 20621599 ↗
• MalfunctionMay 21, 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 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 19361558 ↗
• MalfunctionApr 11, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED WHILE IN PATIENT USE. 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 SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19092829 ↗
• MalfunctionMar 21, 2024No Display/Image; No Display/Image

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A MALFUNCTION OF A VENTILATOR'S TOUCHSCREEN. 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 18951896 ↗
• MalfunctionMar 6, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A TRILOGY EVO VENTILATOR HAD A FLASHING SCREEN. THERE WAS NO HARM OR INJURY REPORTED. THE CUSTOMER WAS INSTRUCTED TO TRY A NEW POWER CORD TO SEE IF THE ISSUE WOULD BE RESOLVED. THE DEVICE CONTINUES TO FLASH DESPITE THE NEW POWER CORD. 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 18844929 ↗
• MalfunctionFeb 21, 2024Battery Problem; Battery Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A TRILOGY EVO "VENTILATOR INOPERATIVE CONDITION OCCURRED. THE CUSTOMER STATES THE DEVICE TURNED OFF WHILE BEING MOVED FROM A ROLL STAND TO A WHEELCHAIR BRACKET. THE CUSTOMER STATES THE INTERNAL AND EXTERNAL BATTERIES WERE BOTH CHANGED AND WERE BOTH PLUGGED INTO AC POWER PRIOR TO THE DEVICE BEING MOVED. ONCE THE DEVICE WAS UNPLUGGED TO BE MOVE THE DEVICE RANDOMLY TURNED OFF. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS SENT TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, ERROR CODE E-325 WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. 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 18746954 ↗
• MalfunctionFeb 13, 2024No Display/Image; Unexpected Shutdown; No Display/Image; Unexpected Shutdown

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE DEVICE ALARMED LOUDLY AND BECAME NON-RESPONSIVE DURING PATIENT USE. ALSO, THE DELIVERY SCREEN WAS NOT VISIBLE MAKING IT IMPOSSIBLE TO READ THE VALUES. 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 18695934 ↗
• MalfunctionDec 19, 2023Battery Problem; Filtration Problem; Battery Problem; Filtration Problem

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. "CUSTOMER COMPLAINS THAT THEY KEEP GETTING AN INLET FILTER BLOCKED ALARM THAT KEEPS RETURNING. CUSTOMER COMPLAINS THAT THEY KEEP GETTING AN ALARM THAT SAYS INTERNAL BATTERY NEARLY DEPLETED. THE PATIENT REPORTED ANXIETY AS HARM". THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18360411 ↗
• MalfunctionAug 22, 2023Defective Alarm; Defective Alarm

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THAT THE VENTILATOR ALARM WAS NOT WORKING. 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 17597898 ↗
• MalfunctionJun 22, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR'S SCREEN WAS GLITCHING. 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 17183041 ↗
• MalfunctionFeb 20, 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 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 16403128 ↗
• MalfunctionFeb 7, 2022Failure to Power Up; Failure to Power Up

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. 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 13471610 ↗
• MalfunctionSep 15, 2021Failure to Charge; Failure to Charge

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A "SERVICE REQUIRED" ALARM CONDITION INDICATING THE DEVICE'S BATTERY WAS NOT CHARGING HAD OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE HAS NOT YET 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 12474941 ↗