Trilogy Trilogy Evo Ventilator, EURecalls & reported problems

Summary

The FDA's MAUDE database contains 69 adverse event reports that list this exact device (DI 00606959054981), received between Sep 24, 2020 and Sep 28, 2026 — classified as 69 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (32 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 16, 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-0291-2025 · Root cause: Device Design · Recall details · 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 · Recall details · 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-1504-2024 · Root cause: Device Design · Recall details · 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 69 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Battery Problem

  The manufacturer received information that a Trilogy Evo ventilator was returned to a third-party service center for evaluation. No patient involvement or harm was reported.During the preliminary "INPROCESS" evaluation of the device at the third-party service center, an error code 059, EVT_BATTERY_NOT_CHARGING_FAULT, indicated a hardware fault preventing the internal or detachable Li-Ion battery from charging. The detachable battery was determined to require replacement.Additionally, the device had a non-actionable error code for 330-Sensor offset during drift calculation is too high and 386-Machine flow sensor offset greater. Evaluation/repair of the device is anticipated but has not yet begun because the service provider is awaiting customer approval of the service quotation. The manufacturer's investigation is ongoing. If additional relevant information becomes available, a supplemental report will be submitted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917271 ↗
• MalfunctionSep 11, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50738234 ↗
• MalfunctionJun 25, 2026Circuit Failure; Device Sensing Problem

  A TRILOGY EVO DEVICE WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER WITH AN ALLEGATION OF A VENTILATOR INOPERATIVE ALARM AFTER A SOFTWARE UPDATE. NO MEDICAL INTERVENTION WAS SPECIFIED. THE DEVICE WAS NOT REPORTED TO BE IN CLINICAL USE. THE TRILOGY EVO WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR EVALUATION, AND THE CUSTOMER¿S COMPLAINT WAS CONFIRMED. IN ADDITION, DURING THE EVALUATION IT WAS NOTED THAT A CODE REGARDING A FAILURE IN THE MACHINE FLOW SENSOR WAS OBSERVED. IN CONCLUSION, THE DEVICE'S PCA (PATIENT CIRCUIT ASSEMBLY) AND THE MACHINE FLOW SENSOR NEEDS TO BE REPLACED TO ADDRESS THE ISSUE. SHOULD FURTHER INVESTIGATION PROVIDE NEW INFORMATION THAT IMPACTS THE OUTCOME OF THE INVESTIGATION OR THE ASSOCIATED MEDICAL DEVICE REPORTING, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25620982 ↗
• MalfunctionJun 18, 2026Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION THAT A TRILOGY EVO VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR COMPLETION OF PREVENTATIVE MAINTENANCE. THERE WAS NO PATIENT INVOLVEMENT, AND NO HARM OR INJURY REPORTED. ON EVALUATION, A CRITICAL DEVICE ERROR CODE E-386 WAS NOTED IN THE ERROR LOG INDICATING MACHINE FLOW SENSOR OFFSET GREATER THAN 0.2 SLPM. THE MACHINE FLOW SENSOR REQUIRED REPLACEMENT TO ADDRESS THIS ISSUE. ADDITIONAL FINDINGS NOT RELATED TO THE MALFUNCTION/ISSUE: THE SYSTEM PRINTED CIRCUIT BOARD ASSEMBLY REQUIRED REPLACEMENT AND INTERIOR COMPONENTS WERE NOTED TO BE CONTAMINATED WITH DUST. PREVENTATIVE MAINTENANCE WITH REQUIRED COMPONENT REPLACEMENTS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25549256 ↗
• MalfunctionMay 28, 2026Circuit Failure; Electrical /Electronic Property Problem; Battery Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING ACTIONABLE ERRORS OCCURRED ON A TRILOGY EVO VENTILATOR FOLLOWING COMPLETION OF A SOFTWARE UPGRADE. NO PATIENT HARM OR INJURY WAS REPORTED. THE DEVICE WAS NOT IN PATIENT USE AT THE TIME OF THE EVENT. AFTER SUCCESSFUL COMPLETION OF THE SOFTWARE UPDATE, DEVICE ERROR LOGS WERE REVIEWED BY A THIRD-PARTY SERVICE TECHNICIAN. THE REVIEW IDENTIFIED AN EVT_TPY_HELD_IN_BM ¿VENTILATOR INOPERATIVE¿ ALARM INDICATING THE THERAPY CENTRAL PROCESSING UNIT (CPU) IS STILL RUNNING IN BOOT MONITOR SOFTWARE. REPLACEMENT OF THE DEVICE¿S SYSTEM PRINTED CIRCUIT ASSEMBLY (PCA) WAS DETERMINED TO BE NECESSARY TO CORRECT THIS ISSUE. ADDITIONALLY, AN EVT_INTERNAL_BATT_FAILED ERROR WAS IDENTIFIED IN THE EVENT LOG, INDICATING THE INTERNAL LITHIUM-ION BATTERY IS REPORTING A PERMANENT FAILURE. REPLACEMENT OF THE INTERNAL BATTERY WAS DETERMINED TO BE NECESSARY. UNRELATED TO THE REPORTED MALFUNCTION, THE DETACHABLE LITHIUM-ION BATTERY ALSO REQUIRES REPLACEMENT DUE TO AN EVT_DETACH_BATT_FAILED ERROR, INDICATING A PERMANENT FAILURE CONDITION. A FINAL REPORT IS BEING SUBMITTED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25325760 ↗
• MalfunctionMay 27, 2026Circuit Failure; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE ("VENT INOP") ERROR HAD OCCURRED ON A TRILOGY EVO VENTILATOR FOLLOWING COMPLETION OF A SOFTWARE UPGRADE. NO PATIENT HARM OR INJURY WAS REPORTED. FOLLOWING SUCCESSFUL COMPLETION OF THE SOFTWARE UPDATE, THE DEVICE ERROR LOGS WERE REVIEWED BY A THIRD-PARTY SERVICE TECHNICIAN. REVIEW IDENTIFIED A "VENT INOP" ALARM ASSOCIATED WITH AN RIPC COMMUNICATION FAILURE BETWEEN THE THERAPY AND USER INTERFACE CENTRAL PROCESSING UNITS (CPUS). REPLACEMENT OF THE DISPLAY PRINTED CIRCUIT ASSEMBLY (PCA) AND SYSTEM PCA WAS DETERMINED TO BE NECESSARY TO CORRECT THE ISSUE. ADDITIONALLY, UNRELATED TO THE REPORTABLE MALFUNCTION, THE PCA ALSO REQUIRES REPLACEMENT DUE TO AN EVT_PRESSPAIR_ERR EVENT ERROR, WHICH IS A DEBUG MESSAGE ASSOCIATED WITH TRANSIENT SENSOR EVENTS. A FINAL REPORT IS BEING SUBMITTED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25305125 ↗
• MalfunctionMay 27, 2026Circuit Failure; Battery Problem

  THE MANUFACTURER RECEIVED INFORMATION THAT A TRILOGY EVO VENTILATOR HAD CRITICAL ERROR CODES OCCUR. THERE WAS NO PATIENT INVOLVEMENT, AND NO HARM OR INJURY REPORTED. INFORMATION RECEIVED WITH DETAILS FOR THIS DEVICE TRILOGY EVO SN H32070825D37F THERE WAS ERROR CODE E0047 INDICATING THE INTERNAL BATTERY FAILED AND ERROR CODE E0156, WHICH REPRESENTS A VENTILATOR INOPERATIVE CONDITION OF THE THERAPY CENTRAL PROCESSING UNIT (CPU) STILL RUNNING IN BOOT MONITOR SOFTWARE. PHILIPS IS CURRENTLY INVESTIGATING THIS COMPLAINT; HOWEVER, THE DEVICE EXAMINATION HAS NOT YET BEGUN BECAUSE THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. AT THIS TIME, THE MANUFACTURER IS UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25304460 ↗
• MalfunctionMay 27, 2026Circuit Failure; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE ERROR HAD OCCURRED ON A TRILOGY EVO DEVICE AFTER SOFTWARE UPGRADE WAS PERFORMED. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. DURING THE EVALUATION IT WAS NOTED THAT AN ERROR CODE, RIPC COMMUNICATION FAILURE BETWEEN THE THERAPY AND USER INTERFACE CENTRAL PROCESSING UNITS (CPUS), WAS OBSERVED ON THE DEVICE'S ERROR LOG. THE THIRD-PARTY SERVICE TECHNICIAN FURTHER EVALUATED AND DETERMINED THE DISPLAY PRINTED CIRCUIT ASSEMBLY (PCA) AND SYSTEM PCA HAD CAUSED THE VENTILATOR INOPERATIVE TO OCCUR ON THE DEVICE. IN CONCLUSION, THE DEVICE'S DISPLAY PCA AND SYSTEM PCA WERE REPLACED TO ADDRESS THE ISSUE. THE ROOT CAUSE IS CONFIRMED AT THIS TIME. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, THE DISPLAY PCA AND SYSTEM PCA WERE REPLACED FOR ANOTHER ERROR CODE, EVENT PRESSPAIR ERROR, WAS OBSERVED ON THE DEVICE'S ERROR LOG. THIS WAS UNRELATED TO THE REPORTABLE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25303578 ↗
• MalfunctionApr 15, 2026Circuit Failure; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION FROM A CUSTOMER THAT WHEN SETTING LARGE VALUES ON A TRILOGY EVO, THE SCREEN TURNS RED AND STOPS. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24885883 ↗
• MalfunctionApr 9, 2026Computer Software Problem; Unexpected Shutdown

  THE MANUFACTURER RECEIVED INFORMATION FROM A CUSTOMER ALLEGING AN ISSUE WITH A SOFTWARE UPDATE OCCURRED ON A TRILOGY EVO VENTILATOR. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. THE CUSTOMER STATES DURING A SOFTWARE UPDATE TO VERSION 1.06.15 ERROR CODES IN RELATION TO (SOFT POWER FAILURE AND HARD POWER FAILURE) WERE RECORDED IN THE DEVICE EVENT LOG AND THAT ALL THE SETTINGS WERE GONE, THE DEVICE ALARMED AND A RED SCREEN OCCURRED. THE DEVICE IS CURRENTLY UNDER INVESTIGATION. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24829550 ↗
• MalfunctionMar 30, 2026Circuit Failure; Electrical /Electronic Property Problem

  A TRILOGY EVO 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 A VENTILATOR INOPERATIVE ALARM WAS OBSERVED IN THE DEVICE'S DOWNLOADED EVENT LOG. THERE WAS NO DOCUMENTATION OF ANY COMPONENTS REPLACED OR RESOLUTION FOR THIS ISSUE. ADDITIONALLY, NOT RELATED TO THE REPORTABLE ISSUE, A SERVICE REQUIRED ALARM INDICATING THE DETACHABLE BATTERY FAILED WAS NOTED. THE DETACHABLE BATTERY WAS REPLACED TO ADDRESS THE ISSUE. FINAL TESTING WAS NOT DOCUMENTED. 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 AND ASSOCIATED MEDICAL DEVICE REPORTING A FOLLOW UP/SUPPLEMENTAL REPORT WILL BE COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24719408 ↗
• MalfunctionMar 24, 2026Circuit Failure; Electrical /Electronic Property Problem; No Device Output; Battery Problem

  FOLLOWING A SOFTWARE UPDATE, THE TRILOGY EVO IS NO LONGER RESPONDING, LEADING THE USER TO BE UNABLE TO ACCESS THE MENU. IN ADDITION, IT IS REPORTED THAT THE BATTERY ICON IS EMPTY EVEN THOUGH IT IS FULLY CHARGED. THERE WAS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS SPECIFIED BY THE PATIENT PHILIPS IS CURRENTLY INVESTIGATING THIS COMPLAINT. THE DEVICE HAS BEEN RECEIVED BY THE THIRD-PARTY SERVICE CENTER AND IS CURRENTLY AWAITING EVALUATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED AS DUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24674574 ↗
• MalfunctionMar 9, 2026Electrical /Electronic Property Problem; Battery Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR SERVICE REQUIRED ERROR CODE WAS FOUND DURING MAINTENANCE ON A TRILOGY EVO DEVICE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. THE TRILOGY EVO WAS BEING EVALUATED AT A THIRD-PARTY SERVICE CENTER FOR EVALUATION WHEN THE ISSUE OCCURRED ON THE DEVICE, DURING THE EVALUATION IT WAS NOTED THAT AN ERROR CODE, BATTERY NOT CHARGING FAULT, WAS OBSERVED ON THE DEVICE'S ERROR LOG. THE THIRD-PARTY SERVICE TECHNICIAN EVALUATED AND FOUND THE DETACHABLE BATTERY HAD CAUSED THE REPORTED ISSUE TO OCCUR ON THE DEVICE. IN CONCLUSION, THE DEVICE'S DETACHABLE BATTERY NEEDS REPLACED TO ADDRESS THE ISSUE. THE ROOT CAUSE IS CONFIRMED AT THIS TIME. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, THE AIR FOAM INLET FILTER, PARTICULATE FILTER, AND MUFFLER ASSEMBLY WERE REPLACED FOR PREVENTATIVE MAINTENANCE UNRELATED TO THE REPORTABLE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24547329 ↗
• MalfunctionFeb 25, 2026Electrical /Electronic Property Problem; Device Sensing Problem

  THE MANUFACTURER RECEIVED INFORMATION FROM THE CUSTOMER ALLEGING A PATIENT EXPERIENCED A VENTILATION INOPERATIVE STATE THAT HAD ALLEGEDLY OCCURRED WITH THE SAME ERRORS WHILE USING A TRILOGY EVO DEVICE. THE CUSTOMER ALLEGED THAT A MACHINE FLOW DRIFT HIGH, PRESSURE SENSOR MISMATCH ERROR CODES HAD OCCURRED ON THE DEVICE ALONG WITH TWO OTHER ERROR CODES, MOTOR CONTROLLER FORCE SHUTDOWN AND DRIFT DEBUG, FOR THIS DEVICE. THERE WAS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. THERE WAS NO MEDICAL INTERVENTION SPECIFIED BY THE CUSTOMER. PHILIPS IS CURRENTLY INVESTIGATING THIS COMPLAINT. THE DEVICE HAS BEEN RECEIVED BY THE THIRD-PARTY SERVICE CENTER AND IS CURRENTLY AWAITING EVALUATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED AS DUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24448348 ↗
• MalfunctionFeb 18, 2026Circuit Failure; Output Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE TRILOGY EVO EU IS NOT WORKING CORRECTLY AND DISPLAYING VENTILATOR SERVICE REQUIRED. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS NOT REPORTED TO BE IN PATIENT USE. DURING THE EVALUATION OF THE TRILOGY EVO EU DEVICE AT THE MANUFACTURE'S AUTHORIZED SERVICE CENTER, THE COMPLAINT WAS CONFIRMED. THE DEVICE POWERS ON WITHOUT PROBLEMS BUT HAS A FAULT IN THE SYSTEM PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) THAT CAUSES A LEAK, THE FAN DOES NOT BLOW PROPERLY AND HENCE THE SERVICE FAILURE. THE DEVICE'S SYSTEM BOARD WAS REPLACED TO ADDRESS THE ISSUE. FOLLOWING THE TESTING AND VERIFICATION PROCEDURE FOR THIS EQUIPMENT, THE DEVICE CONFIGURATION IS RESTORED TO FACTORY SETTINGS. ALL NECESSARY CHECKS HAVE BEEN CARRIED OUT TO CERTIFY THE RESTORATION TO THE CONDITIONS PRIOR TO THE BREAKDOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24379208 ↗
• MalfunctionFeb 10, 2026Electrical /Electronic Property Problem; Battery Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATION SERVICE REQUIRED ERROR CODE WAS FOUND DURING 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 RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR MAINTENANCE. DURING THE EVALUATION IT WAS NOTED THAT AN ERROR CODE, BATTERY NOT CHARGING (E-059), WAS OBSERVED ON THE DEVICE'S ERROR LOG. THE THIRD-PARTY SERVICE TECHNICIAN FURTHER EVALUATED AND DETERMINED THE DETACHABLE BATTERY HAD CAUSE THE ERROR CODE TO OCCUR ON THE DEVICE. IN CONCLUSION, THE DEVICE'S DETACHABLE BATTERY NEEDS REPLACED TO ADDRESS THE ISSUE. THE ROOT CAUSE IS CONFIRMED AT THIS TIME. 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 AND ASSOCIATED MEDICAL DEVICE REPORTING A SUPPLEMENTAL REPORT WILL BE COMPLETED. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, THE THIRD-PARTY SERVICE TECHNICIAN OBSERVED TWO ADDITIONAL ERROR CODES, AC DISCONNECTED (E-042) AND INTERNAL BATTERY IN USE (E-045), IN THE DEVICE'S ERROR LOG. THE THIRD-PARTY SERVICE TECHNICIAN EVALUATED BUT DID NOT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24308003 ↗
• MalfunctionDec 24, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE ALARM, RED SCREEN OCCURRED ON A TRILOGY EVO, EU DEVICE. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS NOT IN PATIENT USE. THE TRILOGY EVO, EU DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. 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 23888128 ↗
• MalfunctionDec 19, 2025Circuit Failure; Electrical /Electronic Property Problem; Incorrect, Inadequate or Imprecise Result or Readings; Circuit Failure; Electrical /Electronic Property Problem; Incorrect, Inadequate or Imprecise Result or Readings

  THE MANUFACTURER RECEIVED A REPORT THAT A TRILOGY EVO VENTILATOR WAS DELIVERING VERY SMALL PRESSURE REGARDLESS OF THE PRESSURE SETTINGS. REVIEW OF THE DEVICE ERROR LOG IDENTIFIED ¿VENTILATOR INOPERATIVE¿ ERRORS OCCURRED. NO FURTHER DETAILS WERE PROVIDED. NO PATIENT HARM OR SERIOUS INJURY WAS REPORTED. THE DEVICE WAS RETURNED FOR INVESTIGATION, BUT THE EVALUATION IS NOT YET COMPLETE. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23850828 ↗
• MalfunctionDec 11, 2025Power Problem; No Apparent Adverse Event; Power Problem; No Apparent Adverse Event

  THE MANUFACTURER RECEIVED A REPORT THAT A TRILOGY EVO VENTILATOR, "LOST THE POWER." NO FURTHER DETAILS WERE PROVIDED. NO PATIENT HARM OR SERIOUS INJURY WAS REPORTED. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23780055 ↗
• MalfunctionDec 11, 2025Incorrect, Inadequate or Imprecise Result or Readings; No Apparent Adverse Event; Incorrect, Inadequate or Imprecise Result or Readings; No Apparent Adverse Event

  THE MANUFACTURER RECEIVED A REPORT THAT A TRILOGY EVO VENTILATOR WAS PROVIDING AN INCORRECT PRESSURE. NO FURTHER DETAILS WERE PROVIDED. NO PATIENT HARM OR SERIOUS INJURY WAS REPORTED. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23778225 ↗
• MalfunctionNov 13, 2025Electrical /Electronic Property Problem; Failure to Calibrate; Electrical /Electronic Property Problem; Failure to Calibrate

  A TRILOGY EVO VENTILATOR WAS REPORTED TO HAVE ACTIVE EXHALATION CONTROL MODULE (AECM) TEST FAILURE. THERE WAS NO HARM OR INJURY REPORTED. ON DEVICE EVALUATION, IT WAS CONFIRMED THE VALVE, PROPORTIONAL (AECM) AND VALVE, THREE-WAY SOLENOID REQUIRED REPLACEMENT TO ADDRESS THE AECM TEST FAILURE. AFTER REPAIR, ALL NECESSARY CHECKS HAVE BEEN CARRIED OUT TO CERTIFY THE RESTORATION TO THE CONDITIONS PRIOR TO THE FAILURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23544467 ↗
• MalfunctionOct 16, 2025Decrease in Pressure; Loss of Threshold; Decrease in Pressure; Loss of Threshold

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING VENTILATOR SERVICE REQUIRED ALARM OCCURRED ON A TRILOGY EVO WHILE IN PATIENT USE. THERE WAS NO REPORT OF INJURY OR HARM. THE CUSTOMER STATES A TRILOGY EVO ERROR CODE INDICATING (THE DEVICE SOFTWARE HAS DETECTED A LARGE PRESSURE DROP BETWEEN THE MONITOR AND OUTLET PRESSURE SENSORS) WAS RECORDED IN THE EVENT LOG. THE DEVICE WAS SENT TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23308165 ↗
• MalfunctionOct 15, 2025Circuit Failure; Electrical /Electronic Property Problem; Circuit Failure; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR SERVICE REQUIRED ERROR CODE OCCURRED 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 ERROR CODE, BATTERY NOT CHARGING FAULT (E-059) WAS OBSERVED IN DEVICE'S ERROR LOG. THE THIRD-PARTY SERVICE TECHNICIAN DETERMINED THE SYSTEM PRINTED CIRCUIT ASSEMBLY (PCA) BOARD WAS CAUSING THIS TO OCCUR ON THE DEVICE. IN CONCLUSION, THE DEVICE'S SYSTEM PCA BOARD WAS REPLACED TO ADDRESS THE ISSUE. THE ROOT CAUSE IS CONFIRMED AT THIS TIME. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, THE AIR INLET FOAM FILTER WAS REPLACED FOR PREVENTATIVE MAINTENANCE UNRELATED TO THE REPORTABLE MALFUNCTION/ISSUE. THE DEVICE PASSED ALL FINAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23305893 ↗
• MalfunctionSep 4, 2025Circuit Failure; Power Problem; Circuit Failure; Power Problem

  THE MANUFACTURER WAS PREVIOUSLY NOTIFIED THAT A VENTILATOR REQUIRED MAINTENANCE AND CLEANING. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS NOT IN PATIENT USE. THE DEVICE WAS EVALUATED BY A THIRD-PARTY SERVICE CENTER. DURING THE EVALUATION A SERVICE REQUIRED ALARM INDICATING A POWER FAILURE OCCURRED. THE DEVICE'S SYSTEM BOARD WAS REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, NON-ACTIONABLE ERRORS WERE OBSERVED IN DEVICE'S DOWNLOADED EVENT LOG. THE MACHINE FLOW SENSOR WAS FOUND TO BE CONTAMINATED AND WAS REPLACED TO ADDRESS THE ISSUE. THE DEVICE'S AIR INLET FOAM FILTER WAS REPLACED PER PREVENTIVE MAINTENANCE PROTOCOL. THE DEVICE WAS TESTED AND PASSED ALL FINAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22963586 ↗
• MalfunctionAug 19, 2025Electrical /Electronic Property Problem; Failure to Calibrate; Electrical /Electronic Property Problem; Failure to Calibrate

  THE MANUFACTURER RECEIVED INFORMATION FROM A THIRD-PARTY DISTRIBUTOR THAT A TRILOGY EVO VENTILATOR IS NOT OPERATIVE. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. THE DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION. GOOD FAITH EFFORTS ARE ACTIVELY BEING MADE TO HAVE THE DEVICE RETURNED FOR EVALUATION. IF THE DEVICE IS RETURNED AND EVALUATED, A FOLLOW-UP REPORT WILL BE SUBMITTED WITH THE EVALUATION RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22841022 ↗