Trilogy Trilogy Evo Ventilator, IntlRecalls & reported problems

Summary

The FDA's MAUDE database contains 648 adverse event reports that list this exact device (DI 00606959051959), received between Sep 22, 2020 and Sep 30, 2026 — classified as 3 deaths, 8 injuries, 637 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (230 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. 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-0291-2025 · 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-1504-2024 · 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 ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 648 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Device Sensing Problem

  A Trilogy EVO device was returned to a third-party service center for service. No medical intervention was specified. The device was not reported to be in clinical use.During the evaluation, the error log was downloaded and reviewed. An E0384 (EVT_PRESS_SENSOR_MISMATCH) error was identified. The air pathway was inspected for environmental debris and contamination; none was found. The evaluation did not identify a specific cause for the E0384 error. The device subsequently passed performance verification following service.Additionally, the evaluation of the device data identified unrelated error codes. These error codes are consistent with normal device operation and expected use conditions and are not considered reportable under medical device reporting requirements. No evidence was identified to suggest that these error codes contributed to or caused the reported event. Preventive maintenance components, including the particulate filter, inlet foam filter, and muffler, were replaced as part of the four-year service. A missing filter cover was also identified during external inspection and replaced.Should further investigation provide new information that impacts the outcome of the

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948383 ↗
• MalfunctionSep 9, 2026Electrical /Electronic Property Problem; Battery Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50696469 ↗
• MalfunctionJun 29, 2026Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION THAT A TRILOGY EVO VENTILATOR WAS INOPERATIVE. THERE WAS NO PATIENT INVOLVEMENT, AND NO HARM OR INJURY REPORTED. 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 25654458 ↗
• MalfunctionJun 24, 2026Device Sensing Problem; Power Problem

  A TRILOGY EVO DEVICE WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER DUE TO A COMPLAINT OF NO AC POWER. NO PATIENT HARM OR INJURY WERE REPORTED. THE TRILOGY EVO DEVICE WAS RETURNED TO THE THIRD-PARTY SERVICE AND EVALUATED. IN THE PRELIMINARY IN PROCESS EVALUATION, THE COMPLAINT WAS CONFIRMED AND WAS FOUND TO BE DUE TO A DEFECTIVE POWER SUPPLY. IN ADDITION, AN ERROR CODE RELATED TO A DEFECT IN THE MACHINE FLOW SENSOR WAS ALSO DISCOVERED. IN CONCLUSION, THE MACHINE FLOW SENSOR AND POWER SUPPLY 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 25610489 ↗
• MalfunctionJun 24, 2026Electrical /Electronic Property Problem; Failure to Calibrate

  THE MANUFACTURER RECEIVED INFORMATION THAT A TRILOGY EVO VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION ASSOCIATED WITH A FIELD CHANGE ORDER. THERE WAS NO PATIENT INVOLVEMENT, AND NO HARM OR INJURY REPORTED. ON EVALUATION, THE DEVICE FAILED PNEUMATIC TESTING; THEREFORE, THE MACHINE FLOW SENSOR REQUIRES REPLACEMENT DUE TO (B)(4). ADDITIONAL FINDINGS NOT RELATED TO THE MALFUNCTION/ISSUE: NON-CRITICAL ERROR CODES 330 AND 361 INDICATE THE SYSTEM PRINTED CIRCUIT BOARD ASSEMBLY REQUIRES REPLACEMENT. NON-CRITICAL ERROR CODE 82 INDICATES THE BLOWER ASSEMBLY REQUIRES REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25610299 ↗
• MalfunctionJun 23, 2026Circuit Failure; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A TRILOGY EVO, INTERNATIONAL DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER DUE TO THE DEVICE DISPLAYING "VENTILATOR INOPERATIVE" AFTER THE SOFTWARE WAS UPDATED TO V1.06.15.00. DURING THE EVALUATION OF THE TRILOGY EVO, INTERNATIONAL DEVICE AT THE SERVICE CENTER, THE SERVICE TECHNICIAN DISCOVERED ERROR (ERROR CODE 156) IN THE DEVICE ERROR CODE LOG, AND THE SYSTEM PRINTED CIRCUIT ASSEMBLY (PCA) NEEDS TO BE REPLACED DUE TO THIS ERROR. ADDITIONALLY, THE INTERNAL BATTERY NEEDS TO BE REPLACED DUE TO PM ASSESSMENTS, AND THE AIR INLET FOAM FILTER, PARTICULATE FILTER, AND MUFFLER ASSEMBLY NEED TO BE REPLACED DUE TO 4-YEAR PM. THE IN-LINE FILTER AND IN-LINE FILTER PROX. ARE CONTAMINATED WITH DUST AND THE MACHINE FLOW SENSOR IS DAMAGED. THE DEVICE EVALUATION IS STILL IN PROCESS. IF ADDITIONAL INFORMATION IS PROVIDED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25596524 ↗
• MalfunctionJun 18, 2026Electrical /Electronic Property Problem

  HE 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 25549939 ↗
• 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 INCLUDING THE MACHINE FLOW SENSOR. PREVENTATIVE MAINTENANCE WITH REQUIRED COMPONENT REPLACEMENTS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25549574 ↗
• MalfunctionJun 15, 2026Display Difficult to Read

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE SCREEN WAS PARTIALLY ILLUMINATED WHILE PERFORMING PREVENTATIVE MAINTENANCE ON A TRILOGY EVO DEVICE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. DURING THE EVALUATION IT WAS NOTED THAT THE DEVICES DISPLAY HAD CAUSE THE SCREEN TO BE PARTIALLY ILLUMINATED ON THE DEVICE. IN CONCLUSION, THE DEVICE'S DISPLAY WAS REPLACED TO ADDRESS THE ISSUE. THE ROOT CAUSE IS CONFIRMED AT THIS TIME. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, THE INLINE PROXIMAL FILTER WAS REPLACED FOR CONTAMINATION UNRELATED TO THE REPORTABLE ISSUE. THE AIR INLET FOAM FILTER AND PARTICULATE FILTER WERE REPLACED FOR PREVENTATIVE MAINTENANCE UNRELATED TO THE REPO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25509132 ↗
• MalfunctionJun 4, 2026Circuit Failure; Electrical /Electronic Property Problem; No Tactile Prompts/Feedback

  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 INITIAL EVALUATION A VENTILATOR INOPERATIVE ALARM INDICATING A PRESSURE SENSOR FAILED WAS OBSERVED. THE DEVICE'S SYSTEM BOARD NEEDS TO BE REPLACED TO ADDRESS THE ISSUE. A SERVICE REQUIRED ALARM INDICATING A TOUCHSCREEN FAILURE WAS OBSERVED. THE DEVICE'S DISPLAY BOARD WAS REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, NOT RELATED TO THE REPORTABLE ISSUES, A MACHINE FLOW DRIFT LOG ONLY ALARM WAS OBSERVED. THE DEVICE'S MACHINE FLOW SENSOR WAS REPLACED TO ADDRESS THE ISSUE. AN OUTLET PRESSURE AND MONITOR PRESSURE RAILED ALARM WAS OBSERVED. THE SYSTEM BOARD REPLACEMENT WOULD ADDRESS THESE ISSUES. THESE ISSUES ALONE WOULD NOT AFFECT THE DEVICE'S ABILITY TO DELIVER THERAPY AS DESIGNED. 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 25398727 ↗
• MalfunctionJun 2, 2026Circuit Failure; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THAT A TRILOGY EVO INTERNATIONAL VENTILATOR WAS INOPERATIVE AND DISPLAYED AN ERROR CODE. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE EVENT. THE DEVICE WAS EVALUATED AT A THIRD-PARTY SERVICE CENTER. REVIEW OF THE DEVICE EVENT LOG IDENTIFIED A VENTILATOR INOPERATIVE CONDITION ASSOCIATED WITH ERROR CODE EVT_PRESS_SENSORS_FAILURE, INDICATING FAILURE OF BOTH THE OUTLET PRESSURE SENSOR AND MONITOR PRESSURE SENSOR. SERVICE PERSONNEL REPLACED THE SYSTEM PRINTED CIRCUIT ASSEMBLY (PCA), AFTER WHICH THE DEVICE RETURNED TO NORMAL OPERATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25364641 ↗
• MalfunctionJun 1, 2026Charging Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A TRILOGY EVO HAD A SERVICE REQUIRED ERROR IN THE MAIN SCREEN DUE TO ERROR LOGS. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. AN ERROR CODE RELATED TO THE CHARGING OF THE BATTERY WAS IN THE ERROR LOG. EVT_BATTERY_NOT_CHARGING_FAULT MEANS THE INTERNAL OR DETACHABLE LI-ION BATTERY IS NOT CHARGING DUE TO A HARDWARE FAULT FOR GREATER THAN OR EQUAL TO ONE MINUTE. ADDITIONALLY, NON-REPORTABLE ERROR CODES WERE FOUND IN THE ERROR LOG. EVT_BATT_SAFETY_STATUS MEANS ONE OR MORE SAFETY STATUS FLAGS HAVE BEEN SET ON A BATTERY. EVT_CHG_DEBUG IS A GENERIC CHARGER DEBUG MESSAGE. EVT_MACH_FLOW_DRIFT_LOG MEANS THE SENSOR THAT DRIFT WAS COMPLETED ON, OFFSET VALUE, PEAK TO PEAK VALUE, AND TEMPERATURE DURING DRIFT CALCULATION. THE MANUFACTURER'S INVESTIGATION IS ONGOING. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25351551 ↗
• MalfunctionMay 22, 2026Electrical /Electronic Property Problem

  A TRILOGY EVO, INTERNATIONAL DEVICE WAS REPORTED TO HAVE AN "INOPERATIVE" MESSAGE ON THE DISPLAY WHEN THE DEVICE WAS SWITCHED ON. THERE WAS NO ALLEGATION OF PATIENT HARM. 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 25257986 ↗
• MalfunctionMay 22, 2026Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THAT A VENTILATOR INOPERATIVE MESSAGE APPEARS ON THE DISPLAY AFTER TURNING ON A TRILOGY EVO DEVICE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. PHILIPS IS CURRENTLY INVESTIGATING THIS COMPLAINT; HOWEVER, THE DEVICE EXAMINATION HAS NOT BEGUN BECAUSE THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR INVESTIGATION. AS PART OF THE COMPLAINT HANDLING PROCESS, THE MANUFACTURER WILL ATTEMPT TO RETRIEVE THE DEVICE FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25256738 ↗
• MalfunctionMay 22, 2026Display or Visual Feedback Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A BROKE SCREEN OCCURRED ON A TRILOGY EVO VENTILATOR. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. THE TRILOGY EVO VENTILATOR WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR EVALUATION, AND THE CUSTOMER¿S COMPLAINT WAS CONFIRMED. DURING THE EVALUATION OF THE DEVICE AN ERROR CODE IN RELATION TO UI_BACKLIGHT_FAIL WAS RECORDED IN THE DEVICE EVENT LOG. IN CONCLUSION, THE DEVICE'S DISPLAY WAS REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, THE FIO2 SENSOR WAS TESTED AND FAILED THE TEST, THEN THE UNIT WAS TESTED WITH THE GOLD FIO2 SENSOR AND PASSED THE TEST UNRELATED TO THE REPORTABLE MALFUNCTION/ISSUE. THE FIO2 SENSOR WAS REPLACED TO ADDRESS THE ISSUE. ADDITIONAL COMPONENTS WERE REPLACED AS PART OF MAINTENANCE OF THE DEVICE OR DUE TO CONTAMINATION. THE SOFTWARE WAS UPGRADED. THIS DEVICE HAS BEEN SERVICED, INSPECTED, TESTED, MET ACCEPTANCE CRITERIA IN ACCORDANCE WITH ALL OF THE APPLICABLE CUSTOMER REQUIREMENTS AS DEFINED IN THE CONTRACTUAL AGREEMENT WITH PLEXUS. THE DEVICE HISTORY RECORD HAS BEEN REVIEWED AND APPROVED BY PLEXUS QUALITY ASSURANCE. THE DEVICE PASSED ALL FINAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25252254 ↗
• MalfunctionMay 21, 2026Adverse Event Without Identified Device or Use Problem; Audible Prompt/Feedback Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE ALARMS ON A TRILOGY EVO MECHANICAL VENTILATOR FAILED TO ACTIVATE WHILE THE DEVICE WAS CONNECTED TO A PATIENT DURING CLINICAL USE. THE CUSTOMER REQUESTED TECHNICAL INSPECTION OF THE DEVICE. THE PATIENT REPORTEDLY EXPIRED; HOWEVER, THE CAUSE OF DEATH WAS UNKNOWN AT THE TIME OF REPORTING, AND NO INFORMATION WAS PROVIDED TO ESTABLISH THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED DEATH. NO ADDITIONAL PATIENT IMPACT OR INTERVENTION INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT, AFTER GATHERING AND REVIEWING ALL RELEVANT AVAILABLE INFORMATION, THE CUSTOMER DETERMINED THE EVENT WAS NOT CAUSED BY EQUIPMENT FAILURE. THE CUSTOMER REQUESTED CONFIRMATION ON WHETHER FACTORY EVALUATION OF THE DEVICE WAS STILL REQUIRED OR WHETHER THE CASE COULD BE CLOSED BASED ON THE AVAILABLE INFORMATION. A REQUEST WAS MADE FOR THE DEVICE TO BE RETURNED FOR EVALUATION. PHILIPS HAS REQUESTED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT AND DEVICE PERFORMANCE. IF NEW RELEVANT INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Insufficient Information

  MAUDE report 25239748 ↗
• MalfunctionMay 14, 2026Electrical /Electronic Property Problem

  A TRILOGY EVO WAS RETURNED TO THE MANUFACTURER'S SERVICE CENTER DUE TO A SERVICE REQUIRED ALARM CONDITION OBSERVED. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION, THE CUSTOMER'S COMPLAINT WAS CONFIRMED. A SERVICE REQUIRED ALARM INDICATING A PRESSURE SENSOR MISMATCH WAS CONFIRMED. THE DEVICE'S MACHINE FLOW SENSOR WAS REPLACED TO ADDRESS THE ISSUE. THE DEVICE'S AIR INLET FILTER, IN-LINE FILTER, PROXIMAL FILTER AND MUFFLER ASSEMBLY WERE ALL REPLACED DUE TO DIRT CONTAMINATION. THIS WOULD NOT AFFECT THE DEVICE'S ABILITY TO DELIVER THERAPY AS DESIGNED. THE DEVICE WAS TESTED AND PASSED ALL FINAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25174837 ↗
• MalfunctionMay 14, 2026Erratic or Intermittent Display; Electrical /Electronic Property Problem

  A TRILOGY EVO, INTERNATIONAL WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION. NO PATIENT HARM OR INJURY WAS REPORTED. DURING THE EVALUATION, THE ERROR LOG WAS DOWNLOADED AND EVALUATED. A VENTILATOR INOPERATIVE ERROR EVT_COMMSFAIL_UI_TO_TPY (ERROR CODE 196) WAS FOUND IN THE DEVICE ERROR CODE LOG. THE DISPLAY WAS INTERMITTENTLY FLICKERING, AND THE DISPLAY WAS REPLACED TO RECTIFY THE ISSUE. ADDITIONALLY, THE EVALUATION OF THE DEVICE DATA IDENTIFIED UNRELATED ERROR CODES. THESE ERROR CODES ARE CONSISTENT WITH NORMAL DEVICE OPERATION AND EXPECTED USE CONDITIONS AND ARE NOT CONSIDERED REPORTABLE UNDER MEDICAL DEVICE REPORTING REQUIREMENTS. NO EVIDENCE WAS IDENTIFIED TO SUGGEST THAT THESE ERROR CODES CONTRIBUTED TO OR CAUSED THE REPORTED EVENT. A 4-YEAR SERVICE WAS COMPLETED, AND NO COSMETIC DAMAGE WAS FOUND DURING INTERNAL/EXTERNAL INSPECTION. THE SERVICE TECHNICIAN ALSO NOTED THAT A "BENCH RUN DEVICE IN WITH NO ALARMS SOUNDING". AFTER THE EVALUATION AND REPAIR WERE COMPLETE, THE DEVICE WAS TESTED AND ALL TESTING PASSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25172363 ↗
• MalfunctionMay 12, 2026Electrical /Electronic Property Problem; Grounding Malfunction; Device Contamination with Chemical or Other Material

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR SERVICE REQUIRED ERROR CODE WAS FOUND ON A TRILOGY EVO DEVICE. 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, PRESSURE SENSOR MISMATCH, WAS OBSERVED ON THE DEVICE'S ERROR LOG. THE THIRD-PARTY SERVICE TECHNICIAN FURTHER EVALUATED AND DETERMINED THERE WAS CONTAMINATION ON THE MACHINE FLOW SENSOR AND PROXIMAL FILTERS HAD CAUSED THE VENTILATOR SERVICE REQUIRED ERROR CODE TO OCCUR ON THE DEVICE. IN CONCLUSION, THE DEVICE'S MACHINE FLOW SENSOR AND PROXIMAL FILTERS WERE 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, MUFFLER, INTERNAL BATTERY, AND DETACHABLE BATTERY WERE REPLACED FOR PREVENTATIVE MAINTENANCE UNRELATED TO THE REPORTABLE ISSUE. THE DEVICE PASSED ALL FINAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25153890 ↗
• MalfunctionApr 21, 2026Circuit Failure; Electrical /Electronic Property Problem; Battery Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATION 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 RETURNED TO THE MANUFACTURER SERVICE CENTER FOR EVALUATION, AND THE CUSTOMER¿S COMPLAINT WAS CONFIRMED. DURING THE EVALUATION IT WAS NOTED THAT AN ERROR CODE, BATTERY NOT CHARGING FAULT, WAS OBSERVED ON THE DEVICE'S ERROR LOG. THE SERVICE TECHNICIAN FURTHER EVALUATED AND DETERMINED THE SYSTEM PRINTED CIRCUIT ASSEMBLY (PCA) AND BATTERY HAD CAUSED THIS REPORTABLE ISSUE TO OCCUR ON THE DEVICE. IN CONCLUSION, THE DEVICE'S SYSTEM PCA AND BATTERY WERE REPLACED TO ADDRESS THE ISSUE. THE ROOT CAUSE IS CONFIRMED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24942511 ↗
• MalfunctionApr 21, 2026Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A SERVICE REQUIRED ALARM OCCURRED ON A TRILOGY EVO VENTILATOR. THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. THERE WAS NO REPORT OF HARM OR INJURY. THE TRILOGY EVO WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR EVALUATION, AND THE CUSTOMERS COMPLAINT WAS NOT CONFIRMED. DURING THE EVALUATION IT WAS NOTED THAT AN ERROR CODE INDICTING "THE DEVICE SOFTWARE HAS DETECTED A LARGE PRESSURE DROP BETWEEN THE MONITOR AND OUTLET PRESSURE SENSORS" WAS RECORDED IN THE DEVICE EVENT LOG BUT DID NOT REOCCUR AND WAS NOT DUPLICATED AT SERVICE. THE AIR PATHWAY WAS INSPECTED, AND NO ENVIRONMENTAL DEBRIS WAS FOUND, HOWEVER THE DEVICE WAS CONTAMINATED WITH TOBACCO ODOR. IN CONCLUSION, THE COMPLETE AIR PATHWAY COMPONENTS WOULD NEED TO BE REPLACED TO RESOLVE THE ISSUE OF TOBACCO CONTAMINATION, OR THE DEVICE WOULD NEED TO BE SCRAPPED. THE SERVICE CENTER IS AWAITING THE CUSTOMERS RESPONSE ON HOW TO PROCEED. UNRELATED TO THE REPORTABLE MALFUNCTION, DURING THE EVALUATION AN ERROR CODE IN RELATION TO "ERASE OR WRITE A CALIBRATION DATA TABLE" WAS RECORDED IN THE DEVICE EVENT LOG THEREFORE THE SOFTWARE WAS UPGRADED TO VERSION 1.06.15.00 TO ADD

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24936276 ↗
• MalfunctionApr 16, 2026Device Sensing Problem

  A TRILOGY EVO DEVICE WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR SERVICE. 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. DURING THE EVALUATION, IT WAS NOTED THAT AN ERROR SIGNALED A PRESSURE MISMATCH IN THE FLOW SENSOR DUE TO DUST CONTAMINATION. IN CONCLUSION, THE DEVICE'S 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 24903047 ↗
• MalfunctionApr 15, 2026Circuit Failure; Electrical /Electronic Property Problem

  A TRILOGY EVO DEVICE WAS RETURNED TO A THIRD PARTY SERVICE CENTER FOR SERVICE AND WAS MISSING A SERVICE KIT. IT IS NOTED THAT THE MISSING SERVICE KIT WAS THEN RESOLVED. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. DURING EVALUATION OF THE DEVICE AT THE THIRD PARTY SERVICE CENTER, A VENTILATOR INOPERATIVE ERROR CODE RELATING TO 'NVDATA_CORRUPT' WAS FOUND IN THE DEVICE'S ERROR LOG. THE SERVICE TECHNICIAN STATES THAT THE SYSTEM PRINTED CIRCUIT ASSEMBLY (PCA) BOARD NEEDS TO BE REPLACED TO RESOLVE THE ERROR. ADDITIONALLY, A NOT REPORTABLE EVENT ERROR RELATING TO 'MCL_FOC_SHUTDOWN' WAS ALSO FOUND IN THE DEVICE'S ERROR LOG. THE SERVICE TECHNICIAN STATES THAT THE BLOWER NEEDS TO BE REPLACED TO RESOLVE THE ERROR. PREVENTATIVE MAINTENANCE WAS PERFORMED AND THE AIR INLET FOAM FILTER, PARTICULATE FILTER, AND MUFFLER ASSEMBLY WERE REPLACED. THE IN-LINE FILTER PROX WAS CONTAMINATED WITH DUST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24888937 ↗
• MalfunctionApr 15, 2026Electrical /Electronic Property Problem; Device Sensing Problem

  THE MANUFACTURER RECEIVED A CUSTOMER REPORT INDICATING THAT A "VENTILATOR SERVICE REQUIRED" ALARM OCCURRED ON A TRILOGY EVO VENTILATOR. THE DEVICE WAS REPLACED. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. THE VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. DURING TESTING, THE REPORTED ISSUE WAS NOT REPRODUCED; HOWEVER, REVIEW OF THE DEVICE LOG FILES CONFIRMED THE OCCURRENCE OF A "VENTILATOR SERVICE REQUIRED" ALARM. THE LOGS INDICATED THAT THE DEVICE SOFTWARE DETECTED A LARGE PRESSURE DROP BETWEEN THE MONITOR AND OUTLET PRESSURE SENSORS. INTERNAL INSPECTION IDENTIFIED CONTAMINATION OF THE FLOW SENSOR. AS PART OF SERVICE AND REFURBISHMENT, MULTIPLE COMPONENTS WERE REPLACED, INCLUDING THE SYSTEM PRINTED CIRCUIT ASSEMBLY (PCA), BLOWER ASSEMBLY, FLOW SENSOR, 3-WAY SOLENOID VALVE, PROPORTIONAL VALVE, LOW FLOW O2 TUBING, BLOWER CHASSIS PLATE, BLOWER CAP, OUTLET SIDE PANEL, BLOWER MOUNT, BLOWER BELLOW SEAL, FIO2 HOUSING, DUAL LIMB CUP, FILTER COVER, MUFFLER ASSEMBLY, TUBING-BLOWER CHASSIS, TUBING FIO2, LOW FLOW O2 CONNECTOR, TUBING-SYSTEM PCA. DURING FUNCTIONAL TESTING OF THE DEVICE, THE UNIT FAILED THE FIO2 SENSOR RECEPTACLE VERIFICATION: ENERGIZ

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24884322 ↗
• MalfunctionApr 11, 2026Battery Problem; Device Sensing Problem

  A TRILOGY EVO DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THE DEVICE WAS NOT REPORTED TO BE IN CLINICAL USE. THE TRILOGY EVO VENTILATOR WAS RETURNED TO THE THIRD PARTY FOR SERVICE. DURING THE EVALUATION, AN ERROR CODE RELATED TO A FAILURE TO CHARGE THE BATTERY WAS NOTED. ADDITIONALLY, A VENTILATOR INOPERATIVE CODE RELATED TO A FAILURE IN THE FLOW SENSOR WAS OBSERVED. THE INTERNAL BATTERY, CIRCUIT BOARD, AND FLOW SENSOR NEED 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 24847594 ↗