Trilogy Evo FR2110X14BRecalls & reported problems

Summary

The FDA's MAUDE database contains 77 adverse event reports that list this exact device (DI 00606959055506), received between Jan 8, 2021 and Aug 25, 2026 — classified as 1 injury, 76 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (28 reports).

5 FDA recall records name this device's identifier, 5 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 ↗

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-1649-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 77 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2026Circuit Failure; Electrical /Electronic Property Problem; Mechanical Problem; Battery Problem; Device Sensing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50434461 ↗
• MalfunctionJun 30, 2026Electrical /Electronic Property Problem; Device Sensing Problem

  THE MANUFACTURER RECEIVED A REPORT THAT A TRILOGY EVO VENTILATOR REQUIRED MAINTENANCE. NO PATIENT HARM OR INJURY WAS REPORTED. THE DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION. THE DEVICE LOG FILES WERE SUCCESSFULLY DOWNLOADED AND REVIEWED. LOG ANALYSIS CONFIRMED THE OCCURRENCE OF A "VENTILATOR SERVICE REQUIRED" ERROR GENERATED WHEN THE DEVICE SOFTWARE DETECTED A MACHINE FLOW SENSOR DRIFT EXCEEDING 0.2 SLPM. REPLACEMENT OF THE MACHINE FLOW SENSOR WAS DETERMINED TO BE NECESSARY TO CORRECT THE REPORTED ISSUE. ADDITIONALLY, FINDINGS UNRELATED TO THE REPORTED MALFUNCTION WERE IDENTIFIED. THE BULK CAPACITOR REQUIRES REPLACEMENT DUE TO AN ALARM INDICATING THAT THE VOLTAGE ON THE MOTOR¿S BULK CAPACITOR EXCEEDED 47.5V FOR A PERIOD OF TIME. IN ADDITION, REPLACEMENT OF THE SYSTEM PRINTED CIRCUIT ASSEMBLY (PCA) WAS RECOMMENDED BASED ON AN ERROR INDICATING THAT THE SENSOR OFFSET DURING DRIFT CALCULATION WAS TOO HIGH. THE PROPORTIONAL VALVE (AECM) CABLE WAS FOUND TO BE DAMAGED, AND THE CONNECTOR COVER WAS MISSING. AS PART OF ROUTINE PREVENTIVE MAINTENANCE, THE AIR INLET FOAM FILTER, MUFFLER, AND PARTICULATE FILTER NEED TO BE REPLACED. IN ADDITION, A PREVENTIVE MAINTENANCE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25668022 ↗
• MalfunctionJun 26, 2026Electrical /Electronic Property Problem; Device Sensing Problem

  THE TRILOGY EVO VENTILATOR WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR PREVENTATIVE MAINTENANCE. THE DEVICE WAS NOT REPORTED TO BE IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. DURING THE EVALUATION OF THE DEVICE A VENTILATOR INOPERATIVE CONDITION WAS OBSERVED IN THE DEVICE EVENT LOG. ERROR CODES IN RELATION TO (MACHINE FLOW SENSOR RAILED TO MAXIMUM NEGATIVE VALUE, MACHINE FLOW SENSOR COMMUNICATION CEASED, AND THE SENSOR IS STUCK AT SAME VALUE, SOFT_POWER_FAIL AND THE DEVICE SOFTWARE HAS DETECTED A LARGE PRESSURE DROP BETWEEN THE MONITOR AND OUTLET PRESSURE SENSORS (I.E. ACROSS THE MACHINE FLOW SENSOR) WAS OBSERVED. IN CONCLUSION THE MACHINE FLOW SENSOR WAS REPLACED TO ADDRESS THE ISSUES. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, THE SYSTEM BOARD AND BLOWER WERE REPLACED TO ADDRESS ERROR CODES IN RELATION TO MCL_FOC_SHUTDOWN AND AMBIENT LIGHT UNRELATED TO THE REPORTABLE MALFUNCTION/ISSUE. IN ADDITION, COMPONENTS WERE REPLACED AS PART OF MAINTENANCE OF THE DEVICE OR CONTAMINATION. 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 PLEXU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25638926 ↗
• MalfunctionJun 26, 2026Battery Problem

  THE TRILOGY EVO VENTILATOR WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR PREVENTATIVE MAINTENANCE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. DURING THE EVALUATION OF THE DEVICE ERROR CODES IN RELATION TO (THE INTERNAL OR DETACHABLE LI-ION BATTERY IS NOT CHARGING DUE TO A HARDWARE FAULT FOR GREATER THEN 1 MINUTE, SOFT_POWER_FAIL AND THE INTERNAL LI-ION BATTERY IS DEPLETED) WERE OBSERVED IN THE DEVICE EVENT LOG. IN CONCLUSION THE DETACHABLE BATTERY WAS REPLACED TO RESOLVE THE ISSUES. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, COMPONENTS WERE REPLACED AS PART OF MAINTENANCE OF THE DEVICE. THE SOFTWARE WAS UPGRADED TO VERSION 1.06.15.00. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25636166 ↗
• MalfunctionMay 21, 2026Circuit Failure; Display or Visual Feedback Problem

  THE TRILOGY EVO VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR PREVENTATIVE MAINTENANCE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. DURING THE EVALUATION AN ERROR CODE IN RELATION TO UI_BACKLIGHT_FAIL WAS RECORDED IN THE DEVICE EVENT LOG. IN CONCLUSION THE DISPLAY BOARD WAS REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, THE MACHINE FLOW SENSOR WAS REPLACED DUE TO AN ERROR CODE IN RELATION TO MACH_FLOW_DRIFT_LOG UNRELATED TO THE REPORTED MALFUNCTION. ADDITIONAL COMPONENTS WERE REPLACED AS PART OF MAINTENANCE OF THE DEVICE. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25239248 ↗
• MalfunctionMay 14, 2026Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED A REPORT THAT A TRILOGY EVO VENTILATOR WAS RETURNED FOR MAINTENANCE SERVICE. THERE WERE NO REPORTS OR ALLEGATIONS OF PATIENT HARM OR INJURY. THE DEVICE WAS NOT REPORTED TO BE IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT A THIRD-PARTY SERVICE CENTER, THE DEVICE LOG FILES WERE SUCCESSFULLY DOWNLOADED AND REVIEWED IN FULL. A ¿VENT INOP¿ ALARM WAS IDENTIFIED, INDICATING THAT THE THERAPY CPU REMAINED IN BOOT MONITOR SOFTWARE. THE AVAILABLE SERVICE DOCUMENTATION DID NOT SPECIFY THAT ANY COMPONENTS REQUIRED REPLACEMENT TO RESOLVE THE ISSUE. NO ADDITIONAL ACTIONABLE ERROR CODES WERE IDENTIFIED. DUE TO THE 4-YEAR PREVENTIVE MAINTENANCE, THE AIR INLET FOAM FILTER, PARTICULATE FILTER AND MUFFLER WERE REPLACED. THE DISPLAY PCA WAS REPORTED TO BE DEFECTIVE DUE TO A FAULTY USB INLET PORT. THERE WAS NO INDICATION THAT THE DISPLAY MALFUNCTIONED IN A WAY THAT PREVENTED IT FROM BEING READ OR USED. THE CUSTOMER COMPLAINT WAS CONFIRMED. THE DEVICE HAS BEEN SERVICED, INSPECTED, TESTED, AND MET ACCEPTANCE CRITERIA IN ACCORDANCE WITH ALL OF THE APPLICABLE CUSTOMER REQUIREMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25173467 ↗
• MalfunctionMay 6, 2026Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED A REPORT THAT A TRILOGY EVO VENTILATOR WAS RETURNED FOR PREVENTIVE MAINTENANCE. NO PATIENT INJURY OR SERIOUS HARM WAS REPORTED. THE VENTILATOR WAS EVALUATED AT A THIRD-PARTY SERVICE CENTER. THE DEVICE LOG FILES WERE SUCCESSFULLY DOWNLOADED AND REVIEWED IN FULL. A ¿VENTILATOR SERVICE REQUIRED¿ ALARM WAS IDENTIFIED, ASSOCIATED WITH FAILURE OF THE INTERNAL BATTERY SYSTEM. THIS CONDITION MAY RESULT FROM THE BATTERY NOT BEING DETECTED, A FAILURE OF THE SYSTEM PRINTED CIRCUIT ASSEMBLY (PCA) AS INDICATED BY TERMINAL VOLTAGE, WAKE VOLTAGE, OR SMBUS COMMUNICATION ERRORS, OR AN INTERNAL BATTERY FAILURE. THE LOGS ALSO IDENTIFIED AN ERROR INDICATING THAT VBUS DROPPED BELOW 8.000V. THIS CONDITION MAY BE ASSOCIATED WITH DEPLETION OF ALL AVAILABLE POWER SOURCES, A FAULT IN THE ACTIVE POWER SOURCE, OR A POWER PATH CIRCUIT MALFUNCTION. AVAILABLE SERVICE DOCUMENTATION DID NOT INDICATE THAT ANY COMPONENT REPLACEMENTS WERE REQUIRED TO RESOLVE THE REPORTED ISSUE. NO ADDITIONAL ACTIONABLE ERROR CODES WERE IDENTIFIED. ADDITIONALLY, UNRELATED TO THE REPORTED MALFUNCTION, THE INLINE FILTER WAS FOUND TO BE CONTAMINATED WITH DUST. AS PART OF PREVENTIVE MAINTENANCE, THE AIR FOAM INLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25095917 ↗
• MalfunctionMay 1, 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. THE THIRD-PARTY SERVICE CENTER COMPLETION EVALUATION STATED REVIEW OF THE DEVICE'S DOWNLOADED DEVICE ERROR CODES REVEALED RECORD OF VENTILATOR INOPERATIVE ERROR CODE E-196 WHICH INDICATES RIPC (ROUTING INFORMATION PROTOCOL) COMMUNICATION FAILURE BETWEEN THE THERAPY AND USER INTERFACE (UI) CENTRAL PROCESSING UNITS (CPUS). SERVICE INDICATED THAT THE ERROR CODE NOTED DOES NOT REQUIRE CORRECTIVE ACTIONS. ADDITIONAL FINDINGS NOT RELATED TO THE MALFUNCTION/ISSUE: REPLACEMENT OF THE MACHINE FLOW SENSOR AND ONE IN-LINE PROXIMAL FILTER DUE TO CONTAMINATION. COMPONENTS THAT REQUIRED REPLACEMENT AS PART OF THE FOUR-YEAR PREVENTATIVE MAINTENANCE SCHEDULE WERE REPLACED. SOFTWARE VERSION HAS BEEN UPGRADED TO 1.06.15.00. THIS DEVICE HAS BEEN SERVICED, INSPECTED, TESTED, MET ACCEPTANCE CRITERIA IN ACCORDANCE WITH ALL OF THE APPLICABLE CUSTOMER REQUIREMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25056405 ↗
• MalfunctionApr 30, 2026Device Sensing Problem

  A TRILOGY EVO 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 A PRESSURE MISMATCH ALARM OCCURRED IN THE EVENT HISTORY LOG. IN CONCLUSION, THE DEVICE'S MACHINE FLOW SENSOR WAS REPLACED TO ADDRESS THE ISSUE. THE DEVICE WAS TESTED AND PASSED ALL FINAL TESTING. 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 25041922 ↗
• MalfunctionApr 29, 2026Electrical /Electronic Property Problem; Device Sensing Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A FAN ISSUE 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. DURING THE EVALUATION AN ERROR CODE IN RELATION TO MACH_FLOW_DRIFT_HIGH WAS RECORDED IN THE DEVICE EVENT LOG. IN CONCLUSION, THE DEVICE'S MACHINE FLOW SENSOR NEEDS TO BE REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, ERROR CODES IN RELATION TO MCL_FOC_SHUTDOWN AND DRIFT_DEBUG WERE RECORDED IN THE DEVICE EVENT LOG THEREFORE THE BLOWER AND SYSTEM BOARD NEED TO BE REPLACED TO ADDRESS THE ISSUES UNRELATED TO THE REPORTABLE MALFUNCTION/ISSUE. A 4-YEAR PREVENTATIVE MAINTENANCE IS REQUIRED FOR THE REPLACEMENT OF THE AIR INLET FOAM FILTER, PARTICULATE FILTER AND MUFFLER ASSEMBLY. THE 2 IN-LINE FILTER PROX AND TUBING LOW FLOW ARE CONTAMINATED AND REQUIRES REPLACEMENT. PHILIPS IS CURRENTLY INVESTIGATING THIS COMPLAINT. THE DEVICE HAS BEEN RECEIVED BY THE THIRD-PARTY SERVICE CENTER, AND THE EVALUATION IS CURRENTLY IN PROCESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED AS DUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25025728 ↗
• MalfunctionApr 10, 2026Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN EVENT POWER VBUS DROPPED ERROR CODE WAS FOUND 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 BEING EVALUATED AT A THIRD-PARTY SERVICE CENTER WHEN THE REPORTED EVENT HAD OCCURRED ON THE DEVICE. DURING THE EVALUATION IT WAS NOTED THAT THE THIRD-PARTY SERVICE TECHNICIAN PROVIDED NO DOCUMENTATION STATED ON A ROOT CAUSE AND/OR ANY COMPONENT REPLACEMENT TO RESOLVE THE EVENT POWER VBUS DROPPED ERROR CODE. THE DEVICE WILL BE SCRAPPED AT THE CUSTOMER'S REQUEST; THEREFORE, NO ADDITIONAL REPAIR INFORMATION WAS PROVIDED. 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 AIR FOAM INLET FILTER AND PARTICULATE FILTER NEEDS 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 24839832 ↗
• MalfunctionMar 30, 2026Circuit Failure; Display or Visual Feedback Problem; Electrical /Electronic Property Problem; Battery Problem

  THE MANUFACTURER RECEIVED A REPORT INDICATING A CUSTOMER WAS UNABLE TO UPDATE OR ACCESS THE CLINIC MENU ON A TRILOGY EVO VENTILATOR. THERE WAS NO REPORT OF PATIENT HARM OR INJURY ASSOCIATED WITH THIS ISSUE. THE DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR INVESTIGATION, BUT THE EVALUATION IS NOT YET COMPLETE. 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 24714608 ↗
• MalfunctionMar 13, 2026Circuit Failure; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATION INOPERATIVE ERROR CODE WAS OBSERVED ON THE DEVICE'S ERROR LOG DURING A FOUR-YEAR PREVENTATIVE MAINTENANCE SERVICE WAS BEING PERFORMED ON THE TRILOGY EVO DEVICE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. THE TRILOGY EVO DEVICE WAS HAVING A FOUR-YEAR PREVENTATIVE MAINTENANCE SERVICE BEING PERFORMED BY THE THIRD-PARTY SERVICE CENTER WHEN THE REPORTED ISSUE HAD OCCURRED ON THE DEVICE. DURING THE EVALUATION, IT WAS NOTED THAT A VENTILATOR INOPERATIVE ERROR CODE, THERAPY HELD IN BOOT MONITOR, WAS OBSERVED ON THE DEVICE'S ERROR LOG FOR THIS DEVICE. THE THIRD-PARTY SERVICE TECHNICIAN EVALUATED AND DETERMINED THE SYSTEM PRINTED CIRCUIT ASSEMBLY (PCA) HAD CAUSED THE ERROR CODE TO OCCUR ON THE DEVICE. THE THIRD-PARTY SERVICE TECHNICIAN OBSERVED ANOTHER ERROR CODE, INTERNAL BATTERY NOT DETECTED, IN THE DEVICE'S ERROR LOG. THE THIRD-PARTY SERVICE TECHNICIAN EVALUATED FOR THIS ERROR CODE AND DETERMINED THAT THE SYSTEM PCA HAD CAUSED THIS TO OCCUR ON THE DEVICE. IN CONCLUSION, THE SYSTEM PCA NEEDS REPLACED TO ADDRESS THIS ISSUE. A FINAL REPORT IS BEING SUBMITTED. IF NEW INFORMATION BECOMES AVAILABLE FOLLOWING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24590332 ↗
• MalfunctionMar 6, 2026Electrical /Electronic Property Problem; Device Sensing Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A FAN WAS NOT OPERATING ON A TRILOGY EVO DEVICE. NO MEDICAL INTERVENTION WAS SPECIFIED. THE DEVICE WAS NOT REPORTED TO BE IN CLINICAL USE AT THE TIME OF THE ALLEGATION. 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, A VENTILATOR INOPERATIVE OCCURRED DUE TO THE MACHINE FLOW SENSOR DRIFTING ABOVE SPECIFICATIONS. IN CONCLUSION, THE DEVICE'S FLOW SENSOR NEEDS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24536091 ↗
• MalfunctionMar 2, 2026Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING MANDATORY MAINTENANCE TO BE CARRIED OUT. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. DURING THE EVALUATION OF THE DEVICE AT THIRD-PARTY SERVICE CENTER, VENTILATOR INOPERATIVE ERROR CODES WERE FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. EVT_MACH_FLOW_DRIFT_HIGH MEANS THE MACHINE FLOW SENSOR DRIFT ABOVE THE SPECIFICATION (>0.2LPM) AND EVT_TPY_HELD_IN_BM MEANS THE THERAPY CPU IS STILL RUNNING IN BOOT MONITOR SOFTWARE. THE DEVICE EVALUATION DOES NOT IDENTIFY ANY SPECIFIC COMPONENT MALFUNCTION THAT WOULD NEED TO BE REPLACED TO RESOLVE THE REPORTED ERROR CODES. NECESSARY PARTS WERE REPLACED TO FULFILL PREVENTIVE MAINTENANCE, AND THE DEVICE PASSED ALL TESTING. ADDITIONALLY, UNRELATED TO THE VENTILATOR INOPERATIVE ERROR CODES, DURING THE EVALUATION OF THE DEVICE AT THIRD-PARTY SERVICE CENTER, ERROR CODES RELATED TO THE MOTOR DRIVE AND MOTOR FLUX MEASUREMENT WERE NOTED. EVT_DRV8301_OCTW_ACTIVE_LOW MEANS THE MOTOR DRIVER IC HAS DETECTED AN OVER-CURRENT OR OVER-TEMPERATURE CONDITION. EVT_MOTOR_FLUX_MAGNITUDE_RUNTIME MEANS THE MOTOR FLUX MEASUREMENT IS EITHER TOO HIGH OR TOO LOW WHEN THE MOTOR IS IN THE RUN STATE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24484371 ↗
• MalfunctionFeb 24, 2026Circuit Failure; No Device Output

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A TRILOGY EVO WAS UNABLE TO FUNCTION. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION. THE EVALUATION HAS NOT YET BEEN COMPLETED. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. IF ANY ADDITIONAL INFORMATION IS RECEIVED ONCE THE INVESTIGATION IS COMPLETE, A FOLLOW-UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24428385 ↗
• MalfunctionJan 26, 2026Display or Visual Feedback Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATION SERVICE REQUIRED ERROR CODE WAS FOUND 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 BEING EVALUATED DURING PREVENTATIVE MAINTENANCE AT THE THIRD-PARTY SERVICE CENTER. DURING THE EVALUATION IT WAS NOTED THAT THE ERROR CODE, USER INTERFACE BACKLIGHT FAILED (E-0304), WAS OBSERVED ON THE DEVICE'S ERROR LOG. THE THIRD-PARTY SERVICE TECHNICIAN FURTHER EVALUATED AND DETERMINED THE DISPLAY HAD CAUSED THE ERROR CODE TO OCCUR 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, ANOTHER ERROR CODE, CALIBRATION DATA EVENT (E-0107), WAS OBSERVED ON THE DEVICE'S ERROR LOG AND THE SOFTWARE WAS RE-INSTALLED ON THE DEVICE TO ADDRESS THE ISSUE. THIS WAS UNRELATED TO THE REPORTABLE EVENT. THE PROXIMAL FILTER WAS REPLACED FOR CONTAMINATION UNRELATED TO THE REPORTABLE ISSUE. THE AIR FOAM FILTER, MUFFLER, AND PARTICULATE FILTER WERE REPLACED FOR PREVENTATIVE MAINTENANCE UNRELATED TO THE REPORTABLE ISSUE. THE DEVICE P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24179116 ↗
• MalfunctionDec 10, 2025Battery Problem; Power Problem; Battery Problem; Power 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 THIRD-PARTY SERVICE CENTER, A "SERVICE REQUIRED" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S POWER SUPPLY HAS TO BE REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, AIR INLET FOAM FILTER WILL BE REPLACED DUE TO PREVENTIVE MAINTENANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23774663 ↗
• MalfunctionDec 9, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A DAMAGED SCREEN 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 INLINE FILTER WAS REPLACED FOR CONTAMINATION UNRELATED TO THE REPORTABLE ISSUE. THE AIR FOAM INLET FILTER, PARTICULATE FILTER, AND MUFFLER 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 23760777 ↗
• MalfunctionNov 21, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A DAMAGED SCREEN WAS FOUND 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 EVALUATION, AND THE CUSTOMER¿S COMPLAINT WAS CONFIRMED. DURING THE EVALUATION, THE THIRD-PARTY SERVICE TECHNICIAN PROVIDED NO FINDINGS ON THE CAUSE OF THE DAMAGE DISPLAY THAT WAS ON THIS DEVICE. IN CONCLUSION, THE DEVICE'S DISPLAY WAS REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, THE MUFFLER ASSEMBLY, PARTICULATE FILTER, AND AIR INLET FOAM FILTER WERE REPLACED FOR PREVENTATIVE MAINTENANCE UNRELATED TO THE REPORTABLE ISSUE. THE VANITY COVER WAS REPLACED DUE TO THE ALARM AUDIO PAUSE BUTTON MISSING ON THE DEVICE. THIS WAS UNRELATED TO THE REPORTABLE ISSUE. THE INTERNAL BATTERY DOOR AND BLOWER CHASSIS WERE REPLACED DUE TO PHYSICAL DAMAGE UNRELATED TO THE REPORTABLE ISSUE. THE MACHINE FLOW SENSOR WAS REPLACED FOR CONTAMINATION UNRELATED TO THE REPORTABLE ISSUE. THE DEVICE PASSED ALL FINAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23621907 ↗
• MalfunctionNov 18, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION THE TRILOGY EVO VENTILATOR WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR THE REPORT OF PREVENTATIVE MAINTENANCE REQUIRED. THERE NO HARM OR INJURY REPORTED. ON EVALUATION, ERROR CODE E-133 WAS NOTED IN THE ERROR LOG INDICATING THE ACTIVE EXHALATION VALVE (AEV) WAS STUCK CLOSED. THIS ISSUE COULD AFFECT THE EXTERNAL AEV IN THE CIRCUIT (DIAPHRAGM). THE ACTIVE EXHALATION CONTROL MODULE (AECM) WAS REPLACED TO ADDRESS THIS ISSUE.. AS PART OF MAINTENANCE, THE AIR INLET FOAM FILTER, MUFFLER, AND PARTICULATE FILTER WERE REPLACED TO PREVENT FAILURE. ADDITIONAL FINDINGS NOT RELATED TO THE MALFUNCTION/ISSUE: ONE IN-LINE FILTER, PROXIMAL REQUIRED REPLACEMENT DUE TO CONTAMINATION. THIS DEVICE HAS BEEN SERVICED, INSPECTED, TESTED, MET ACCEPTANCE CRITERIA IN ACCORDANCE WITH ALL OF THE APPLICABLE CUSTOMER REQUIREMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23580063 ↗
• MalfunctionNov 13, 2025Electrical /Electronic Property Problem; Battery Problem; Electrical /Electronic Property Problem; Battery Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING 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. THE TRILOGY EVO DEVICE WAS BEING EVALUATED BY A THIRD-PARTY) SERVICE CENTER. DURING THE EVALUATION IT WAS NOTED THAT AN ERROR CODE, BATTERY NOT CHARGING FAULT (E-059), WAS FOUND ON THE DEVICE'S ERROR LOG. THE THIRD-PARTY SERVICE TECHNICIAN FURTHER EVALUATED AND ALLEGED THE DETACHABLE BATTERY HAD CAUSED THE ERROR CODE TO OCCUR ON THE DEVICE SINCE THE DETACHABLE BATTERY WAS NOT RETURNED WITH THE DEVICE. IN CONCLUSION, THE DEVICE'S DETACHABLE BATTERY REPLACED TO ADDRESS THE ISSUE. A FINAL REPORT IS BEING SUBMITTED. 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. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, THE SOFTWARE WAS REINSTALLED DUE TO ANOTHER ERROR CODE, SOFTWARE UPGRADE FAULT (E-0317), WAS FOUND ON THE DEVICE'S ERROR LOG. THIS WAS UNRELATED TO THE REPORTED ISSUE. THE DETACHABLE BATTERY NEEDS REPLACING TO ADDRESS ANOTHER DEVICE ERROR CODE, DE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23544324 ↗
• MalfunctionNov 5, 2025Battery Problem; Battery 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 THIRD-PARTY SERVICE CENTER, A "SERVICE REQUIRED" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG RELATED TO EVT_BATTERY_NOT_CHARGING_FAULT. THE DEVICE'S DETACHABLE BATTERY HAS TO BE REPLACED TO ADDRESS THE ISSUE. INTERNAL BATTERY, MUFFLER, AIR FOAM INLET FILTER HAVE TO BE REPLACED DUE TO THE PREVENTIVE MAINTENANCE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23473976 ↗
• MalfunctionOct 29, 2025Electrical /Electronic Property Problem; Battery Problem; Electrical /Electronic Property Problem; Battery Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING "PREVENTIVE MAINTENANCE TO BE CARRIED OUT" FOR A TRILOGY EVO, FRANCE DEVICE. THERE WAS NO ALLEGATION OF PATIENT HARM. DURING EVALUATION OF THE TRILOGY EVO, FRANCE DEVICE AT A THIRD-PARTY SERVICE CENTER, AN ERROR EVT_INTERNAL_BATT_FAILED WAS DISCOVERED IN THE EVENT LOG. THE TECHNICIAN RECOMMENDED REPLACING THE DEVICE'S INTERNAL BATTERY TO ADDRESS THE ISSUE. NO REPAIR WAS PERFORMED; THE UNIT WAS NOT SERVICED DUE TO CUSTOMER'S REQUEST. ADDITIONALLY, THE DETACHABLE BATTERY NEEDS TO BE REPLACED TO ADDRESS AN EVT_DETACH_BATT_FAILED ERROR. THE SYSTEM BOARD NEEDS TO BE REPLACED TO ADDRESS EVT_HARD_POWER_FAIL AND EVT_START_STOP_LATCH_RESET_STUCK CODES FOUND IN THE EVENT LOG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23416128 ↗
• MalfunctionOct 16, 2025Display Difficult to Read; Display Difficult to Read

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE SCREEN WAS DAMAGED AND UNREADABLE THAT OCCURRED ON A TRILOGY EVO DEVICE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. THE TRILOGY EVO WAS EVALUATED AT THE THIRD-PARTY SERVICE CENTER. DURING THE EVALUATION IT WAS NOTED THAT THERE WAS DAMAGED TO THE SCREEN AND IT NEEDS TO BE REPLACED. IN CONCLUSION, THE DEVICE'S DISPLAY SCREEN NEEDS REPLACED TO ADDRESS THE ISSUE. THERE WERE NO REPAIR AND/OR PART(S) REPLACED ON THE DEVICE SINCE THE CUSTOMER REQUESTED THE DEVICE BE SCRAPPED. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, THE PARTICULATE FILTER AND AIR INLET FOAM FILTER NEEDS REPLACED FOR PREVENTATIVE MAINTENANCE UNRELATED TO THE REPORTABLE MALFUNCTION/ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23309468 ↗