Trilogy Evo EE2110X15BRecalls & reported problems

Summary

The FDA's MAUDE database contains 85 adverse event reports that list this exact device (DI 00606959055544), received between May 20, 2021 and Jun 24, 2026 — classified as 1 death, 84 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (37 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. 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 ↗

5. May 1, 2023Open, Classified

   Environmental debris may accumulate on the internal machine flow sensor causing partial occlusion which may impact accurate delivery of pressure, volume, or flow. A malfunction caused by this issue can result in patient harm up to hypoxemia if not addressed by the care provider.

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

Most reported problems

Recent adverse event reports

The 25 most recent of 85 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 24, 2026Electrical /Electronic Property Problem; Device Sensing Problem

  A TRILOGY EVO EASTERN EUROPE VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SCHEDULED 4-YEAR PREVENTIVE MAINTENANCE. THERE WAS NO REPORT OF PATIENT HARM OR INJURY ASSOCIATED WITH THIS EVENT. THE DEVICE WAS NOT REPORTED TO BE IN PATIENT USE AT THE TIME THE ISSUE WAS IDENTIFIED. DURING EVALUATION AT THE THIRD-PARTY SERVICE CENTER, AN ERROR INDICATING THAT THE AMOUNT OF FLUCTUATION DETECTED BY THE MACHINE FLOW SENSOR DEVIATED FROM THE ESTABLISHED STANDARD. EVALUATION DETERMINED THAT REPLACEMENT OF THE MACHINE FLOW SENSOR WAS REQUIRED TO CORRECT THE ISSUE. AS PART OF THE PREVENTIVE MAINTENANCE ASSESSMENT, REPLACEMENT OF THE DETACHABLE BATTERY WAS ALSO RECOMMENDED. ADDITIONALLY, THE AIR INLET FOAM FILTER, MUFFLER ASSEMBLY, AND PARTICULATE FILTER REQUIRED REPLACEMENT IN ACCORDANCE WITH THE SCHEDULED 4-YEAR PREVENTIVE MAINTENANCE PROCEDURE. A PREVENTIVE MAINTENANCE LABEL WAS APPLIED TO THE DEVICE. FURTHER EVALUATION IDENTIFIED EVT_MCL_FOC_SHUTDOWN, INDICATING THAT THE MOTOR CONTROLLER HAD ENTERED A SHUTDOWN STATE DUE TO A MOTOR-RELATED ERROR. AS A RESULT, THE BLOWER ASSEMBLY REQUIRED REPLACEMENT. THE DEVICE SOFTWARE WAS UPDATED TO VERSION 1.06.15.00. A FINAL REPORT IS BEING S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25614328 ↗
• MalfunctionJun 18, 2026Electrical /Electronic Property Problem; Battery Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR SERVICE REQUIRED FAULT HAD 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 THIRD-PARTY 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 THIRD-PARTY SERVICE TECHNICIAN FURTHER EVALUATED AND DETERMINED THE DETACHABLE BATTERY HAD CAUSED THE VENTILATOR SERVICE REQUIRED ALARM 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 AND PARTICULATE FILTER NEEDS REPLACED FOR PREVENTATIVE MAINTENANCE UNRELATED TO THE REPORTABLE MALFUNCTION/ISSUE. THE MACHINE FLOW SENSOR NEEDS REPLACED FOR AN ERROR CODE, MACHINE FLOW DRIFT LOG, THAT 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 25548162 ↗
• MalfunctionJun 18, 2026Circuit Failure; Electrical /Electronic Property Problem; Device Sensing Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A RED ALARM CONDITION INVOLVING A TRILOGY EVO VENTILATOR DURING PATIENT USE. NO PATIENT HARM OR INJURY WAS REPORTED. DURING THE IN PROCESS EVALUATION OF THE DEVICE AT A THIRD-PARTY SERVICE CENTER, REVIEW OF THE EVENT AND ERROR LOGS IDENTIFIED VENTILATOR INOPERATIVE EVENTS EVT_MOTOR_SHUTDOWN AND EVT_TPY_HELD_IN_BM. BASED ON THESE FINDINGS, REPLACEMENT OF THE SYSTEM PRINTED CIRCUIT ASSEMBLY (PCA) WAS RECOMMENDED. REVIEW OF THE ERROR LOG ALSO IDENTIFIED AN EVT_MACH_FLOW_DRIFT_HIGH VENTILATOR INOPERATIVE ERROR, INDICATING THAT THE MACHINE FLOW SENSOR HAD DRIFTED ABOVE SPECIFICATION AND REQUIRED REPLACEMENT. ADDITIONAL REVIEW OF THE ERROR LOG IDENTIFIED EVT_MCL_FOC_SHUTDOWN AND EVT_MOTOR_FLUX_MAGNITUDE_RUNTIME EVENTS, RESULTING IN A RECOMMENDATION TO REPLACE THE DEVICE BLOWER. THE AIR FOAM INLET FILTER AND PARTICULATE FILTER WERE IDENTIFIED FOR REPLACEMENT IN ACCORDANCE WITH PREVENTIVE MAINTENANCE REQUIREMENTS. ONE IN-LINE FILTER PROX WAS FOUND CONTAMINATED WITH DUST AND REQUIRED REPLACEMENT. AT THE TIME OF THIS REPORT, THE DEVICE WAS OUT OF WARRANTY AND AWAITING CUSTOMER APPROVAL FOR REPAIR. THE INVESTIGATION REMAINS ONGOING. NO PATIENT HA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25546365 ↗
• MalfunctionJun 17, 2026Circuit Failure; Operating System Version or Upgrade Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A MALFUNCTION OCCURRED DURING SOFTWARE UPDATE ON A TRILOGY EVO DEVICE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. THE TRILOGY EVO WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR EVALUATION FOR THIS ISSUE. DURING THE EVALUATION IT WAS NOTED THAT TWO ERROR CODES, EVENT SYSTEM VERSION MISMATCH POWER AND EVENT SYSTEM VERSION MISMATCH USER INTERFACE, WERE OBSERVED ON THE DEVICE'S ERROR LOG. THE THIRD-PARTY SERVICE TECHNICIAN FURTHER EVALUATED AND DETERMINED THAT THE DISPLAY PRINTED CIRCUIT ASSEMBLY (PCA) HAD GENERATED THESE TWO ERROR CODES ON THE DEVICE. IN CONCLUSION, THE DISPLAY PCA NEEDS REPLACED TO ADDRESS THE ISSUE. THE ROOT CAUSE WAS CONFIRMED ON THIS DEVICE. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, THE INTERNAL BATTERY NEEDS REPLACED DUE TO AN ERROR CODE, INTERNAL BATTERY DEPLETED, THAT WAS OBSERVED ON THE DEVICE'S ERROR LOG. THIS WAS UNRELATED TO THE REPORTABLE ISSUE. THE BLOWER NEEDS REPLACED FOR ANOTHER ERROR CODE, MOTOR CONTROLLER FORCE SHUTDOWN, WAS OBSERVED ON THE DEVICE'S ERROR LOG. THIS WAS UNRELATED TO THE REPORTABLE ISSUE. THE AIR INLET FOAM FILTER, MUFFLER ASSEMBLY, AND PARTICULATE FILT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25535541 ↗
• MalfunctionJun 4, 2026Circuit Failure; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION THAT A TRILOGY EVO VENTILATOR WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR EVALUATION OF THE ALLEGATION OF A MALFUNCTION OF THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT, AND NO HARM OR INJURY REPORTED. ON DEVICE EVALUATION, A VENTILATOR INOPERATIVE ERROR CODE WAS NOTED IN THE DEVICE ERROR LOG THAT INDICATES DATA IN THE ELECTRONICALLY ERASABLE PROGRAMABLE READ-ONLY MEMORY (EEPROM) IS CORRUPT ON SYSTEM/CENTRAL PROCESSING UNIT (CPU). THE DEVICE IS PENDING COMPLETED EVALUATION AND REPAIR. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25391474 ↗
• MalfunctionMay 11, 2026Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION FROM A DISTRIBUTOR ALLEGING A PATIENT EXPERIENCED SERVICE REQUIRED WHILE USING A TRILOGY EVO DEVICE. 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 25140948 ↗
• MalfunctionMay 5, 2026Electrical /Electronic Property Problem; Battery Problem; Power Problem

  THE TRILOGY EVO VENTILATOR WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER DUE TO THE ALLEGATION OF (AFTER THE SERVICE THE DEVICE STILL SAYS VENTILATOR SERVICE REQUIRED). THE DEVICE WAS NOT IN USE BY A PATIENT AT THE TIME OF THE OCCURRENCE. DURING THE INPROCESS EVALUATION OF THE DEVICE BY THE THIRD-PARTY SERVICE CENTER AN ERROR CODE IN RELATION TO INTERNAL BATTERY NOT DETECTED AND POWER VBUS DROPPED WERE RECORDED IN THE DEVICE EVENT LOG. THE SERVICE TECHNICIAN CONFIRMED THAT THE REPORTED ERROR CODS WERE DUE TO CONTAMINATION AND THAT NO CORRECTIVE ACTION WAS REQUIRED. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE AN ERROR CODE IN RELATION TO THE INTERNAL OR DETACHABLE LI-ION BATTERY IS NOT CHARGING DUE TO A HARDWARE FAULT GREATER THEN 1 MINUTE WAS OBSERVED IN THE DEVICE EVENT LOG, THEREFORE, THE DETACHABLE BATTERY NEEDS TO BE REPLACED TO ADDRESS THE ISSUE. ALSO ERROR CODES IN RELATION TO SOFT POWER FAIL, HARD POWER FAIL WERE RECORDED IN THE DEVICE EVENT LOG. THE BLOWER ASSY, BLOWER BELLOWS SEAL, MACHINE FLOW SENSOR, TUBING-BLOWER CHASSIS, TUBING-FIO2, TUBING-LOW FLOW O2 AND TUBING-SYSTEM BOARD ARE CONTAMINATED WITH DUST AND DIRT. PREVENTATIVE MAINTENANCE WILL BE PERFORMED, AND THE A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25079212 ↗
• MalfunctionApr 30, 2026Circuit Failure; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE 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, MACHINE FLOW DRIFT HIGH, WAS OBSERVED ON THE DEVICE'S ERROR LOG. THE THIRD-PARTY SERVICE TECHNICIAN FURTHER EVALUATED AND DETERMINED THE SYSTEM PRINTED CIRCUIT ASSEMBLY (PCA) HAD CAUSED THE VENTILATOR INOPERATIVE ERROR CODE TO OCCUR ON THE DEVICE. IN CONCLUSION, THE DEVICE'S SYSTEM PCA 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 SYSTEM PCA NEEDS REPLACED TO ADDRESS TWO ADDITIONAL ERROR CODES, MOTOR CONTROLLER FORCE SHUTDOWN AND DRIFT DEBUG, THAT WERE OBSERVED ON THE DEVICE'S ERROR LOG. THIS WAS UNRELATED TO THE REPORTABLE ISSUE. THE BUZZER NEEDS REPLACED FOR ANOTHER ERROR CODE, THERAPY BUZZER FAIL, THAT WAS OBSERVED O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25046073 ↗
• MalfunctionApr 30, 2026Electrical /Electronic Property Problem; Battery Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR SERVICE REQUIRED 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 THIRD-PARTY 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 IN THE DEVICE'S ERROR LOG. THE THIRD-PARTY SERVICE TECHNICIAN FURTHER EVALUATED AND DETERMINED THE DETACHABLE BATTERY HAD CAUSED THE VENTILATOR SERVICE REQUIRED 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 SYSTEM PRINTED CIRCUIT ASSEMBLY (PCA) NEEDS REPLACING FOR ANOTHER ERROR CODE, PRESS PAIR ERROR, THAT WAS OBSERVED ON THE DEVICE'S ERROR LOG. THE AIR INLET FOAM FILTER AND PARTICULATE FI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25045682 ↗
• MalfunctionApr 3, 2026Battery Problem

  A TRILOGY EVO WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. THE DEVICE WAS NOT IN PATIENT USE. THE TRILOGY EVO WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER AND MULTIPLE ERROR CODES RELATED TO THE BATTERY WERE OBSERVED. EVT_INTERNAL_BATT_NOT_DETECTED MEANS THE INTERNAL BATTERY CANNOT BE DETECTED. EVT_INTERNAL_BATT_DEPLETED MEANS THE INTERNAL LI-ION BATTERY IS DEPLETED AND HAS NOT BEEN DISCONNECTED. EVT_SOFT_POWER_FAIL MEANS THE LAST BATTERY IS DEPLETED AND AC IS NOT CONNECTED. 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 1 MINUTE. EVT_DETACH_BATT_WAKE_VOLT_FAILED MEANS THE DETACHABLE LI-ION BATTERY IS CONNECTED AND V_WAKE_DET IS GREATER THAN 10.000V. THE INTERNAL AND DETACHABLE BATTERIES NEED TO BE REPLACED TO ADDRESS THE ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24778733 ↗
• MalfunctionMar 18, 2026Contamination; Pressure Problem

  A TRILOGY EVO WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. THE TRILOGY EVO WAS RETURNED AND EVALUATED BY THE THIRD-PARTY SERVICE CENTER. THE DEVICE EVALUATION FOUND AN ERROR CODE RELATED TO PRESSURE. EVT_PRESS_SENSOR_MISMATCH MEANS THE DEVICE SOFTWARE HAS DETECTED A LARGE PRESSURE DROP BETWEEN THE MONITOR AND OUTLET PRESSURE SENSORS (I.E. ACROSS THE MACHINE FLOW SENSOR). THE CAUSE OF THE ERROR CODE WAS DETERMINED TO BE DUST/DIRT CONTAMINATION OF THE BLOWER, MACHINE FLOW SENSOR AND PROXIMAL FILTERS. THE BLOWER, MACHINE FLOW SENSOR, AND PROXIMAL FILTERS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24627061 ↗
• MalfunctionMar 17, 2026Contamination; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A PATIENT EXPERIENCED A VENTILATOR SERVICE REQUIRED WHILE USING THE TRILOGY EVO DEVICE. THERE WAS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS SPECIFIED BY THE PATIENT. THE TRILOGY EVO WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR EVALUATION, AND THE CUSTOMER¿S COMPLAINT WAS CONFIRMED. DURING THE EVALUATION IT WAS NOTED THAT AN ERROR CODE, PRESSURE SENSOR MISMATCH, WAS OBSERVED IN THE DEVICE'S ERROR LOG. THE THIRD-PARTY SERVICE TECHNICIAN FURTHER EVALUATED AND FOUND CONTAMINATION ON THE MACHINE FLOW SENSOR, IN-LINE FILTER PROXIMAL AND LOW-FLOW O2 TUBING THAT HAD CAUSED THE REPORTABLE ISSUE TO OCCUR ON THE DEVICE. IN CONCLUSION, THE DEVICE'S MACHINE FLOW SENSOR, IN-LINE FILTER PROXIMAL AND LOW-FLOW O2 TUBING WERE REPLACED TO ADDRESS THE ISSUE. THE ROOT CAUSE IS CONFIRMED AT THIS TIME. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, THE BLOWER ASSEMBLY WAS REPLACED FOR ANOTHER ERROR CODE, INLET FILTER BLOCK, THAT WAS OBSERVED ON THE DEVICE'S ERROR LOG. THIS WAS UNRELATED TO THE REPORTABLE ISSUE. THE SYSTEM PRINTED CIRCUIT ASSEMBLY WAS REPLACED FOR ANOTHER ERROR CODE, MOTOR FLUX MAGNITUDE RUNTIME,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24617456 ↗
• MalfunctionMar 12, 2026Failure to Calibrate; Pressure Problem

  THE MANUFACTURER RECEIVED INFORMATION FROM A CUSTOMER ALLEGING THAT THE TURBINE IS MAKING WHISTLING NOISE WHICH IS DISTURBING AT NIGHT. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. THE TRILOGY EVO WAS RETURNED AND EVALUATED BY A THIRD-PARTY SERVICE CENTER. THE DEVICE EVALUATION FOUND THAT MULTIPLE PARTS WERE CONTAMINATED WITH DUST AND DIRT. THERE WERE NO REPORTABLE ERROR CODES LISTED AS OCCURRING AS A RESULT OF THE DUST/DIRT CONTAMINATION AFTER THE ERROR LOG WAS REVIEWED, BUT MULTIPLE PARTS, INCLUDING THE MACHINE FLOW SENSOR, WERE REPLACED. AFTER THESE PARTS WERE REPLACED, THE DEVICE FAILED THE SYSTEM LEAK VERIFICATION: PRESSURE DROP OVER 10S TEST STEP DURING TESTING. THE DEVICE WAS NOT IN PATIENT USE DURING TESTING, WHEN THE ISSUE WAS OBSERVED. THE DEVICE'S MACHINE FLOW SENSOR WAS RESET TO ADDRESS THE ISSUE. THE DEVICE WAS RE-TEST AND PASSED. ADDITIONALLY, UNRELATED TO THE TEST FAIL, THE BLOWER ASSEMBLY WAS REPLACED DUE TO DUST AND DIRT CONTAMINATION. THE REPLACEMENT OF THE BLOWER ASSEMBLY SHOULD ADDRESS THE ISSUE OF THE TURBINE MAKING A WHISTLING NOISE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24586343 ↗
• MalfunctionFeb 27, 2026Electrical /Electronic Property Problem; Battery Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THAT AFTER THIRTY MINUTES OF TESTING A TRILOGY EVO DEVICE, THE DEVICE SHOWED A VENTILATOR SERVICE IS REQUIRED ON IT. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. 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 24472977 ↗
• DeathFeb 16, 2026Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A PATIENT DEATH OCCURRED WHILE USING A TRILOGY EVO VENTILATOR. A CLINICAL ASSESSMENT DETERMINED: THE REPORTED EVENT MAKES NO ALLEGATION OF ANY SPECIFIC DEVICE MALFUNCTION, USE ERROR, FAILURE, LABELING, OR OTHER DEFICIENCY THAT IS RELEVANT TO THE HARM REPORTED. THE CUSTOMER REPORTED THAT THE PATIENT DIED FROM AN MRSA INFECTION AND WILL BE RETURNING THE DEVICE WITH ITS ACCESSORIES FOR EVALUATION. BASED ON AVAILABLE INFORMATION AT THIS TIME, THE ALLEGED HARM DEATH IS ASSESSED AS NOT RELATED TO THE DEVICE IN THIS CASE. THEREFORE, BASED ON INFORMATION AVAILABLE AT THIS TIME, THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH. 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 MAKE GOOD FAITH EFFORT ATTEMPTS FOR ADDITIONAL INFORMATION AND TO RETRIEVE THE DEVICE FOR INVESTIGATION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

  Patient problems: Bacterial Infection

  MAUDE report 24344642 ↗
• MalfunctionJan 30, 2026Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A TRILOGY EVO VENTILATOR EXPERIENCED A SERVICE REQUIRED ALARM AFTER 5 HOURS OF OPERATION AFTER PREVIOUSLY BEING REPAIRED AT A THIRD-PARTY SERVICE CENTER. THE DEVICE WAS RETURNED ONCE AGAIN TO THE THIRD-PARTY SERVICE CENTER FOR ADDITIONAL SERVICE. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. DURING THE EVALUATION AT THE THIRD-PARTY SERVICE CENTER, TWO VENTILATOR INOPERATIVE ERROR CODES WERE FOUND IN THE DEVICE'S ERROR LOG RELATING TO 'MACHINE FLOW DRIFT HIGH' AND 'THERAPY HELD IN BM VENT INOP'. THERE IS NO DOCUMENTATION STATED ON A ROOT CAUSE AND/OR A COMPONENT REPLACEMENT TO RESOLVE THE ISSUES. THE SERVICE TECHNICIAN NOTES THAT THE VENTILATOR SERVICE REQUIRED ALARM APPEARED DUE TO A DEFECTIVE DETACHABLE BATTERY. THE SERVICE TECHNICIAN RECOMMENDS REPLACING THE DETACHABLE BATTERY TO RESOLVE THE ERROR. THE DEVICE PASSED THE FUNCTIONAL TESTING WITH A KNOWN, GOOD BATTERY. NO SERVICE MESSAGES APPEARED AFTER TESTING. ADDITIONALLY, THE AIR FOAM INLET FILTER AND PARTICULATE FILTER WERE REPLACED FOR PREVENTATIVE MAINTENANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24222880 ↗
• MalfunctionNov 20, 2025Electrical /Electronic Property Problem; Battery Problem; Electrical /Electronic Property Problem; Battery Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR SERVICE REQUIRED ALARM IS OCCURRING 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 IT WAS NOTED THAT AN ERROR CODE, BATTERY NOT CHARGING FAULT, WAS OBSERVED IN THE DEVICE'S ERROR LOG. THE THIRD-PARTY SERVICE TECHNICIAN ALLEGED THE DETACHABLE BATTERY WAS THE CAUSE OF THE ISSUE OCCURRING ON THE DEVICE. THE THIRD-PARTY SERVICE TECHNICIAN WAS NOT ABLE TO TEST IT WITH THE DETACHABLE BATTERY BECAUSE IT WAS NOT SENT WITH THE DEVICE FOR EVALUATION. IN CONCLUSION, THE DEVICE'S DETACHABLE BATTERY NEEDS REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, THE 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 23609693 ↗
• MalfunctionNov 6, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A BROKEN FAN. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT THIRD-PARTY SERVICE CENTER, A VENTILATOR INOPERATIVE ERROR CODE RELATED TO THE MACHINE FLOW SENSOR WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. EVT_MACH_FLOW_DRIFT_HIGH MEANS THE MACHINE FLOW SENSOR DRIFTED ABOVE THE SPECIFICATION (>0.2LPM). THE FLOW SENSOR WAS REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, UN-RELATED TO THE REPORTABLE MALFUNCTION/ERROR CODE, AN ERROR CODE RELATED TO THE MOTOR CONTROLLER AND AN ERROR CODE RELATED TO SENSOR OFFSET WERE FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. EVT_MCL_FOC_SHUTDOWN MEANS THE MOTOR CONTROLLER HAS PROCEEDED TO THE SHUTDOWN STATE DUE TO AN ERROR WITH THE MOTOR. THE BLOWER WAS REPLACED TO ADDRESS THE ISSUE. EVT_DRIFT_DEBUG MEANS THE SENSOR OFFSET DURING DRIFT CALCULATION IS TOO HIGH. THE CIRCUIT BOARD WAS REPLACED TO ADDRESS THE ISSUE. ALSO, ONE OF THE IN-LINE FILTERS PROX. WAS REPLACED DUE TO CONTAMINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23487598 ↗
• MalfunctionOct 24, 2025Display or Visual Feedback Problem; Electrical /Electronic Property Problem; Display or Visual Feedback Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A RED DISPLAY, NON-FUNCTIONING VENTILATOR OCCURRED ON A TRILOGY EVO. THE DEVICE WAS NOT REPORTED TO BE IN PATIENT USE AT THE TIME OF THE ALLEGATION. 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 23383416 ↗
• MalfunctionOct 22, 2025Circuit Failure; Electrical /Electronic Property Problem; Device Sensing Problem; Circuit Failure; Electrical /Electronic Property Problem; Device Sensing Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING "FAN NOT WORKING" ON A TRILOGY EVO, EASTERN EUROPE DEVICE. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE TRILOGY EVO, EASTERN EUROPE DEVICE AT THE THIRD-PARTY SERVICE CENTER, A VENTILATOR INOPERATIVE EVT_MACH_FLOW_DRIFT_HIGH ERROR WAS DISCOVERED IN THE DEVICE'S EVENT LOG. THE DEVICE'S MACHINE FLOW SENSOR WAS REPLACED TO ADDRESS THE ISSUE. HOWEVER, WHEN THE TECHNICIAN STARTED THE UNIT, A RED SCREEN WITH THE MESSAGE "VENT INOP" APPEARED AND WOULD NOT CLEAR EVEN AFTER MULTIPLE ATTEMPTS TO UPGRADE THE SYSTEM BOARD. THE DEVICE'S SYSTEM BOARD WAS REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, THE DEVICE'S BLOWER HAS BEEN REPLACED TO ADDRESS AN EVT_MCL_FOC_SHUTDOWN ERROR DISCOVERED IN THE EVENT LOG. ONE OF THE IN-LINE FILTERS WAS REPLACED DUE TO CONTAMINATION. THE AIR FOAM INLET FILTER, PARTICULATE FILTER AND MUFFLER WERE REPLACED DUE TO THE 4-YEAR PM PROCEDURE. 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 23359476 ↗
• MalfunctionOct 15, 2025Circuit Failure; Failure to Run on Battery; Circuit Failure; Failure to Run on Battery

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A TRILOGY EVO VENTILATOR EXPERIENCED AN UNIDENTIFIED DEVICE FAULT. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. THE TRILOGY EVO VENTILATOR WAS RETURNED AND EVALUATED BY A THIRD-PARTY SERVICE CENTER. THE SERVICE TECHNICIAN STATES THAT A BATTERY NOT CHARGING FAULT ERROR CODE WAS FOUND IN THE DEVICE'S ERROR LOG. THE SYSTEM PRINTED CIRCUIT ASSEMBLY (PCA) BOARD WAS REPLACED TO RESOLVE THE ISSUE. THE AIR INLET FOAM FILTER AND PARTICULATE FILTER WERE REPLACED FOR MAINTENANCE. THE DEVICE PASSED ALL FINAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23305705 ↗
• MalfunctionAug 8, 2025Circuit Failure; Output Problem; Circuit Failure; Output Problem

  THE MANUFACTURER RECEIVED INFORMATION A TRILOGY EVO "DEVICE FAILED. UNKNOWN FAULT. RED DISPLAY". THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS NOT IN PATIENT USE. THE DEVICE HAS BEEN RETURNED TO A THIRD-PARTY SERVICE CENTER, BUT EVALUATION HAS NOT YET BEGUN. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE SERVICE CENTER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22754671 ↗
• MalfunctionJul 23, 2025Failure to Charge; Failure to Charge

  A TRILOGY EVO VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. A VENTILATOR SERVICE REQUIRED ALARM WAS FOUND IN THE DEVICE ERROR LOG INDICATING THE INTERNAL OR DETACHABLE LI-ION BATTERY WAS NOT CHARGING DUE TO A HARDWARE FAULT FOR GREATER THAN, OR EQUAL TO 1 MINUTE. THE UNIT WAS TESTED WITH A GOLD DETACHABLE BATTERY BECAUSE THE UNIT CAME WITHOUT ONE. THE DEVICE WAS LEFT RUNNING FOR 4 HOURS AND NO ALARM APPEARED. IT IS POSSIBLE THAT THE DETACHABLE BATTERY USED BY THE CUSTOMER IS FAULTY AND NEEDS TO BE REPLACED. THIS ISSUE IS REPORTABLE BECAUSE THE SYSTEM CANNOT CHARGE THE INTERNAL BATTERY UNDER THIS CONDITION. 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 THE THIRD-PARTY SERVICER. THE DEVICE HISTORY RECORD HAS BEEN REVIEWED AND APPROVED BY THE THIRD-PARTY SERVICER'S QUALITY ASSURANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22579178 ↗
• MalfunctionJul 22, 2025Failure to Calibrate; Failure to Calibrate

  A TRILOGY EVO VENTILATOR WAS RETURNED TO THE THIRD-PARTY FOR SERVICE. THERE WAS NO PATIENT INVOLVEMENT, AND NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE DEVICE FAILED A TEST STEP DURING TESTING. THE DEVICE'S 3-WAY SOLENOID VALVE AND THE PROPORTIONAL VALVE WERE REPLACED TO ADDRESS THE ISSUE. ADDITIONAL FINDINGS NOT RELATED TO THE MALFUNCTION/ISSUE: THE INTERNAL LITHIUM-ION BATTERY WAS REPLACED AS PART OF REGULAR SERVICE AND VISUAL CONTAMINATION WAS NOTED INSIDE THE DEVICE DURING INSPECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22564282 ↗
• MalfunctionJul 11, 2025Circuit Failure; Electrical /Electronic Property Problem; Circuit Failure; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A BROKEN FAN FOR A TRILOGY EVO DEVICE. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, A VENTILATOR INOPERATIVE ERROR WAS DISCOVERED IN THE DEVICE'S EVENT LOG. THE TECHNICIAN RECOMMENDED REPLACING THE DEVICE'S CIRCUIT BOARD TO ADDRESS THE ISSUE. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. ADDITIONALLY, THE DEVICE'S IN-LINE FILTER IS CONTAMINATED, AIR INLET FOAM FILTER REPLACE DUE TO PREVENTIVE MAINTENANCE AND WERE REPLACED. THE 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 22478704 ↗