Trilogy Trilogy Evo Ventilator, IberiaRecalls & reported problems

Summary

The FDA's MAUDE database contains 94 adverse event reports that list this exact device (DI 00606959054080), received between Dec 21, 2020 and Jun 8, 2026 — classified as 94 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (37 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 94 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 8, 2026Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A BROKEN SCREEN IN A TRILOGY EVO IBERIA DEVICE. NO HARM OR INJURY WAS REPORTED. THE DEVICE WAS NOT IN PATIENT USE AT THE TIME OF THE EVENT. THE DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER; HOWEVER, THE EVALUATION HAS NOT YET BEGUN. A REVIEW OF THE DEVICE LOG IDENTIFIED AN EVT_INTERNAL_BATT_FAILED ERROR, WHICH INITIATED THIS REPORT. THE MANUFACTURER'S INVESTIGATION IS ONGOING. AT THIS TIME, THE ROOT CAUSE HAS NOT BEEN DETERMINED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25430546 ↗
• MalfunctionJun 8, 2026Electrical /Electronic Property Problem; Mechanical Problem; Device Contamination with Chemical or Other Material

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A BLOWER CALIBRATION FAILURE IN A TRILOGY EVO IBERIA DEVICE. NO HARM OR INJURY WAS REPORTED. THE DEVICE WAS NOT IN PATIENT USE AT THE TIME OF THE EVENT. THE DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER; HOWEVER, THE EVALUATION HAS NOT YET BEGUN. A REVIEW OF THE DEVICE LOG IDENTIFIED AN EVT_MACH_FLOW_DRIFT_HIGH ERROR, WHICH INITIATED THIS REPORT. THE MANUFACTURER'S INVESTIGATION IS ONGOING. AT THIS TIME, THE ROOT CAUSE HAS NOT BEEN DETERMINED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25430331 ↗
• MalfunctionJun 1, 2026Circuit Failure; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A TRILOGY EVO, IBERIA DEVICE HAD A "VENTILATOR INOPERATIVE" CONDITION OCCUR. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. THE DEVICE WAS NOT DOCUMENTED TO BE IN PATIENT USE. THE EVALUATION OF THE DEVICE HAS NOT YET BEGUN. THE DEVICE WAS RETURNED 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 25348994 ↗
• MalfunctionMay 29, 2026Display or Visual Feedback Problem

  A TRILOGY EVO WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER WITH AN ALLEGATION OF A DISPLAY MALFUNCTION. NO MEDICAL INTERVENTION WAS SPECIFIED. THE DEVICE WAS NOT REPORTED TO BE IN CLINICAL USE. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DISPLAY BOARD DEFECTIVE ERROR CODE WAS CONFIRMED. THE TRILOGY EVO DEVICE'S DISPLAY CIRCUIT BOARD NEEDS TO BE REPLACED TO ADDRESS THE REPORTED OCCURRENCE. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25339931 ↗
• MalfunctionMay 4, 2026Power Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A TRILOGY EVO VENTILATOR EXPERIENCED LOW PRESSURE. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. DURING EVALUATION OF THE DEVICE AT THE THIRD PARTY SERVICE CENTER, THREE REPORTABLE EVENTS WERE FOUND IN THE DEVICE'S ERROR LOG RELATING TO 'SOFT POWER FAIL', 'HARD POWER FAIL' AND 'POWER VBUS DROPPED.' THERE IS NO DOCUMENTATION STATED ON A ROOT CAUSE AND/OR A COMPONENT REPLACEMENT TO RESOLVE THESE EVENTS. ADDITIONALLY, THERE IS NO DOCUMENTATION STATED ON A ROOT CAUSE AND/OR A COMPONENT REPLACEMENT FOR THE LOW PRESSURE ALLEGATION. IT IS NOTED THAT THE BLOWER, MACHINE FLOW SENSOR, AND PROXIMAL FILTERS WERE REPLACED DUE TO DUST CONTAMINATION. THE AIR FOAM INLET FILTER, PARTICULATE FILTER, AND MUFFLER WERE REPLACED FOR MAINTENANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25070129 ↗
• MalfunctionMay 1, 2026Device Sensing Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THAT A TRILOGY EVO DEVICE IS MISSING A SERVICE KIT. NO MEDICAL INTERVENTION WAS SPECIFIED. THE DEVICE WAS NOT REPORTED TO BE IN CLINICAL USE AT THE TIME OF THE ALLEGATION. THE TRILOGY EVO DEVICE WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR EVALUATION ALONG WITH THE ERROR LOG. AN ERROR RELATED TO A PRESSURE SENSOR MISMATCH WAS DISCOVERED WITHIN THE LOGS, AND DUE TO THE PREVENTATIVE MAINTENANCE ACTIVITIES, THE MACHINE FLOW SENSOR WAS ALSO OBSERVED TO BE CONTAMINATED WITH DUST AND NEEDS TO BE REPLACED TO ADDRESS THE ISSUE. THE UNIT WAS RETURNED UNREPAIRED AS PER THE CUSTOMER REQUEST. 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 25055723 ↗
• MalfunctionApr 28, 2026Circuit Failure; Battery Problem

  THE MANUFACTURER RECEIVED INFORMATION THAT A TRILOGY EVO VENTILATOR WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR EVALUATION. THERE WAS NO PATIENT INVOLVEMENT, AND NO HARM OR INJURY REPORTED. ON EVALUATION, REVIEW OF THE DEVICE ERROR LOG INDICATED RECORD OF ERROR CODE E-47 INDICATING THE INTERNAL LI-ION BATTERY IS REPORTING A PERMANENT FAILURE. REPLACEMENT OF THE INTERNAL LI-ION BATTERY IS REQUIRED TO ADDRESS THIS ISSUE. DEVICE ERROR CODE E-156 WAS ALSO NOTED IN THE DEVICE ERROR LOG INDICATING A VENTILATOR INOPERATIVE CONDITION OF THE THERAPY CENTRAL PROCESSING UNIT (CPU) STILL RUNNING IN BOOT MONITOR SOFTWARE. THE SYSTEM PRINTED CIRCUIT BOARD ASSEMBLY (PCA) REPLACEMENT IS REQUIRED TO ADDRESS THIS ISSUE. ADDITIONAL FINDINGS NOT RELATED TO THE MALFUNCTION/ISSUE: THE MAIN HOUSING, INTERNAL BATTERY DOOR, FRONT PANEL BUTTON AND WARNING LABEL WERE DAMAGED. THE BLOWER ASSEMBLY, MACHINE FLOW SENSOR, TUBING SYSTEM PCA, TUBING FIO2, TUBING BLOWER CHASSIS AND TUBING LOW FLOW OXYGEN WERE CONTAMINATED WITH DIRT AND DUST. THE FILTER COVER WAS MISSING. FOUR-YEAR PREVENTATIVE MAINTENANCE WAS COMPLETED ON THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25015511 ↗
• MalfunctionApr 27, 2026Circuit Failure; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED A REPORT THAT A TRILOGY EVO VENTILATOR WAS UNABLE TO ACCEPT SOFTWARE UPDATES. NO PATIENT HARM OR INJURY WAS REPORTED. DURING IN-PROCESS EVALUATION AT A THIRD-PARTY SERVICE CENTER, THE DEVICE SOFTWARE WAS SUCCESSFULLY UPGRADED TO VERSION 1.06.15.00. DEVICE LOG FILES WERE DOWNLOADED AND FULLY REVIEWED. ANALYSIS IDENTIFIED A ¿VENT INOP¿ ALARM ASSOCIATED WITH THE THERAPY CPU REMAINING IN BOOT MONITOR MODE. TO CORRECT THIS CONDITION, REPLACEMENT OF THE SYSTEM PRINTED CIRCUIT ASSEMBLY (PCA) IS REQUIRED. ADDITIONALLY, THE IN-LINE FILTER WAS FOUND TO BE CONTAMINATED. AS PART OF THE FOUR-YEAR PREVENTIVE MAINTENANCE, THE MUFFLER ASSEMBLY, AIR INLET FOAM FILTER, PARTICULATE FILTER, AND MAINTENANCE LABEL REQUIRE REPLACEMENT. 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, A FOLLOW UP/SUPPLEMENTAL REPORT WILL BE COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24998252 ↗
• MalfunctionApr 16, 2026Electrical /Electronic Property Problem; Battery Problem

  A TRILOGY EVO, IBERIA VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE, AT WHICH TIME IT WAS REPORTED THAT THE SERVICE KIT WAS MISSING. THE ISSUE WITH THE SERVICE KIT WAS RESOLVED. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. THE DEVICE WAS NOT REPORTED TO BE IN PATIENT USE. DURING THE EVALUATION OF THE TRILOGY EVO, IBERIA DEVICE AT A THIRD-PARTY SERVICE CENTER, AN EVT_BATTERY_NOT_CHARGING_FAULT ERROR WAS IDENTIFIED IN THE DEVICE'S EVENT LOG. THIS ERROR INDICATES THAT THE INTERNAL OR DETACHABLE LI-ION BATTERY WAS NOT CHARGING DUE TO A HARDWARE FAULT FOR A DURATION OF GREATER THAN OR EQUAL TO ONE MINUTE. THE SERVICE TECHNICIAN RECOMMENDED REPLACEMENT OF THE DEVICE'S INTERNAL BATTERY TO ADDRESS THIS ISSUE. ADDITIONAL EVALUATION DETERMINED THAT THE DEVICE'S SYSTEM BOARD REQUIRES REPLACEMENT DUE TO THE PRESENCE OF EVT_SW_UPGRADE_FAILURE AND EVT_DRIFT_DEBUG ERROR CODES. OTHER NON-ACTIONABLE ERRORS FOUND IN THE EVENT LOG WERE ATTRIBUTED TO CONTAMINATION. THE DEVICE'S TUBING-FIO2, IN-LINE FILTER, AND MACHINE FLOW SENSOR WERE FOUND TO BE CONTAMINATED WITH DIRT AND WILL REQUIRE REPLACEMENT. AS PART OF THE 4-YEAR PREVENTIVE MAINTENANCE PROCEDURE, THE AIR FOAM INLET FILTE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24894709 ↗
• MalfunctionApr 16, 2026Electrical /Electronic Property Problem; Device Sensing Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING MAINTENANCE WAS REQUIRED ON A TRILOGY EVO VENTILATOR. THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. THE TRILOGY EVO WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR EVALUATION. 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 CAUSED BY CONTAMINATION IN THE MACHINE FLOW SENSOR. PHILIPS IS CURRENTLY INVESTIGATING THIS COMPLAINT. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24894154 ↗
• MalfunctionApr 15, 2026Electrical /Electronic Property Problem; Device Sensing Problem

  THE MANUFACTURER RECEIVED A REPORT THAT A TRILOGY EVO VENTILATOR WAS RETURNED FOR SERVICE. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY ASSOCIATED WITH THIS EVENT. THE DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION. THE DEVICE LOG FILES WERE SUCCESSFULLY DOWNLOADED AND REVIEWED. DURING "IN PROCESS" EVALUATION, ANALYSIS IDENTIFIED A ¿VENT INOP¿ CONDITION ASSOCIATED WITH MACHINE FLOW SENSOR DRIFT EXCEEDING SPECIFICATION (>0.2LPM). REPLACEMENT OF THE MACHINE FLOW SENSOR WAS DETERMINED TO BE NECESSARY TO ADDRESS THIS CONDITION. ADDITIONALLY, MULTIPLE EVENT ERRORS WERE IDENTIFIED THAT WERE UNRELATED TO THE REPORTED MALFUNCTION. THESE EVENTS INDICATED THAT THE MOTOR CONTROLLER ENTERED A SHUTDOWN STATE DUE TO A MOTOR-RELATED ERROR, AND THE MOTOR FLUX MEASUREMENT IS EITHER TOO HIGH OR TOO LOW WHEN THE MOTOR IS IN THE RUN STATE. REPLACEMENT OF THE BLOWER ASSEMBLY WAS IDENTIFIED AS THE APPROPRIATE CORRECTIVE ACTION FOR THESE FINDINGS. AN ADDITIONAL EVENT INDICATED THAT A SENSOR OFFSET DURING DRIFT CALCULATION EXCEEDED ALLOWABLE LIMITS; REPLACEMENT OF THE SYSTEM PRINTED CIRCUIT ASSEMBLY (PCA) WAS DETERMINED TO BE REQUIRED. INSPECTION ALSO IDENTIFIED CONTAMINATION OF THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24886711 ↗
• MalfunctionApr 13, 2026Failure to Calibrate; Device Sensing Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE PILOT READING TEST STEP HAD FAILED ON A TRILOGY EVO DEVICE. THE DEVICE WAS NOT IN PATIENT USE. THE TRILOGY EVO DEVICE WAS EVALUATED BY A THIRD-PARTY SERVICE ENGINEER (SE). THE DEVICE EVALUATION FOUND PROPORTIONAL VALVE AND THREE-WAY (3-WAY) SOLENOID VALVE HAD CAUSED THE PILOT READING TEST STEP TO FAIL ON THE DEVICE. THE PHILIPS SE REPLACED THE DEVICE'S PROPORTIONAL VALVE AND 3-WAY SOLENOID VALVE TO ADDRESS THIS ISSUE. AFTER THE PHILIPS SE REPLACED THE PARTS ON THE DEVICE, THE DEVICE WAS PLACED BACK INTO SERVICE. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, THE FIO2 CABLE WAS REPLACED FOR CONTAMINATION, AND IT HAD TAPE ON IT. THIS WAS UNRELATED TO THE REPORTABLE ISSUE. THE SYSTEM PRINTED CIRCUIT ASSEMBLY (PCA) WAS REPLACED FOR ONE OF THE CONNECTORS WAS A "LITTLE BIT" DETACHED AND LOOSE ON THE SYSTEM PCA. THIS WAS UNRELATED TO THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24860407 ↗
• MalfunctionApr 1, 2026Electrical /Electronic Property Problem; Battery Problem

  A VENTILATOR 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 SERVICE REQUIRED ALARM CONDITION INDICATING AN INTERNAL BATTERY FAILURE WAS OBSERVED IN THE DEVICE'S DOWNLOADED EVENT LOG. THE DEVICE'S INTERNAL BATTERY WAS REPLACED TO ADDRESS THE ISSUE. THERE ARE COMPONENTS NEEDING TO BE REPLACED DUE TO PREVENTIVE MAINTENANCE AND CONTAMINATION. THE FINAL EVALUATION HAS NOT YET BEEN COMPLETED. 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 24752160 ↗
• MalfunctionMar 30, 2026Battery Problem; Power 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 SERVICE REQUIRED ALARM INDICATING A POWER SOURCE ISSUE AND AN INTERNAL BATTERY NOT DETECTED WERE OBSERVED IN THE DEVICE'S DOWNLOADED EVENT LOG. THERE WAS NO DOCUMENTATION OF ANY COMPONENTS REPLACED TO ADDRESS THESE ISSUES. ADDITIONALLY, NOT RELATED TO THE REPORTABLE ISSUES, A SERVICE REQUIRED ALARM INDICATING THE DETACHABLE BATTERY FAILED WAS OBSERVED. THE DETACHABLE BATTERY WAS REPLACED TO ADDRESS THE ISSUE. THIS WOULD NOT AFFECT THE DEVICE'S ABILITY TO DELIVER THERAPY AS DESIGNED. ALTHOUGH NO COMPONENTS WERE REPLACED FOR THE REPORTABLE ISSUES, THE DEVICE WAS TESTED AND PASSED ALL FINAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24716106 ↗
• MalfunctionMar 24, 2026No Tactile Prompts/Feedback

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A TOUCHSCREEN FAILURE OCCURRED ON A TRILOGY EVO. 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. DURING THE EVALUATION, IT WAS NOTED THAT TOUCHSCREEN WAS NOT WORKING BECAUSE A FLEX CABLE WAS DISCONNECTED. IN CONCLUSION, THE DEVICE'S CABLE WAS RECONNECTED 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 24673032 ↗
• MalfunctionMar 20, 2026Electrical /Electronic Property Problem; Battery Problem; Device Sensing Problem; Unexpected Shutdown

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A RAR READING ERROR VTI AND VTE OCCURRED REGARDING A TRILOGY EVO VENTILATOR. THE DEVICE WAS NOT USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. THE TRILOGY EVO VENTILATOR WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR EVALUATION. WHILE REVIEWING THE ERROR LOG, CRITICAL ERROR CODES IN RELATION TO (SOFT POWER FAILURE, THE DEVICE SOFTWARE HAS DETECTED A LARGE PRESSURE DROP BETWEEN THE MONITOR AND OUTLET PRESSURE SENSORS, INTERNAL BATTERY DEPLETED AND INTERNAL BATTERY NOT DETECTED) WAS OBSERVED. THE MANUFACTURER INVESTIGATION IS ONGOING. IF NEW INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL REPORT WILL BE COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24647678 ↗
• MalfunctionMar 18, 2026Electrical /Electronic Property Problem; Battery Problem

  A TRILOGY EVO IBERIA VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR FOUR-YEAR PREVENTATIVE MAINTENANCE. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. THERE WAS NO ALLEGATION OF HARM OR INJURY REPORTED. THE DEVICE WAS NOT REPORTED TO BE IN PATIENT USE. DURING THE "IN PROCESS" EVALUATION OF THE TRILOGY EVO IBERIA DEVICE AT THIRD-PARTY SERVICE CENTER, AN EVT_BATTERY_NOT_CHARGING_FAULT ERROR CODE WAS DISCOVERED IN THE DEVICE'S EVENT LOG. THE ROOT CAUSE IS A DEFECTIVE BATTERY AND THE DEVICE'S INTERNAL BATTERY NEEDS TO BE REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, NOT RELATED THE DEVICE'S SYSTEM BOARD TUBING IS CONTAMINATED; AND IT NEEDS TO BE REPLACED. PER THE REQUIREMENT OF THE FOUR-YEAR PREVENTATIVE MAINTENANCE THE DEVICE'S AIR FOAM INLET FILTER, PARTICULATE FILTER AND MUFFLER WILL BE REPLACED. 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 24626168 ↗
• MalfunctionMar 16, 2026Circuit Failure; Display or Visual Feedback Problem; Battery Problem; Power Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A TRILOGY EVO VENTILATOR TOUCHSCREEN IS NOT WORKING. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. THE DEVICE HAS BEEN RETURNED TO A THIRD PARTY SERVICE CENTER AND IS AWAITING TO BE FURTHER EVALUATED. THE DEVICE'S ERROR LOG WAS MADE AVAILABLE AND CONFIRMED THAT A 'SOFT POWER FAIL', 'HARD POWER FAIL', AND 'TOUCHSCREEN FAILURE' ERROR CODES WERE PRESENT. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24613668 ↗
• MalfunctionMar 3, 2026Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION FROM A CUSTOMER THAT A COOLING FAN NOISE OCCURRED ON A TRILOGY EVO VENTILATOR WHILE IN USE ON A PATIENT. THE TRILOGY EVO VENTILATOR WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR EVALUATION; AND THE CUSTOMER¿S COMPLAINT WAS CONFIRMED. DURING THE EVALUATION IT WAS NOTED THAT THE DEVICES COOLING FAN AND INLET SIDE ARE BOTH DAMAGED AND WERE REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, DURING THE EVALUATION CRITICAL ERROR CODES IN RELATION TO (THERAPY CENTRAL PROCESSING UNIT (CPU) IS STILL RUNNING IN BOOT MONITOR SOFTWARE.) AND (SOFT POWER FAIL) WERE RECORDED IN THE DEVICE EVENT LOG. THE DEVICE PASSED ALL FUNCTIONAL TESTING, AND NO FUNCTIONAL DEFECTS WERE FOUND. THE AIR FOAM INLET FILTER AND PARTICULATE FILTER WERE REPLACED FOR PREVENTATIVE MAINTENANCE UNRELATED TO THE REPORTABLE MALFUNCTION/ISSUE. THE DEVICE PASSED ALL FINAL TESTING. THE 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 24494500 ↗
• MalfunctionFeb 26, 2026Circuit Failure; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING ASSISTANCE REQUIRED. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. THE DEVICE WAS NOT IN PATIENT USE. DURING THE INITIAL EVALUATION OF THE DEVICE AT THIRD-PARTY SERVICE CENTER, VENTILATOR INOPERATIVE ERROR CODES WERE OBSERVED. EVT_TPY_HELD_IN_BM MEANS THE THERAPY CPU IS STILL RUNNING IN BOOT MONITOR SOFTWARE. THE SYSTEM BOARD NEEDS TO BE REPLACED TO ADDRESS THE ISSUE. EVT_SYSTEM_VERSION_MISMATCH_UI MEANS THE UI SOFTWARE VERSION STRING DOES NOT MATCH THE OVERALL SYSTEM VERSION STRING. THE DISPLAY BOARD NEEDS TO BE REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, DURING THE INITIAL EVALUATION OF THE DEVICE AT THIRD-PARTY SERVICE CENTER, NON-VENTILATOR INOPERATIVE ERROR CODES WERE OBSERVED. EVT_KEYPAD_STUCK MEANS ONE OF THE PHYSICAL KEYS IS STUCK, OR THERE IS AN ISSUE WITH THE KEYPAD. THERE WAS NO REPORT THAT DEVICE COULD NOT BE POWERED ON SO THERAPY CAN BE CHANGED VIA TOUCHSCREEN. ALSO, EVT_AUDIO_PAUSE_KEY_STUCK MEANS THE AUDIO PAUSE BUTTON ON THE KEYPAD IS STUCK. THE FRONT PANEL / KEYPAD NEEDS TO BE REPLACED TO ADDRESS THESE ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24460542 ↗
• MalfunctionFeb 17, 2026Charging Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING MISSING SERVICE KIT. 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, AN ERROR CODE RELATED TO CHARGING OF THE BATTERY WAS OBSERVED 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 1 MINUTE. THE DEVICE EVALUATION DOES NOT IDENTIFY ANY SPECIFIC COMPONENT MALFUNCTION THAT WOULD NEED TO BE REPLACED TO RESOLVE THE REPORTED ERROR CODE AND THE DEVICE DID PASS THE FUNCTIONAL TEST DURING EVALUATION, INCLUDING THE POWER SOURCE VERIFICATION TEST STEPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24365889 ↗
• MalfunctionFeb 16, 2026Power Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING DEVICE TEST. 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, AN ERROR CODE RELATED TO POWER WAS OBSERVED IN THE ERROR LOG. EVT_POWER_VBUS_DROPPED COULD MEAN THAT THE V_BUS DROPPED BELOW 8.000V, ALL POWER SOURCES DEPLETED, A FAULT IN LAST POWER SOURCE, OR THERE WAS A POWER PATH CIRCUIT FAULT. THE DEVICE EVALUATION DOES NOT IDENTIFY ANY SPECIFIC COMPONENT MALFUNCTION THAT WOULD NEED TO BE REPLACED TO RESOLVE THE REPORTED ERROR AND THE DEVICE WAS ABLE TO PASS THE FUNCTIONAL TEST. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24347650 ↗
• MalfunctionFeb 16, 2026Contamination; Pressure Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING MISSING SERVICE KIT. 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, AN ERROR CODE RELATED TO PRESSURE WAS OBSERVED IN THE ERROR LOG. 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 DEVICE EVALUATION DOES NOT IDENTIFY ANY SPECIFIC COMPONENT MALFUNCTION THAT WOULD NEED TO BE REPLACED TO RESOLVE THE REPORTED ERROR CODE, BUT THE MACHINE FLOW SENSOR (PART# 1135249) WAS REPLACED DUE TO BEING CONTAMINATED WITH DUST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24345287 ↗
• MalfunctionFeb 13, 2026Mechanical Problem; Failure to Calibrate; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A TRILOGY EVO VENTILATOR FAILED AN ACTIVE EXHALATION VERIFICATION TEST. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24340143 ↗
• MalfunctionFeb 13, 2026Failure to Calibrate; No Apparent Adverse Event

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR FAILED AN ACTIVE EXHALATION VERIFICATION TEST STEP DURING TESTING. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS NOT IN PATIENT USE. THE DEVICE HAS NOT YET RETURNED FOR EVALUATION. THE MANUFACTURER IS UNABLE TO CONFIRM THE ISSUE AT THIS TIME. 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 24337661 ↗