Trilogy Evo Trilogy Evo, USARecalls & reported problems

Summary

The FDA's MAUDE database contains 4,393 adverse event reports that list this exact device (DI 00606959051942), received between Sep 9, 2020 and Sep 30, 2026 — classified as 50 deaths, 34 injuries, 4,309 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (1,768 reports).

6 FDA recall records name this device's identifier, 6 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 ↗

6. Dec 22, 2021Class IOpen, Classified

   Philips has identified a specific lot of non-conforming material manufactured by one of its suppliers. A Philips supplier incorrectly used polyester-based polyurethane (PE-PUR) sound abatement foam, a non-conforming material in the devices and repair kits. PE-PUR foam may degrade into particles which may enter the device s air pathway and be ingested or inhaled by the user. The foam degradation may be exacerbated by use of unapproved cleaning methods such as unapproved ozone cleaners, and the PE-PUR foam may off-gas certain chemicals during initial use of the device.

   Z-0493-2022 · Root cause: Mixed-up of materials/components · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 4,393 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952644 ↗
• MalfunctionSep 30, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952153 ↗
• MalfunctionSep 30, 2026Electrical /Electronic Property Problem; Battery Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951679 ↗
• MalfunctionSep 30, 2026Electrical /Electronic Property Problem

  The manufacturer received information alleging a power v_bus dropped error code had occurred 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, event power vbus dropped, was observed on the device's error log. 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. Another error code, event soft power fail, was observed on the device's error log. The third-party service technician provided no documentation stated on a root cause and/or any component replacement to resolve the event soft power fail error code. There was no repair information was provided, and no part(s) were replaced to address this issue. The root cause isn't 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951010 ↗
• MalfunctionSep 30, 2026Electrical /Electronic Property Problem

  The manufacturer received information alleging a power v_bus dropped error code had occurred 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, event power vbus dropped, was observed on the device's error log. 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. Another error code, event soft power fail, was observed on the device's error log. The third-party service technician provided no documentation stated on a root cause and/or any component replacement to resolve the event soft power fail error code. There was no repair information was provided, and no part(s) were replaced to address this issue due to the customer request to scrap the device. The root cause isn't 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 th

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949243 ↗
• MalfunctionSep 30, 2026Battery Problem

  The manufacturer received information that a Trilogy Evo ventilator was returned to a third-party service center for evaluation. There was no patient involvement, and no harm or injury reported.On device evaluation, the internal lithium-ion battery was found to be defective and requiring replacement.Additional findings not related to the malfunction/issue: The flow sensor was due for replacement per FCO0000003. There was no report of a flow sensor failure on evaluation. The detachable battery was found to be defective on evaluation, requiring replacement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947331 ↗
• MalfunctionSep 30, 2026Circuit Failure; Electrical /Electronic Property Problem

  A Trilogy EVO ventilator was returned to the manufacturer's service center for evaluation. There was no harm or injury reported. During the evaluation, a Ventilator Inoperative alarm was observed indicating data in EEPROM was corrupt on the System/CPU. The System Printed Circuit Assembly (PCA) needed to be replaced to correct the issue. A final report is being submitted. If new information becomes available 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 50945584 ↗
• MalfunctionSep 30, 2026Electrical /Electronic Property Problem; Failure to Recalibrate; Infusion or Flow Problem

  A Trilogy EVO ventilator was returned to a third-party service center for service due to FSN 2024-CC_SRC_013. During the evaluation the device failed testing for Flow Verification: Positive Flow: Measured Tidal Volume and Flow Verification: Negative Flow: Measured Tidal Volume. However, the device passed the pneumatic test. The device evaluation does not identify any specific component malfunction that would need to be replaced to resolve the failed test steps, but it does confirm that the device was corrected. The device was corrected, retested and passed the final test.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50943602 ↗
• MalfunctionSep 29, 2026Failure to Calibrate

  A Trilogy EVO was returned to a third-party service center for evaluation. There was no harm or injury reported. There was no evidence the device was in patient use. During the evaluation the device failed the positive and negative flow verification test steps. There was no documentation of any components replaced for this issue. The device was retested and passed all final testing.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50937519 ↗
• MalfunctionSep 28, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50922505 ↗
• MalfunctionAug 27, 2026Electrical /Electronic Property Problem

  The manufacturer received a report that a Trilogy EVO ventilator was returned for service. There were no reports or allegations of patient harm or injury. The device was evaluated at a third-party service center. Review of the error logs identified a Vent Service Required alarm indicating the device software detected a large pressure drop between the monitor and outlet pressure sensors. An error was also observed indicating the VBUS dropped below 8.000V. There was no documentation specifying which component was replaced to address these errors.Following completion of the service activities, the device passed all functional and performance testing.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50475438 ↗
• MalfunctionAug 27, 2026Electrical /Electronic Property Problem

  The manufacturer received a report that a Trilogy EVO ventilator was returned for service. There were no reports or allegations of patient harm or injury. The device was evaluated at a third-party service center. Review of the error logs identified an error indicating the VBUS dropped below 8.000V. There was no documentation specifying which component was replaced to address the error. In addition, heavy dust, dirt, and odor was observed during the evaluation.Following completion of the service activities, the device passed all functional and performance testing.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50474241 ↗
• MalfunctionJun 30, 2026Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A TRILOGY EVO DISPLAYED A VENTILATOR INOPERABLE ALARM CONDITION. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25668852 ↗
• MalfunctionJun 29, 2026Electrical /Electronic Property Problem; Device Sensing Problem

  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 EVALUATED AND DETERMINED THE MACHINE FLOW SENSOR HAD CAUSED THE VENTILATOR SERVICE REQUIRED ERROR CODE TO OCCUR ON THE DEVICE. IN CONCLUSION, THE DEVICE'S MACHINE FLOW SENSOR WAS REPLACED TO ADDRESS THE ISSUE. THE ROOT CAUSE IS CONFIRMED AT THIS TIME. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, THE AIR INLET FOAM FILTER WAS REPLACED FOR UNKNOWN REASON BY THE THIRD-PARTY SERVICE TECHNICIAN. THIS WAS UNRELATED TO THE REPORTABLE ISSUE. THE DEVICE PASSED ALL FINAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25659122 ↗
• MalfunctionJun 29, 2026Circuit Failure; Electrical /Electronic Property Problem; Device Sensing 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 EVALUATED AND DETERMINED THE MACHINE FLOW SENSOR HAD CAUSED THE ERROR TO OCCUR ON THE DEVICE. ANOTHER ERROR CODE, POWER VBUS DROPPED, WAS OBSERVED ON THE DEVICE'S ERROR LOG. THE SYSTEM PRINTED CIRCUIT ASSEMBLY (PCA) HAD CAUSED THIS ERROR CODE TO OCCUR ON THE DEVICE. IN CONCLUSION, THE DEVICE'S MACHINE FLOW SENSOR AND SYSTEM PCA WERE REPLACED TO ADDRESS THE ISSUE. THE ROOT CAUSE IS CONFIRMED AT THIS TIME. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, THE BLOWER ASSEMBLY, BLOWER BELLOWS, BLOWER MOUNT, INTERNAL BATTERY DOOR, COOLING FAN ASSEMBLY, FAN RETAINER, HANDLE RETENTION PLATE, MUFFLER ASSEMBLY, AIR INLET FOAM FILTER, VANITY COVER ASSEMBLY, AND SYSTEM PCA TUBING WERE REPLACED ON THE DEVICE FOR AN UNSPECIFIED REASON BY THE THIRD-PARTY SERVICE TECHNICIAN. THIS WAS UNRELATED TO THE REPORTABLE ISSUE. THE DEVICE PASSED ALL FINAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25655360 ↗
• MalfunctionJun 27, 2026Device Sensing Problem

  A TRILOGY EVO LOANER VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. NO PATIENT INVOLVEMENT WAS REPORTED, AND NO HARM OR INJURY OCCURRED. DURING EVALUATION AT THE THIRD-PARTY SERVICE CENTER, A VENTILATOR INOPERATIVE ERROR WAS IDENTIFIED IN THE DEVICE EVENT LOG. THE ERROR INDICATED THAT THE AMOUNT OF FLUCTUATION IN THE FLOW SENSOR DEVIATED FROM THE ESTABLISHED STANDARD. DOCUMENTATION WAS NOT AVAILABLE TO IDENTIFY THE COMPONENTS REQUIRED TO ADDRESS THE ISSUE. NO REPAIR WAS PERFORMED. THE DEVICE WAS SUBSEQUENTLY CRUSHED AND DISPOSED OF. THEREFORE, NO FURTHER EVALUATION OR TESTING COULD BE CONDUCTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25647160 ↗
• MalfunctionJun 27, 2026Electrical /Electronic Property Problem

  A TRILOGY EVO LOANER VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. NO PATIENT INVOLVEMENT WAS REPORTED, AND NO HARM OR INJURY OCCURRED. DURING EVALUATION AT THE THIRD-PARTY SERVICE CENTER, A VENTILATOR INOPERATIVE ERROR WAS IDENTIFIED IN THE DEVICE EVENT LOG. THE ERROR INDICATED THAT THE AMOUNT OF FLUCTUATION IN THE FLOW SENSOR DEVIATED FROM THE ESTABLISHED STANDARD. DOCUMENTATION WAS NOT AVAILABLE TO IDENTIFY THE COMPONENTS REQUIRED TO ADDRESS THE ISSUE. NO REPAIR WAS PERFORMED. THE DEVICE WAS SUBSEQUENTLY CRUSHED AND DISPOSED OF. THEREFORE, NO FURTHER EVALUATION OR TESTING COULD BE CONDUCTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25647156 ↗
• MalfunctionJun 27, 2026Electrical /Electronic Property Problem

  A TRILOGY EVO LOANER VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. NO PATIENT INVOLVEMENT WAS REPORTED, AND NO HARM OR INJURY OCCURRED. DURING EVALUATION AT THE THIRD-PARTY SERVICE CENTER, A VENTILATOR INOPERATIVE ERROR WAS IDENTIFIED IN THE DEVICE EVENT LOG. THE ERROR INDICATED THAT THE AMOUNT OF FLUCTUATION IN THE FLOW SENSOR DEVIATED FROM THE ESTABLISHED STANDARD. DOCUMENTATION WAS NOT AVAILABLE TO IDENTIFY THE COMPONENTS REQUIRED TO ADDRESS THE ISSUE. NO REPAIR WAS PERFORMED. THE DEVICE WAS SUBSEQUENTLY CRUSHED AND DISPOSED OF. THEREFORE, NO FURTHER EVALUATION OR TESTING COULD BE CONDUCTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25647153 ↗
• MalfunctionJun 26, 2026Thermal Decomposition of Device; Adverse Event Without Identified Device or Use Problem

  A TRILOGY EVO DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR PREVENTATIVE MAINTENANCE. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. THE DEVICE WAS NOT IN PATIENT USE. THE EVALUATION IS STILL IN PROCESS BUT DISCOVERED THAT THE DEVICE HAD BLACK SMOKE ON THE MAIN HOUSING, OUTLET SIDE PANEL, AND REAR COVER. ADDITIONALLY, THE DEVICE HAD DIRT CONTAMINATION IN THE BLOWER ASSEMBLY, BLOWER BELLOW SEAL, BLOWER MOUNT, BLOWER CAP, BLOWER CHASSIS, COOLING FAN ASSEMBLY, AND FAN RETAINER. THE OTHER COMPONENTS HAD UNSPECIFIED CONTAMINATION, MACHINE FLOW SENSOR, PCA TUBING, BLOWER CHASSIS, FIO2 TUBING, AND LOW FLOW O2 TUBING. IN ADDITION, THE MUFFLER ASSEMBLY, AIR INLET FOAM FILTER, 3 WAY SOLENOID VALVE, AND PROPORTIONAL VALVES NEED TO BE REPLACED AS PART OF PREVENTIVE MAINTENANCE. 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 25633656 ↗
• MalfunctionJun 25, 2026Circuit Failure

  THE MANUFACTURER RECEIVED INFORMATION THAT A TRILOGY EVO VENTILATOR WAS RETURNED TO THE MANUFACTURER'S SERVICE CENTER FOR EVALUATION. THERE WAS NO PATIENT INVOLVEMENT, AND NO HARM OR INJURY REPORTED. ON EVALUATION, THE DEVICE WAS FOUND TO HAVE CORRUPTED DATA IN THE ELECTRONICALLY ERASABLE PROGRAMABLE READ-ONLY MEMORY ON THE SYSTEM/CENTRAL PROCESSING UNIT AS EVIDENCED BY VENTILATOR INOPERATIVE DEVICE ERROR CODE E-262. THE SYSTEM PRINTED CIRCUIT BOARD ASSEMBLY WOULD REQUIRE REPLACEMENT, HOWEVER, NO REPAIRS WERE COMPLETED. THE VENTILATOR WAS PROCESSED AS SCRAP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25620667 ↗
• MalfunctionJun 25, 2026Electrical /Electronic Property Problem; Device Sensing Problem

  THE MANUFACTURER RECEIVED INFORMATION THAT A TRILOGY EVO VENTILATOR INOPERATIVE ERROR CONDITION OCCURRED. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. THE DEVICE WAS NOT IN PATIENT USE. THE TRILOGY EVO WAS EVALUATED BY A THIRD-PARTY SERVICE CENTER, AND THE DEVICE EVALUATION FOUND A CRITICAL ERROR CODE INDICATING THE MACHINE FLOW SENSOR DRIFT ABOVE THE SPECIFICATION. THE DEVICE WAS SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25620017 ↗
• MalfunctionJun 25, 2026Electrical /Electronic Property Problem; Device Sensing Problem

  THE MANUFACTURER RECEIVED INFORMATION THAT A TRILOGY EVO VENTILATOR INOPERATIVE ERROR CONDITION OCCURRED. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. THE DEVICE WAS NOT IN PATIENT USE. THE TRILOGY EVO WAS EVALUATED BY A THIRD-PARTY SERVICE CENTER, AND THE DEVICE EVALUATION FOUND A CRITICAL ERROR CODE INDICATING THE MACHINE FLOW SENSOR DRIFT ABOVE THE SPECIFICATION. THE DEVICE WAS SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25620015 ↗
• MalfunctionJun 25, 2026Electrical /Electronic Property Problem; Device Sensing Problem

  THE MANUFACTURER RECEIVED A REPORT THAT A TRILOGY EVO VENTILATOR WAS RETURNED FOR SERVICE. NO PATIENT HARM OR INJURY WAS REPORTED. THE DEVICE WAS EVALUATED AT A THIRD-PARTY SERVICE CENTER, AND THE CUSTOMER COMPLAINT WAS CONFIRMED. INVESTIGATION IDENTIFIED A "VENT INOP" ALARM DUE TO THE MACHINE FLOW SENSOR DRIFT EXCEEDING SPECIFICATION LIMITS (>0.2LPM). THE FLOW SENSOR REQUIRED REPLACEMENT. NO REPAIR WAS PERFORMED. THE DEVICE WAS SUBSEQUENTLY DESTROYED AND DISPOSED OF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25620012 ↗
• MalfunctionJun 25, 2026Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION THAT A TRILOGY EVO VENTILATOR WAS RETURNED TO THE MANUFACTURER'S SERVICE CENTER FOR EVALUATION. THERE WAS NO PATIENT INVOLVEMENT, AND NO HARM OR INJURY REPORTED. ON EVALUATION, THE MACHINE FLOW SENSOR WAS FOUND TO HAVE HIGH DRIFT AS EVIDENCED BY VENTILATOR INOPERATIVE DEVICE ERROR CODE E-155. NO REPAIRS WERE COMPLETED. THE VENTILATOR WAS PROCESSED AS SCRAP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25619718 ↗
• MalfunctionJun 25, 2026Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION THAT A TRILOGY EVO VENTILATOR WAS RETURNED TO THE MANUFACTURER'S SERVICE CENTER FOR EVALUATION. THERE WAS NO PATIENT INVOLVEMENT, AND NO HARM OR INJURY REPORTED. ON EVALUATION, THE MACHINE FLOW SENSOR WAS FOUND TO HAVE HIGH DRIFT AS EVIDENCED BY VENTILATOR INOPERATIVE DEVICE ERROR CODE E-155. NO REPAIRS WERE COMPLETED. THE VENTILATOR WAS PROCESSED AS SCRAP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25619716 ↗