Trilogy Evo KR2110X15BRecalls & reported problems

Summary

The FDA's MAUDE database contains 466 adverse event reports that list this exact device (DI 00606959055483), received between May 26, 2021 and Sep 25, 2026 — classified as 3 deaths, 2 injuries, 461 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (216 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 16, 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 25, 2023Class IIOpen, Classified

   There are errors present in the Korean Instructions For Use where the word "invasive," was incorrectly translated to "noninvasive".

   Z-2106-2023 · 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 466 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026No Display/Image

  A Trilogy EVO was returned to the manufacturer's service center for evaluation. There was no harm or injury reported. The device was not in patient use. During the evaluation the device's display was found to be damaged and unable to be viewed. The device's display was replaced to address the issue. There were no actionable errors noted. The device was tested and passed all final testing.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50900871 ↗
• MalfunctionSep 25, 2026Circuit Failure; Battery Problem; No Tactile Prompts/Feedback

  A Trilogy EVO was returned to the manufacturer's 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 condition indicating the internal battery failed. The device's internal battery was replaced to address the issue. The device alarmed for ventilator inoperative alarms indicating communication failures. The system board was replaced to address the issues. The device alarmed indicating a touchscreen failure. The device's display board was replaced to address the issue. The device logs were not available; therefore, the date of the most recent error codes occurrence could not be determined. At this time, the reported error code event date is based solely on the customer's information received and has not been confirmed through device evaluation.Additionally, not related to the reportable issue, the device alarmed indicating a detachable battery failure. The device's detachable battery was replaced to address the issue. This would not affect therapy delivery. The blower assembly was found to have corrosion and was replaced. There was no allegation of blower failure. The device failed an a

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50900870 ↗
• MalfunctionSep 25, 2026Circuit Failure; Power Problem

  A Trilogy EVO was returned to the manufacturer's 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 condition indicating the AC power failed. The device logs were not available; therefore, the date of the most recent error codes occurrence could not be determined. At this time, the reported error code event date is based solely on the customer's information received and has not been confirmed through device evaluation. The device's power supply and system board were replaced to address the issue. The device was tested and passed all final testing.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50900375 ↗
• MalfunctionSep 25, 2026Electrical /Electronic Property Problem; Battery Problem

  A Trilogy EVO was returned to the manufacturer's 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 condition indicating the internal battery failed. The device logs were not available; therefore, the date of the most recent error codes occurrence could not be determined. At this time, the reported error code event date is based solely on the customer's information received and has not been confirmed through device evaluation. The device's internal battery was replaced to address the issue. Additionally, not related to the reportable issue, the device failed an FIO2 sensor receptacle verification test step. This test step verifies that the FIO2 solenoid is open, and the tubing is not kinked or occluded. This FIO2 sensor is used for monitoring purposes only. This would not affect the device's ability to deliver therapy as designed. There were no components documented replaced for this issue. The device was tested and passed all final testing.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50900374 ↗
• MalfunctionSep 25, 2026Electrical /Electronic Property Problem; Power Problem

  The manufacturer received information alleging a ventilator service required 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 manufacturer service center for evaluation, and the customer¿s complaint was confirmed. During the evaluation it was noted that there were intermittent AC power disconnection notifications are appearing on the device. The service technician evaluated and determined that the power supply was required for this issue. In conclusion, the device's power supply was replaced to address the issue. The root cause is confirmed at this time. Additionally, during the service of the device, the muffler assembly and air inlet foam filter 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 50899199 ↗
• MalfunctionSep 25, 2026Circuit Failure; Electrical /Electronic Property Problem

  A Trilogy Evo, Korea device was returned to a third-party service center for evaluation due to a service required message. There was no allegation of device malfunction, and the device was not reported to have been in patient use.During evaluation of the device, the service technician confirmed that error EVT_COMMSFAIL_UI_TO_TPY (error code 196) was found in the device error code log, and the System Printed Circuit Assembly (PCA) was replaced to address this error code.Additionally, the evaluation of the device data identified unrelated error codes. These error codes are consistent with normal device operation and expected use conditions and are not considered reportable under medical device reporting requirements. No evidence was identified to suggest that these error codes contributed to or caused the reported event. Due to 4-year PM assessment, the muffler assembly and air inlet foam filter were replaced. After the evaluation and rework were complete, the device passed final testing.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50897434 ↗
• MalfunctionSep 25, 2026Electrical /Electronic Property Problem; Battery Problem

  A Trilogy Evo, Korea device was returned to a third-party service center for evaluation due to a service required message. There was no allegation of device malfunction, and the device was not reported to have been in patient use.During evaluation of the device, the service technician confirmed that error EVT_BATTERY_NOT_CHARGING_FAULT (error code 59) was found in the device error code log, and the internal battery pack was replaced to address this error code.Additionally, the muffler assembly and air inlet foam filter were replaced due to 4-year PM assessment. After the evaluation and rework were complete, the device passed final testing.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50897199 ↗
• MalfunctionSep 25, 2026Circuit Failure; Electrical /Electronic Property Problem

  A Trilogy Evo, Korea device was returned to a third-party service center for evaluation due to a service required alarm. There was no allegation of device malfunction, and the device was not reported to have been in patient use.During evaluation of the device, the service technician confirmed that error EVT_TPY_HELD_IN_BM (error code 156) was found in the device error code log, and the System Printed Circuit Assembly (PCA) was replaced to address this error code.Additionally, the evaluation of the device data identified unrelated error codes. These error codes are consistent with normal device operation and expected use conditions and are not considered reportable under medical device reporting requirements. No evidence was identified to suggest that these error codes contributed to or caused the reported event. The in-line filter prox was also replaced due to dust contamination. Due to 4-year PM assessment, the muffler assembly and air inlet foam filter were replaced. After the evaluation and rework were complete, the device passed final testing.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50897197 ↗
• MalfunctionSep 24, 2026Electrical /Electronic Property Problem; Device Sensing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50890322 ↗
• MalfunctionSep 24, 2026Electrical /Electronic Property Problem; Device Sensing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50890319 ↗
• MalfunctionSep 24, 2026Electrical /Electronic Property Problem; Device Sensing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50890314 ↗
• MalfunctionSep 24, 2026Electrical /Electronic Property Problem; Battery Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50890312 ↗
• MalfunctionSep 24, 2026Circuit Failure; Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50890102 ↗
• MalfunctionSep 24, 2026Electrical /Electronic Property Problem; Battery Problem

  The manufacturer received information that a Trilogy Evo ventilator was returned to the manufacturer service center for evaluation. There was no patient involvement, and no harm or injury reported.On evaluation, ventilator service required event was noted in the event log indicating failure of the internal lithium-ion battery and required replacement. After battery replacement the device passed final tesing.Additional findings not related to the malfunction/issue: dust contamination was noted on the machin flow sensor; the machine flow sensor was replaced.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50886296 ↗
• MalfunctionSep 24, 2026Failure to Charge

  The manufacturer received information alleging that the ventilator displayed a Service Required alarm and experienced poor charging. There was no serious patient harm or injury that occurred or was reported. The Trilogy Evo was returned and evaluated by Philips engineer. The device evaluation confirmed that when connected to Alternating Current (AC) power, the power LED light does not turn on, and the battery did not charge. Replacement of the power supply was required to address the condition.In addition, the event logs were reviewed and confirmed the service required alarm for error code 201-EVT_POWER_BUZZER_FAIL, indicating possible no sound from buzzer at start and replacement of the buzzer was required. Following completion of the required service activities, the device passed final testing.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50886093 ↗
• MalfunctionSep 24, 2026No Display/Image; Electrical /Electronic Property Problem

  The manufacturer received information that a Trilogy Evo ventilator was returned to the manufacturer service center for evaluation. There was no patient involvement, and no harm or injury reported.On device evaluation, a ventilator service required alarm was confirmed in the event log indicating the backlight is blank in any state other than ¿off¿. Therapy will still be provided based on current settings. Will not be able to modify the settings (E-304). The issue required replacement of the display to resolve the issue. Preventative maintenance was completed. The device passed final testing after repair.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50886092 ↗
• MalfunctionSep 24, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50885317 ↗
• MalfunctionSep 24, 2026Failure to Calibrate; Device Sensing Problem

  The manufacturer received information alleging a ventilator required service. There was no harm or injury reported. The device was not in patient use. During the evaluation of the device at the manufacturer's service center, review of the ventilator logs found error code 384- EVT_PRESS_SENSOR_MISMATCH, indicating that the device software has detected a large pressure drop between the monitor and outlet pressure sensors. The device's two in-line filter, Prox and FIO2 tubbing were found to be contaminated with dust and were replaced to address the issues. In addition, Internal corrosion and contamination were also identified on the blower, requiring replacement of the blower assembly. As part of the required four-year preventive maintenance assessment, the inlet foam filter and muffler assembly were replaced. Following completion of the required service activities, the device passed final functional testing.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50883941 ↗
• MalfunctionSep 24, 2026Failure to Power Up

  The device was returned to the manufacture for periodic maintenance. There was no serious patient harm or injury that occurred or was reported. The Trilogy Evo was returned and evaluated by Philips engineer. The device evaluation found that the power light on the equipment did not come on. The power supply was replaced to address the issue. During preventative maintenance, the air inlet foam filter and muffler assembly were also replaced. The device passed functional testing after repair and was returned to the customer.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50883133 ↗
• MalfunctionSep 24, 2026Power Problem

  A Trilogy EVO ventilator was returned to the manufacturer service center for evaluation following a Vent Service Required alarm associated with an AC power fault. There was no harm or injury reported. There was no documentation indicating that the device was in patient use at the time of the event.During the evaluation, the reported issue was confirmed and an AC power supply fault was identified. The AC power supply was replaced to address the malfunction. The machine flow sensor was also found to be contaminated with dust and was replaced. As part of the scheduled four-year preventive maintenance assessment, the inlet filter and muffler assembly were replaced. The valve and internal/detachable batteries were assessed and found to be functioning normally. Following service, the device passed final testing.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50882461 ↗
• MalfunctionJun 30, 2026Electrical /Electronic Property Problem; Device Sensing Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR SERVICE REQUIRED ALARM 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 MANUFACTURER SERVICE CENTER FOR EVALUATION, AND THE CUSTOMER¿S COMPLAINT WAS CONFIRMED. DURING THE EVALUATION IT WAS NOTED THAT AN ERROR CODE, EVENT AEV FAILURE, WAS OBSERVED ON THE DEVICE'S ERROR LOG. THE SERVICE TECHNICIAN EVALUATED AND DETERMINED THE ACTIVE EXHALATION CONTROL MODULE (AECM OR PROPORTIONAL VALVE) HAD CAUSED THE VENTILATOR SERVICE REQUIRED ALARM ON THE DEVICE. IN CONCLUSION, THE DEVICE'S THE AECM WAS REPLACED TO ADDRESS THE ISSUE. THE ROOT CAUSE IS CONFIRMED AT THIS TIME. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, THE BLOWER AND INLINE PROXIMAL FILTER WERE REPLACED FOR CONTAMINATION UNRELATED TO THE REPORTABLE ISSUE. THE BLOWER CAP WAS REPLACED FOR PHYSICAL DAMAGE UNRELATED TO THE REPORTABLE ISSUE. THE DEVICE PASSED ALL FINAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25670104 ↗
• MalfunctionJun 30, 2026Electrical /Electronic Property Problem; Device Sensing Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE ALARM 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 MANUFACTURER SERVICE CENTER FOR EVALUATION, AND THE CUSTOMER¿S COMPLAINT WAS CONFIRMED. DURING THE EVALUATION IT WAS NOTED THAT AN ERROR CODE, MACHINE FLOW DRIFT HIGH, WAS OBSERVED ON THE DEVICE'S ERROR LOG. THE SERVICE TECHNICIAN EVALUATED AND DETERMINED THE MACHINE FLOW SENSOR HAD FAILED CAUSING THE ISSUE 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 SYSTEM PRINTED CIRCUIT ASSEMBLY WAS REPLACED FOR ERROR CODES, DRIFT DEBUG AND MOTOR CONTROLLER FORCE SHUTDOWN, THAT WERE OBSERVED ON THE DEVICE'S ERROR LOG. THIS WAS UNRELATED TO THE REPORTABLE ISSUE. THE MUFFLER ASSEMBLY, AIR INLET FOAM FILTER WAS REPLACED FOR PREVENTATIVE MAINTENANCE UNRELATED TO THE REPORTABLE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25669111 ↗
• MalfunctionJun 30, 2026Electrical /Electronic Property Problem; Device Sensing Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR SERVICE REQUIRED ALARM 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 MANUFACTURER SERVICE CENTER FOR EVALUATION, AND THE CUSTOMER¿S COMPLAINT WAS CONFIRMED. DURING THE EVALUATION IT WAS NOTED THAT AN ERROR CODE, EVENT AEV FAILURE, WAS OBSERVED ON THE DEVICE'S ERROR LOG. THE SERVICE TECHNICIAN EVALUATED AND DETERMINED THE ACTIVE EXHALATION CONTROL MODULE (AECM) HAD CAUSED THE ISSUE TO OCCUR ON THE DEVICE. IN CONCLUSION, THE AECM WAS REPLACED TO ADDRESS THE ISSUE. THE ROOT CAUSE IS CONFIRMED AT THIS TIME. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, THE SYSTEM PRINTED CIRCUIT ASSEMBLY WAS REPLACED TO ADDRESS ANOTHER ERROR CODE, PROXIMAL PRESSURE RAILED LOW, THAT WAS OBSERVED ON THE DEVICE'S ERROR LOG. THIS WAS UNRELATED TO THE REPORTABLE ISSUE. THE INLINE PROXIMAL FILTER WAS REPLACED FOR A FAILED FIO2 RECEPTACLE VERIFICATION TEST STEP THAT OCCURRED DURING DIAGNOSTIC TESTING. THIS WAS UNRELATED TO THE REPORTABLE ISSUE. THE MUFFLER ASSEMBLY AND AIR INLET FOAM FILTER WERE REPLACED FOR PREVENTATIVE MAINTENANCE UNRELATED TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25668858 ↗
• MalfunctionJun 30, 2026Electrical /Electronic Property Problem; Mechanical Problem; Device Sensing Problem; Device Contamination with Chemical or Other Material

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR SERVICE REQUIRED ALARM 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 WAS RETURNED TO THE MANUFACTURER SERVICE CENTER FOR EVALUATION, AND THE CUSTOMER¿S COMPLAINT WAS CONFIRMED. DURING THE EVALUATION IT WAS NOTED THAT AN ERROR CODE, PRESSURE SENSOR MISMATCH, WAS OBSERVED ON THE DEVICE'S ERROR LOG. THE SERVICE TECHNICIAN EVALUATED AND DETERMINED THAT THERE WAS CONTAMINATION FOUND ON THE MACHINE FLOW SENSOR, BLOWER, AND INLINE PROXIMAL FILTER HAD CAUSED THE VENTILATOR SERVICE REQUIRED ALARM TO OCCUR ON THE DEVICE. IN CONCLUSION, THE DEVICE'S MACHINE FLOW SENSOR, INLINE PROXIMAL FILTER, AND BLOWER ASSEMBLY WERE REPLACED TO ADDRESS THE ISSUE. THE ROOT CAUSE IS CONFIRMED AT THIS TIME. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, THE MUFFLER, AND AIR INLET FOAM FILTER WERE REPLACED FOR PREVENTATIVE MAINTENANCE UNRELATED TO THE REPORTABLE MALFUNCTION/ISSUE. THE DEVICE PASSED ALL FINAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25668838 ↗
• MalfunctionJun 30, 2026Circuit Failure; Electrical /Electronic Property Problem; Failure to Calibrate; Device Sensing Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE AND VENTILATOR SERVICE REQUIRED ALARMS 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 MANUFACTURER SERVICE CENTER FOR EVALUATION, AND THE CUSTOMER¿S COMPLAINT WAS CONFIRMED. DURING THE EVALUATION IT WAS NOTED THAT AN ERROR CODE, MACHINE FLOW DRIFT HIGH, WAS OBSERVED ON THE DEVICE'S ERROR LOG. THE SERVICE TECHNICIAN EVALUATED AND DETERMINED THE MACHINE FLOW SENSOR HAD CAUSED THE VENTILATOR INOPERATIVE ALARM TO OCCUR ON THE DEVICE. AN ADDITIONAL ERROR CODE, INTERNAL BATTERY NOT DETECTED, WAS OBSERVED ON THE DEVICE'S ERROR LOG FOR THE VENTILATOR SERVICE REQUIRED WAS OBSERVED ON THE DEVICE'S ERROR LOG. THE SERVICE TECHNICIAN EVALUATED AND DETERMINED THE SYSTEM PRINTED CIRCUIT ASSEMBLY (PCA) HAD CAUSED THE VENTILATOR SERVICE REQUIRED ALARM TO OCCUR ON THE DEVICE. THE SERVICE TECHNICIAN OBSERVED ANOTHER REPORTABLE ERROR CODE, TOUCHSCREEN FAILED, ON THE DEVICE'S ERROR LOG. THE SERVICE TECHNICIAN EVALUATED AND DETERMINED THE SYSTEM PCA HAD CAUSED THIS ERROR CODE TO OCCUR ON THE DEVICE. THE SERVICE TECHNICIAN PERFORME

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25668578 ↗