Trilogy Evo, Japan JP2110X16BRecalls & reported problems

Summary

The FDA's MAUDE database contains 1,112 adverse event reports that list this exact device (DI 00606959051973), received between Nov 2, 2021 and Sep 30, 2026 — classified as 27 deaths, 47 injuries, 1,038 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (416 reports).

5 FDA recall records name this device's identifier, 5 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Oct 7, 2024Class IOpen, Classified

   Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could lead to inaccurate flow measurements.

   Z-0291-2025 · Root cause: Device Design · Recall details · FDA record ↗

2. Jul 16, 2024Class IOpen, Classified

   Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for affected ventilators. These updates resolve safety issues identified in earlier recalls.

   Z-2944-2024 · Root cause: Device Design · Recall details · FDA record ↗

3. Mar 19, 2024Class IOpen, Classified

   Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.

   Z-1504-2024 · Root cause: Device Design · Recall details · FDA record ↗

4. Nov 27, 2023Class IIOpen, Classified

   The following was missing from the Contraindications Statement: The AVAPS-AE therapy mode is contraindicated for invasive use and patients less than 10 kg. The AVAPS feature is contraindicated for patients less than 10 kg. Potential harms if devices are used on contraindicated patients include barotrauma, hypoventilation/hypercapnia, and rebreathing of excessive CO2.

   Z-0638-2024 · Root cause: Device Design · Recall details · FDA record ↗

5. May 1, 2023Class IOpen, Classified

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

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

Most reported problems

Recent adverse event reports

The 25 most recent of 1,112 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Electrical /Electronic Property Problem; Device Sensing Problem

  The manufacturer received a report from a customer that a Trilogy Evo ventilator was experiencing frequent ¿Ventilator Service Required¿ alarms. No patient harm or injury was alleged in association with the reported condition.The device was replaced and evaluated. During the operational check, the reported ¿Ventilator Service Required¿ alarm was reproduced. Review of the device logs identified error code 385-EVT_MACH_FLOW_DRFT_VSR, indicating that the amount of variation in the flow sensor had deviated from specification. The flow sensor was replaced. Dirt was also observed within the airflow path during the evaluation. Additionally, the 3-way solenoid valve was replaced after the cable was found to have been damaged by being caught in the device cover. No thermal damage or exposed wiring was observed.Following the repairs, the device successfully completed the final test, battery check, valve check, and run-in testing. The device was cleaned and confirmed to be operating properly. The device software version was confirmed to be 1.06.15.00.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950010 ↗
• MalfunctionSep 30, 2026Circuit Failure; Electrical /Electronic Property Problem

  The manufacturer received information alleging a Trilogy EVO alarmed for a ventilator inoperative alarm condition upon start up. There was no harm or injury reported. The device had not yet been placed in patient use. The device was returned to the manufacturer's service center and the customer's complaint was confirmed. A ventilator inoperative alarm indicating the EEPROM data on the system board was corrupt was observed in the device's downloaded event log. The device's system board was replaced to address the issue. Additionally, not related to the reportable issue, the device's air inlet foam filter and particulate filter were replaced preventatively. The device was cleaned and tested and passed all final testing.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948688 ↗
• MalfunctionSep 30, 2026Mechanical Problem; Failure to Calibrate

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948686 ↗
• MalfunctionSep 29, 2026Power Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50938020 ↗
• MalfunctionSep 29, 2026Output Problem; Key or Button Unresponsive/not Working

  The manufacturer received information that on 02SEP2026 a visiting nurse reported that the Trilogy Evo ventilator¿s alarm silence button/touch panel was unresponsive. The representative guided the patient¿s mother through a forced shutdown and restart, but the touch panel remained unresponsive, preventing ventilation from being started. The mother was instructed to use an Ambu bag and call emergency services if the patient¿s condition worsened. The representative visited the home and replaced the device with another unit of the same model, but its touch panel was also unresponsive. A visiting nurse subsequently assessed the patient, checked the device settings and alarms, and measured vital signs. No patient harm or ongoing equipment issues were identified, and the representative left the home.The device was returned to a service center for evaluation. The evaluation found that the reported issue was not duplicated by operational checking. The event log showed repeated E192 (sound silence button pressed) events, but E190 (sound silencing executed) was not recorded, indicating that the sound was not silenced and the issue was attributed to a software failure. The touch panel not res

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50930115 ↗
• MalfunctionSep 28, 2026Computer Software Problem; Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50921543 ↗
• MalfunctionSep 28, 2026Circuit Failure; Electrical /Electronic Property Problem

  The manufacturer received a report that a Trilogy EVO ventilator was returned for preventive maintenance. No patient harm or injury was reported.The device was returned to the manufacturer's service center for evaluation. The device error logs were successfully downloaded and reviewed in full. Analysis identified an issue with the SuperCap or the charging unit. The issue was resolved by replacing the System Printed Circuit Assembly (PCA). The service technician performed final testing, battery check, valve check, run in tests, and cleaning. The unit was confirmed to be operating properly. The software version was upgraded from 1.06.10.00 to 1.06.15.00.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50913689 ↗
• MalfunctionSep 25, 2026Electrical /Electronic Property Problem; Battery Problem; Computer Operating System Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50902453 ↗
• MalfunctionSep 25, 2026Electrical /Electronic Property Problem; Device Sensing Problem

  A Trilogy Evo device had a ventilator service required alarm while in patient use. There is no allegation of serious or permanent harm or injury.The device was returned to the manufacturer for evaluation. During the evaluation, it was noted that error code E385 (EVT_MACH_FLOW_DRIFT_VRS) was found in the device log. This error indicates that the flow sensor had experienced drift exceeding specifications. The system Printed Circuit Assembly (PCA) that performs flow sensor signal processing and drift determination was replaced to address the issue.Additionally, no dirt was found on the airflow path at that time. Performed Final Test, battery check, valve check, run in tests and cleaning then confirmed the unit operated properly. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50895939 ↗
• MalfunctionSep 24, 2026Circuit Failure; Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50889547 ↗
• MalfunctionSep 24, 2026Circuit Failure; Obstruction of Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50884603 ↗
• MalfunctionSep 24, 2026Circuit Failure; Charging Problem

  A Trilogy EVO was returned to the manufacturer for preventive maintenance. There was no harm or injury reported. The device was not in patient use. During the evaluation an alarm indicating the supercap failed causing the device to fail to charge was observed in the device's downloaded event log. The device's system board was replaced to address the issue. Additionally, not related to the reportable issue, the blower assembly, system board tubing and low flow O2 tubing were replaced due to dirt contamination. The device's air inlet foam filter, particulate filter and muffler assembly were replaced preventatively. The device was cleaned and tested and passed all final testing.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50884109 ↗
• MalfunctionSep 16, 2026Electrical /Electronic Property Problem; Power Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50788598 ↗
• DeathSep 15, 2026Misconnection

  Patient problems: Insufficient Information

  MAUDE report 50771548 ↗
• MalfunctionSep 2, 2026Thermal Decomposition of Device; Circuit Failure; Power Problem

  A Trilogy EVO Ventilator was returned to the manufacturer service center for preventative maintenance. The device was not in use on a patient at the time of the occurrence.During the evaluation the AC power was not recognized therefore the power supply was replaced to resolve the issue. During the final test thermal damage was observed on the AC power cord therefore, the System Board was replaced to address the issue. Additionally, during the evaluation the device failed a FIO2 Sensor Receptacle Verification test step during testing unrelated to the identified malfunction, therefore, the inline proximal filter was replaced to address the issue. Periodic maintenance 2 was performed. The following parts were replaced to prevent failure: air inlet foam filter muffler assembly and particulate filter. The technician performed Final Test, battery check, valve check, run in tests and cleaning then confirmed the unit operated properly. The Software version was upgraded from 1.06.10.00 to 1.06.15.00.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50569638 ↗
• MalfunctionAug 27, 2026Electrical /Electronic Property Problem; Device Sensing Problem

  The manufacturer received information alleging a patient experienced a Ventilator Required alarm while using a Trilogy EVO ventilator. There was no report of patient harm or injury.The Trilogy EVO ventilator was returned to the manufacturer service center for evaluation, and the customer¿s complaint was confirmed. During the evaluation an error code indicating MACH_FLOW_DRIFT_VSR was observed in the device event log. While being tested on a Service Diagnostic Test Tool, the issue no longer occurred. There was no dirt on the flow sensor confirmed during a visual inspection. The issue was not confirmed, but the technician states the possibility of a flow sensor malfunction cannot be denied, so the flow sensor was replaced as a preventive measure. The root cause isn't confirmed at this time. Additionally, the technician performed Final Test, battery check, valve check, run in tests and cleaning then confirmed the unit operated properly. The software version was confirmed (1.06.15.00).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50470554 ↗
• DeathAug 5, 2026Adverse Event Without Identified Device or Use Problem

  It was reported by the (b)(6) that the patient died on (b)(6) 2026 after a Trilogy EVO device had been on standby for about an hour. The patient had reportedly been using the mask for 24 hours, and it was reported that the patient became unresponsive at around 16:55. The patient was already unresponsive when the ambulance crew arrived. It was reportedly determined that transportation was not necessary, and the patient was pronounced deceased at the scene. As the death was confirmed by emergency medical personnel, the cause of death and the estimated time of death were still under investigation. Upon review of the trend data from the police, the waveform was interrupted approximately from 15:50 to 16:45. Since there was a period in which no waveform was recorded in the trend Data, it is presumed that the patient may not have received ventilation for approximately one hour, which may have contributed to the death.Regarding the device, it was reported that the case was being handled as a police matter and that the device would also be examined at the police station. Therefore, it was unclear when the device could be returned to Philips. According to the detective's impression, the de

  Patient problems: Insufficient Information

  MAUDE report 50143901 ↗
• MalfunctionJun 30, 2026Power Problem

  THE TRILOGY EVO VENTILATOR WAS RETURNED TO THE MANUFACTURER SERVICE CENTER FOR PREVENTATIVE MAINTENANCE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. DURING THE EVALUATION IT WAS NOTED THAT THE DEVICE DOES NOT RECOGNIZE AC POWER SOURCE THEREFORE THE POWER SUPPLY WAS REPLACED TO RESOLVE THE ISSUE. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, PERIODIC MAINTENANCE 2 WAS PERFORMED AND THE AIR INLET FOAM FILTER, PARTICULATE FILTER AND MUFFLER ASSEMBLY WERE REPLACED TO PREVENT FAILURE. THE TECHNICIAN PERFORMED FINAL TEST, BATTERY CHECK, VALVE CHECK, RUN IN TESTS AND CLEANING THEN CONFIRMED THE UNIT OPERATED PROPERLY. THE SOFTWARE VERSION WAS UPGRADED TO 1.06.15.00 FROM 1.06.10.00.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25664750 ↗
• MalfunctionJun 30, 2026Circuit Failure; Power Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A TRILOGY EVO WAS ALARMING FOR A SERVICE REQUIRED ALARM CONDITION. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS NOT IN PATIENT USE. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S SERVICE CENTER FOR EVALUATION AND THE CUSTOMER'S COMPLAINT WAS CONFIRMED. A SERVICE REQUIRED ALARM INDICATING AND AC POWER FAILURE WAS OBSERVED IN THE DEVICE'S DOWNLOADED EVENT LOG. THE DEVICE'S POWER SUPPLY AND SYSTEM BOARD WERE REPLACED TO ADDRESS THE ISSUE. THE DEVICE WAS CLEANED AND TESTED AND PASSED ALL FINAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25664129 ↗
• MalfunctionJun 29, 2026Circuit Failure; No Tactile Prompts/Feedback

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A TRILOGY EVO'S TOUCHSCREEN FAILED TO RESPOND. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS NOT IN PATIENT USE. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S SERVICE CENTER AND THE CUSTOMER'S COMPLAINT WAS CONFIRMED. THE DEVICE'S DISPLAY BOARD AND DISPLAY SCREEN WERE REPLACED TO ADDRESS THE ISSUE. THE DEVICE WAS CLEANED AND TESTED AND PASSED ALL FINAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25655381 ↗
• MalfunctionJun 29, 2026Circuit Failure

  THE MANUFACTURER RECEIVED INFORMATION THAT A TRILOGY EVO VENTILATOR WAS RETURNED TO THE MANUFACTURER'S SERVICE CENTER FOR EVALUATION FOR THE ALLEGATION THAT THE TURNED RED AND THE DEVICE WAS INOPERATIVE. THERE WAS NO PATIENT INVOLVEMENT, AND NO HARM OR INJURY REPORTED. ONE EVALUATION, IMMEDIATELY AFTER POWERING ON THE UNIT, THE REPORTED ¿VENTILATOR INOPERATIVE¿ ALARM WAS DUPLICATED. REVIEW OF THE ERROR LOG CONFIRMED THE OCCURRENCE OF VENTILATOR INOPERATIVE ERROR CODE E-262, WHICH IS RECORDED WHEN THE ELECTRONICALLY ERASABLE PROGRAMABLE READ-ONLY MEMORY (EEPROM) DATA ON THE SYSTEM PRINTED CIRCUIT BOARD ASSEMBLY (PCA) BECOMES CORRUPTED. THEREFORE, THE SYSTEM PCA CONTAINING THE EEPROM WAS REPLACED. ADDITIONAL FINDINGS NOT RELATED TO THE MALFUNCTION/ISSUE: THE FOLLOWING PARTS WERE REPLACED TO PREVENT FAILURE: AIR INLET FOAM FILTER, PARTICULATE FILTER, MUFFLER ASSEMBLY. SOFTWARE VERSION WAS UPGRADED FROM 1.06.10.00 TO 1.06.15.00. THE DEVICE PASSED FINAL TESTING AND WAS CONFIRMED TO OPERATE PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25654132 ↗
• MalfunctionJun 26, 2026Electrical /Electronic Property Problem; Device Sensing Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE" ALARM OCCURRED ON A TRILOGY EVO VENTILATOR. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. THE TRILOGY EVO VENTILATOR WAS RETURNED TO THE MANUFACTURER SERVICE CENTER FOR EVALUATION, AND THE CUSTOMER¿S COMPLAINT WAS CONFIRMED. DURING THE EVALUATION AN ERROR CODE IN RELATION TO MACHINE FLOW SENSOR DRIFT ABOVE THE SPECIFICATION (GREATER THEN 0.2LPM) WAS RECORDED IN THE DEVICE EVENT LOG. IN CONCLUSION, THE DEVICE'S MACHINE FLOW SENSOR WAS REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, DURING THE EVALUATION, THE SILVER FRAME AROUND THE MUTE BUTTON WAS FOUND TO BE MISSING THEREFORE THE VANITY COVER WAS REPLACED. THE SOFTWARE WAS UPGRADED FROM 1.06.10.00 TO 1.06.15.00. THE TECHNICIAN PERFORMED A FINAL TEST, BATTERY CHECK, VALVE CHECK, RUNNING TEST, AND CLEANING WERE PERFORMED TO CONFIRM NORMAL OPERATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25636869 ↗
• MalfunctionJun 25, 2026Electrical /Electronic Property Problem; Battery 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. DURING THE EVALUATION IT WAS NOTED THAT AN ERROR CODE, INTERNAL BATTERY COMMUNICATION FAILED, WAS OBSERVED ON THE DEVICE'S ERROR LOG. THE SERVICE TECHNICIAN FURTHER EVALUATED AND DETERMINED THE INTERNAL BATTERY HAD CAUSED THE VENTILATOR SERVICE REQUIRED ALARM TO OCCUR ON THE DEVICE. IN CONCLUSION, THE INTERNAL BATTERY WAS REPLACED TO ADDRESS THE ISSUE. THE ROOT CAUSE IS CONFIRMED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25624837 ↗
• InjuryJun 25, 2026Display or Visual Feedback Problem

  THE MANUFACTURER RECEIVED A REPORT FROM THE PATIENT'S FAMILY INDICATING THAT AN ATTEMPT WAS MADE TO SWITCH THE SETTINGS ON A TRILOGY EVO VENTILATOR TO THE SECONDARY SETTINGS DUE TO DETERIORATION IN THE PATIENT'S CLINICAL CONDITION; HOWEVER, THE SETTINGS COULD NOT BE CHANGED. THE DEVICE WAS EXPECTED TO BE OPERATING IN THE SECONDARY SETTINGS CONFIGURATION BUT WAS FOUND TO BE IN THE NIGHT SETTINGS CONFIGURATION. WHEN AN ATTEMPT WAS MADE TO SWITCH SETTINGS, A MESSAGE WAS DISPLAYED INDICATING THAT A COMPATIBLE CIRCUIT WAS REQUIRED FOR THE SELECTED SETTINGS, AND THE CHANGE COULD NOT BE COMPLETED. DUE TO THE PATIENT'S WORSENING CONDITION, EMERGENCY MEDICAL SERVICES WERE CONTACTED. AT APPROXIMATELY 23:55, THE SALES REPRESENTATIVE CONTACTED THE PATIENT'S FAMILY AND WAS INFORMED THAT AN AMBULANCE WAS CALLED. THE FAMILY WAS REPORTED TO BE IN A HIGHLY AGITATED STATE, AND A REPRIMAND WAS RECEIVED IN A STRONG TONE, STATING, "WHAT ARE YOU GOING TO DO ABOUT THIS." THEN, THE CALL WAS UNILATERALLY TERMINATED. IN CONSIDERATION OF THE FACT THAT EMERGENCY SERVICES HAD BEEN REQUESTED AND THE FAMILY WAS DISTRESSED, NO ADDITIONAL CONTACT WAS MADE ON THAT DATE. ON JUNE 12, 2026, ADDITIONAL INFORMATION REGA

  Patient problems: Pneumothorax

  MAUDE report 25621971 ↗
• MalfunctionJun 25, 2026Circuit Failure; Electrical /Electronic Property Problem; Device Sensing Problem

  THE MANUFACTURER RECEIVED A REPORT THAT A TRILOGY EVO VENTILATOR DISPLAYED A "VENTILATOR SERVICE REQUIRED" ALARM. THE PATIENT REPORTED THE ALARM OCCURRENCE, AND REVIEW OF THE DEVICE ALARM/EVENT LOGS CONFIRMED THAT THE ALARM OCCURRED AT APPROXIMATELY 14:30. A SALES REPRESENTATIVE VISITED THE PATIENT'S RESIDENCE AND REPLACED THE DEVICE WITH ANOTHER TRILOGY EVO VENTILATOR. REVIEW OF THE ALARM HISTORY CONFIRMED THE REPORTED ALARM CONDITION. IT WAS FURTHER REPORTED THAT THE "VENTILATOR SERVICE REQUIRED" ALARM HAD OCCURRED MULTIPLE TIMES PER MONTH. FOLLOW-UP WITH THE PATIENT'S FAMILY REGARDING DEVICE USAGE INDICATED THAT THE VENTILATOR WAS FREQUENTLY PLACED IN STANDBY MODE. ADDITIONALLY, IT WAS REPORTED THAT THE FREQUENCY OF ALARM OCCURRENCES HAD INCREASED FOLLOWING A RECENT SOFTWARE UPDATE; NO SIMILAR ALARMS HAD BEEN OBSERVED WITH THE PREVIOUS SOFTWARE VERSION. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR INVESTIGATION. DURING AN OPERATIONAL CHECK, THE REPORTED ISSUE WAS CONFIRMED. THE DEVICE ERROR LOG WAS DOWNLOADED AND REVIEWED. ANALYSIS IDENTIFIED A "VENTILATOR SERVICE REQUIRED" ERROR GENERATED WHEN THE DEVICE SOFTWARE DETECTED A MACHINE FLOW SENSOR DRIFT EXCEEDING 0.2 SLPM. AS PA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25621605 ↗