Trilogy Evo, O2, Japan JP2100X16BRecalls & reported problems

Summary

The FDA's MAUDE database contains 342 adverse event reports that list this exact device (DI 00606959055582), received between Jul 7, 2021 and Sep 30, 2026 — classified as 5 deaths, 4 injuries, 333 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (120 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 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-0290-2025 · 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-1502-2024 · 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 ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 342 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 50948691 ↗
• MalfunctionSep 24, 2026Circuit Failure; Electrical /Electronic Property Problem; Failure to Calibrate

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50886988 ↗
• DeathAug 13, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  The manufacturer received information alleging a patient passed away on (b)(6) 2026. A clinical assessment was performed. On (b)(6) 2026, the patient was found deceased in the morning. Philips was contacted because there was concern that the device may have become disconnected during this period, and a request was made for detailed device logs, including power on/off times, alarm history, setting changes, and other operation records. Reported alarms during the event included Low Tidal Volume, Low Minute Ventilation, and Circuit Disconnect. A nurse noted that the ventilator was found disconnected at some point. It was reported that the cause was determined to be human error rather than a device-related issue. Based on the information currently provided and available, device cause and/or contribution to the reported event cannot currently be confirmed, nor refuted, based on the evidence present. The device evaluation has not yet begun. At this time, we are unable to confirm the alleged malfunction. If any additional information is received once the investigation is complete, a follow-up report will be filed.

  Patient problems: Insufficient Information

  MAUDE report 50239300 ↗
• MalfunctionJun 1, 2026Circuit Failure; Electrical /Electronic Property Problem; Mechanical Problem

  THE MANUFACTURER RECEIVED A REPORT THAT A TRILOGY EVO VENTILATOR EMITTED AN UNUSUALLY LOUD NOISE FROM THE REAR OF THE DEVICE. A SALES REPRESENTATIVE VISITED THE HOSPITAL TO EVALUATE THE ISSUE AND CONFIRMED THE ABNORMAL SOUND. THE CUSTOMER REPORTED THAT THE NOISE OCCURRED WHEN THE FIO2 SETTING WAS AT APPROXIMATELY 40% AND TYPICALLY CEASED WHEN THE FIO2 WAS INCREASED TO 60%. BASED ON THE EVALUATION, THE SOUND LEVEL WAS DETERMINED TO BE ABNORMAL, AND THE DEVICE WAS REPLACED. THE DEVICE WAS RETURNED TO THE MANUFACTURER SERVICE CENTER FOR EVALUATION. THE REPORTED ISSUE WAS CONFIRMED DURING TESTING. THE OXYGEN BLENDING MODULE (OBM) SUBASSEMBLY WAS REPLACED, AND SUBSEQUENT TESTING PERFORMED UNDER THE SAME OPERATING CONDITIONS DEMONSTRATED IMPROVEMENT OF THE ISSUE. BASED ON THE INVESTIGATION RESULTS, THE ISSUE WAS ATTRIBUTED TO A MALFUNCTION OF THE OBM SUBASSEMBLY. THE DEVICE LOG FILES WERE SUCCESSFULLY DOWNLOADED AND REVIEWED IN FULL. "VENT SERVICE REQUIRED" ALARMS WERE IDENTIFIED, INCLUDING ALARMS ASSOCIATED WITH CESSATION OF O2 FLOW COMMUNICATION IN WHICH THE SENSOR REPEATEDLY REPORTED THE SAME VALUE, AS WELL AS MONITOR PRESSURE SENSOR COMMUNICATION FAILURES IN WHICH THE SENSOR REMAINED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25354950 ↗
• MalfunctionJun 1, 2026Mechanical Problem

  THE MANUFACTURER RECEIVED INFORMATION THAT A TRILOGY EVO VENTILATOR WAS RETURNED TO THE MANUFACTURER'S SERVICE CENTER FOR EVALUATION FOR THE ALLEGATION THE OXYGEN REGULATION ALARM DID NOT SOUND WHEN THE HOSE WAS DETACHED AFTER OXYGEN WAS DELIVERED DURING A PERIODICAL DEVICE CHECK. . THERE WAS NO PATIENT INVOLVEMENT, AND NO HARM OR INJURY REPORTED. ON DEVICE EVALUATION, THE REPORTED ISSUE WAS NOT REPRODUCED. REVIEW OF THE DEVICE'S EVENT LOG CONFIRMED RECORD OF THE ALLEGED DEVICE ISSUE. THE DEVICE HAD VERIFICATION TESTING COMPLETED AND PASSED THE TESTING. AS A PREVENTATIVE MEASURE, THE OXYGEN BLENDING MODULE SUBASSEMBLY WAS REPLACED. FUNCTIONAL TESTING WITH ADDING OXYGEN WAS PERFORMED AFTER THE REPLACEMENT AND CONFIRMED THERE WERE NO ABNORMAL NOISES. ADDITIONALLY, IT WAS CONFIRMED THAT THE REPORTED ISSUE DID NOT OCCUR AFTER COMPONENT REPLACEMENT. THE DEVICE PASSED FINAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25350278 ↗
• MalfunctionMay 29, 2026Circuit Failure; No Display/Image

  THE MANUFACTURER RECEIVED INFORMATION FROM A NURSE ALLEGING THAT THE SCREEN SUDDENLY WENT DARK WHILE TOUCHING THE SCREEN TO CHECK SETTINGS ON A TRILOGY EVO DEVICE. THE NURSE STATED THAT THE SCREEN SWITCHED TO AN HOURGLASS WITH A BLUE BACKGROUND AFTER THAT, AND THE SCREEN REPEATEDLY BECAME COMPLETELY DARK. THE AIRFLOW KEPT BEING DELIVERED AT THIS TIME. THE AIRFLOW ALSO STOPPED WHILE ATTEMPTING TO TURN OFF THE POWER USING VARIOUS OPERATIONS, SUCH AS HOLDING THE BUTTON. THE NURSE INFORMED THE SALES REPRESENTATIVE THAT INITIALLY THERE WAS A YELLOW ALARM THAT SOUNDED CONSISTENTLY, AND A RED ALARM OCCURRED WHEN THE POWER CORD WAS UNPLUGGED FOR THE DEVICE REPLACEMENT. THE DEVICE WAS REPLACED WITH ANOTHER DEVICE. THERE WAS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS SPECIFIED BY THE PATIENT. THE TRILOGY EVO WAS RETURNED TO THE MANUFACTURER SERVICE CENTER FOR EVALUATION, AND THE CUSTOMER¿S COMPLAINT WAS CONFIRMED. DURING THE EVALUATION IT WAS NOTED THAT THE DEVICES DISPLAY PRINTED CIRCUIT ASSEMBLY (PCA) HAD CAUSED THE SCREEN TO GO DARK ON THE DEVICE. IN CONCLUSION, THE DEVICE'S DISPLAY PCA WAS REPLACED TO ADDRESS THE ISSUE. THE ROOT CAUSE IS CONFIRMED A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25337394 ↗
• MalfunctionMay 28, 2026Computer Software Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THAT DURING A PRE-USE CHECK OF A TRILOGY EVO O2 JAPAN VENTILATOR, A CONTINUOUS ALARM SOUNDED AND THE SCREEN FAILED TO START UP. BECAUSE THE SCREEN DID NOT DISPLAY, THE SPECIFIC ALARM CONDITION COULD NOT BE IDENTIFIED. THE DEVICE WAS NOT IN PATIENT USE AT THE TIME OF THE EVENT. NO PATIENT INJURY OR HARM WAS REPORTED. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. INVESTIGATION CONFIRMED THAT THE VENTILATOR POWERED UP IN A ¿VENTILATOR INOPERATIVE¿ ALARM STATE. REVIEW OF THE EVENT LOG IDENTIFIED AN ERROR CODE INDICATING THAT FLUCTUATION LEVELS DETECTED BY THE FLOW SENSOR DEVIATED FROM ESTABLISHED SPECIFICATIONS. RESTORATION PROCEDURES WERE PERFORMED USING DEDICATED SERVICE SOFTWARE, WHICH RESOLVED THE ISSUE. AS A PREVENTIVE MEASURE, THE DEVICE FLOW SENSOR WAS REPLACED. FINAL FUNCTIONAL TESTING, BATTERY CHECK, VALVE CHECK, RUN-IN TESTING, AND CLEANING WERE COMPLETED, AND THE DEVICE WAS CONFIRMED TO BE OPERATING PROPERLY. ADDITIONALLY, THE SOFTWARE WAS UPGRADED FROM VERSION 1.06.10.00 TO VERSION 1.06.15.00.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25326020 ↗
• MalfunctionMay 28, 2026Computer Software Problem; Electrical /Electronic Property Problem; Unexpected Shutdown

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THAT A TRILOGY EVO O2 JAPAN DEVICE STOPPED OPERATING WITH A VENTILATOR INOPERATIVE ALARM WHILE IN PATIENT USE. THE SALES REPRESENTATIVE POWERED ON THE DEVICE AND VERIFIED THAT THE DEVICE WOULD NOT OPERATE AND THAT THE SCREEN DISPLAYED RED. THE DEVICE WAS REPLACED. THE FAMILY REPORTED THAT THE ALARM OCCURRED WHEN THE DEVICE WAS POWERED OFF DURING AN OUTING. THERE WAS NO ALLEGATION OF HARM OR INJURY REPORTED. THE VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION, AND THE REPORTED ISSUE WAS CONFIRMED. EVALUATION DUPLICATED AN ERROR INDICATING THAT THE AMOUNT OF FLUCTUATION IN THE FLOW SENSOR DEVIATED FROM THE STANDARD. RESTORATION WORK WAS PERFORMED USING DEDICATED SOFTWARE, WHICH RESOLVED THE ISSUE. ADDITIONALLY, THE DEVICE'S FLOW SENSOR WAS REPLACED AS A PREVENTIVE ACTION. FINAL TESTING, BATTERY CHECK, VALVE CHECK, RUN-IN TESTING, AND CLEANING WERE PERFORMED, AND THE DEVICE WAS CONFIRMED TO OPERATE 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 25325838 ↗
• MalfunctionMay 27, 2026Contamination; Pressure Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE USB EXTEND CABLE IS CRUSHED AND A NOISE WAS HEARD FROM THE BLOWER. 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 THE MANUFACTURER'S SERVICE CENTER, AN ERROR CODE RELATED TO THE PRESSURE SENSOR WAS OBSERVED DURING AN OPERATIONAL CHECK. 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). DIRT CONTAMINATION WAS OBSERVED ON THE OXYGEN BLENDING MODULE (OBM) SUB-ASSEMBLY, SO THE DEVICES OBM SUB-ASSEMBLY WAS REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, UNRELATED TO THE ERROR CODE ISSUE, THE USB EXTENSION CABLE AND THE BLOWER ASSEMBLY WERE REPLACED TO ADDRESS THE INITIAL REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25302921 ↗
• MalfunctionMay 22, 2026Circuit Failure; Electrical /Electronic Property Problem; Unexpected Shutdown

  THE MANUFACTURER RECEIVED INFORMATION FROM A NURSE ALLEGING A PATIENT EXPERIENCED THAT THE POWER SUDDENLY TURNED OFF WHILE USING A TRILOGY EVO O2 DEVICE. THEY PRESSED THE POWER BUTTON AGAIN THEN THE SCREEN TURNED COMPLETELY RED, AND THE TRILOGY EVO O2 DEVICE BECAME INOPERABLE. THE NURSE REPLACED THE DEVICE WITH ANOTHER DEVICE. THERE WAS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS SPECIFIED BY THE PATIENT. THE TRILOGY EVO O2 DEVICE WAS RETURNED TO THE MANUFACTURER SERVICE CENTER FOR EVALUATION, AND THE CUSTOMER¿S COMPLAINT WAS CONFIRMED. DURING THE EVALUATION IT WAS NOTED THAT TWO ERROR CODES, DEVICE CALIBRATION DATA CRC FAILURE AND EVENT NVDATA CORRUPT, WERE OBSERVED ON THE DEVICE'S ERROR LOG. THE MANUFACTURER SERVICE TECHNICIAN FURTHER EVALUATED AND DETERMINED THE SYSTEM PRINTED CIRCUIT ASSEMBLY (PCA) HAD CAUSED THE ISSUE TO OCCUR ON THIS DEVICE. THE ROOT CAUSE IS CONFIRMED AT THIS TIME. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, THE DISPLAY PCA WAS REPLACED FOR AN UNSTABLE CONDITION THAT WAS OBSERVED, IN WHICH ALARM LOGS ARE NOT RECORDED AT THE OCCURRENCE OF ALARMS UNRELATED TO THE REPORTABLE ISSUE. THE SOFTWARE VERSION WAS UPGRADED TO 1

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25257947 ↗
• MalfunctionMay 15, 2026Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A TRILOGY EVO WAS ALARMING FOR A SERVICE REQUIRED ALARM CONDITION AND THE OXYGEN CONCENTRATION FAILED TO INCREASE WITH THE FIO2 SETTINGS. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S SERIVCE CENTER AND THE CUSTOMERS COMPLAINT WAS CONFIRMED. A SERVICE REQUIRED ALARM INDICATING THE O2 PROPORTIONAL IS EITHER STUCK OPEN OR CLOSED WAS OBSERVED IN THE DEVICE'S DOWNLOADED EVENT LOG. THE DEVICE'S OXYGEN BLENDING MODULE SUBASSEMBLY WAS 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 25185569 ↗
• MalfunctionMay 15, 2026Failure to Calibrate

  THE MANUFACTURER RECEIVED INFORMATION THAT A TRILOGY EVO, O2 WAS RETURNED TO THE MANUFACTURER'S SERVICE CENTER FOR COMPLETION OF PREVENTATIVE MAINTENANCE. THERE WAS NO PATIENT INVOLVEMENT, AND NO HARM OR INJURY REPORTED. PREVENTATIVE MAINTENANCE WAS COMPLETED ON THE DEVICE AS PER MAINTENANCE SCHEDULE. THE DEVICE FAILED DURING PRE-TEST FOR SYSTEM LEAK VERIFICATION: PRESSURE DROP OVER 10S. IT WAS REPORTED THE IN-LINE PROXIMAL FILTER WAS REPLACED TO ADDRESS THE ISSUE. THE DEVICE PASSED FINAL TESTING AND WAS CONFIRMED TO OPERATE PROPERLY. ADDITIONAL FINDINGS NOT RELATED TO THE MALFUNCTION/ISSUE: SINCE NOISE WAS CONFIRMED, THE BLOWER WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25183881 ↗
• MalfunctionMay 14, 2026Circuit Failure; Failure to Calibrate

  A TRILOGY EVO WAS RETURNED TO THE MANUFACTURER FOR PREVENTATIVE MAINTENANCE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE SYSTEM LEAK TEST FAILED. THE DEVICE'S OXYGEN BLENDING MODULE WAS REPLACED TO ADDRESS THE ISSUE A FINAL REPORT IS BEING SUBMITTED. IF NEW INFORMATION BECOMES AVAILABLE FOLLOWING FURTHER EVALUATION 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 25173245 ↗
• MalfunctionMay 7, 2026Circuit Failure; Device Sensing Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A TRILOGY EVO VENTILATOR EXPERIENCED A VENTILATOR SERVICE REQUIRED ALARM. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. DURING EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, A VENTILATOR SERVICE REQUIRED ERROR CODE RELATING TO 'PRESS SENSOR MISMATCH' WAS FOUND IN THE DEVICE'S ERROR LOG. THE SERVICE TECHNICIAN STATES THAT INTERNAL CHECKING WAS PERFORMED AND NO FAILURE WAS CONFIRMED. THE FUNCTIONAL TEST PASSED AS WELL. IT IS DETERMINED THAT A TEMPORARY FAILURE MAY HAVE OCCURRED AND THE SERVICE TECHNICIAN REPLACED THE FLOW SENSOR AND SYSTEM PRINTED CIRCUIT ASSEMBLY (PCA) BOARD TO RESOLVE THE ISSUE. THE BLOWER ASSEMBLY WAS REPLACED AS WELL DUE TO NOISE. FINAL TESTING, BATTERY CHECK, VALVE CHECK, RUN IN TESTING, AND CLEANING WERE PERFORMED. THE UNIT OPERATED PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25113456 ↗
• MalfunctionMay 1, 2026Battery Problem

  THE MANUFACTURER RECIEVED INFORMATION THAT A TRILOGY EVO DEVICE IS ALARMING "VENTILATOR SERVICE REQUIRED" BY A HOSPITAL MEDICAL ENGINEER. NO PATIENT HARM OR INJURY WAS REPORTED. UPON CHECKING THE ALARM/EVENT LOG, AN ERROR INDICATING A SUPER CAPACITOR ABNORMALITY OR AN ABNORMALITY OF THE CHARGING CIRCUIT FOR THE SUPER CAPACITOR WAS RECORDED AS THE RELEVANT ALARM, SO THE SYSTEM PCA (CIRCUIT BOARD) WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25055000 ↗
• MalfunctionApr 29, 2026Circuit Failure; Electrical /Electronic Property Problem

  A TRILOGY EVO O2 VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR PREVENTATIVE MAINTENANCE SERVICE. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. DURING EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, A VENTILATOR INOPERATIVE ERROR CODE RELATING TO 'PRESSURE SENSORS FAILURE' WAS FOUND IN THE DEVICE'S ERROR LOG. THE SERVICE TECHNICIAN STATES THAT THE SYSTEM PRINTED CIRCUIT ASSEMBLY (PCA) BOARD WAS REPLACED TO RESOLVE THE ISSUE. ADDITIONALLY, TWO NOT REPORTABLE ERROR CODES RELATING TO 'OUT PRESS RAILED HIGH' AND 'MON PRESS RAILED HIGH' WERE ALSO FOUND IN THE DEVICE'S ERROR LOG. THE SYSTEM PCA REPLACEMENT RESOLVE THESE ERRORS AS WELL. THE BLOWER ASSEMBLY WAS REPLACED DUE TO NOISE. THE VANITY COVER ASSEMBLY WAS REPLACED AS WELL. THE AIR INLET FOAM FILTER AND PARTICLE FILTER WERE REPLACED FOR MAINTENANCE. FINAL TESTING, BATTERY CHECK, VALVE CHECK, RUN IN TESTING, AND CLEANING WERE PERFORMED. THE UNIT OPERATED PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25034945 ↗
• MalfunctionApr 24, 2026Mechanical Problem; Failure to Calibrate

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THAT A TRILOGY EVO O2 JAPAN DEVICE FAILED THE ACTIVE EXHALATION VERIFICATION TEST DURING FINAL TESTING ASSOCIATED WITH FIELD CHANGE ORDER SERVICE. NO PATIENT HARM WAS REPORTED, AND THE DEVICE WAS NOT IN PATIENT USE AT THE TIME OF THE EVENT. DURING EVALUATION AT THE MANUFACTURER'S SERVICE CENTER, THE TECHNICIAN REPLACED THE DEVICE'S PROPORTIONAL VALVE (AECM) TO ADDRESS THE REPORTED ISSUE. THE TECHNICIAN THEN PERFORMED FINAL TEST, BATTERY CHECK, VALVE CHECK, RUN-IN TESTING, AND CLEANING. THE DEVICE WAS CONFIRMED TO OPERATE PROPERLY FOLLOWING THESE ACTIVITIES. 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 24984638 ↗
• MalfunctionApr 23, 2026Electrical /Electronic Property Problem; Battery Problem

  THE MANUFACTURER RECEIVED INFORMATION THAT THE TRILOGY EVO DEVICE HAD A VENTILATOR SERVICE REQUIRED ALARM. NO DEATH. NO SERIOUS HARM OR INJURY WAS REPORTED. THE DEVICE WAS RETURNED TO THE SERVICE CENTER. DURING THE EVALUATION, THE VENT SERVICE REQUIRED ALARM WAS CONFIRMED. THE SERVICE TECHNICIAN OBSERVED ERROR CODE E059 (EVT_BATTERY_NOT_CHARGING_FAULT) IN THE ERROR LOG, INDICATING A MALFUNCTION OCCURRED DURING CHARGING OF THE INTERNAL BATTERY. TO RESOLVE THE ISSUE, THE INTERNAL BATTERY WAS REPLACED. ADDITIONALLY, NOT RELATED TO THE REPORTABLE MALFUNCTION, THE BLOWER ASSEMBLY WAS REPLACED DUE TO NOISE, AND THE AIR INLET FOAM FILTER AND PARTICLE FILTER WERE REPLACED FOR PREVENTATIVE MAINTENANCE. THE FINAL TEST, BATTERY CHECK, VALVE CHECK, RUN IN TESTS, AND CLEANING WERE PERFORMED AND CONFIRMED THAT 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 24971752 ↗
• MalfunctionApr 23, 2026Mechanical Problem; Failure to Calibrate

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE ACTIVE EXHALATION VERIFICATION TEST STEP HAD FAILED DURING PREVENTATIVE MAINTENANCE ON A TRILOGY EVO O2 DEVICE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. THE TRILOGY EVO O2 DEVICE WAS BEING EVALUATED AT THE MANUFACTURER SERVICE CENTER WHEN THE ACTIVE EXHALATION VERIFICATION TEST STEP HAD FAILED ON THE DEVICE. DURING THE EVALUATION IT WAS NOTED THAT THERE WAS DAMAGE (OR PINCHED) TO THE ATM TUBE THAT IS LOCATED BETWEEN THE FLOW SENSOR AND FIO2 TUBING THAT HAD CAUSED THE ACTIVE EXHALATION VERIFICATION TEST STEP TO FAIL ON THE DEVICE. IN CONCLUSION, THE DEVICE'S ATM TUBE WAS REROUTED TO ADDRESS THE ISSUE. THE ROOT CAUSE IS CONFIRMED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24969967 ↗
• MalfunctionApr 21, 2026Mechanical Problem; Failure to Calibrate

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING ("OXYGEN REGULATION" ALARM AND "VENTILATOR SERVICE REQUIRED" ALARM OCCURRED WHEN THEY SWITCHED TO LOW PRESSURE OXYGEN) REGARDING A TRILOGY EVO, O2 VENTILATOR. THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE TRILOGY EVO, O2 VENTILATOR WAS RETURNED TO THE MANUFACTURER SERVICE CENTER FOR EVALUATION, AND THE CUSTOMER¿S COMPLAINT OF "OXYGEN REGULATION" ALARM OCCURRED WAS REPRODUCED. DURING THE EVALUATION ERROR CODES IN RELATION TO O2_PROP_STUCK AND OBM_VALVE_FAILURE WERE RECORDED IN THE DEVICE EVENT LOG. IT IS DETERMINED THAT THE ISSUE WAS CAUSED BY A MALFUNCTION OF THE PROPORTIONAL VALVE INSIDE OXYGEN BLENDER MODULE (OBM) SUB ASSEMBLY, THEREFORE THE OBM SUB ASSEMBLY WAS REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, PERIODIC MAINTENANCE 1 WAS PERFORMED AND THE AIR INLET FOAM FILTER AND PARTICLE FILTER WERE REPLACED. 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 24938301 ↗
• MalfunctionApr 20, 2026Electrical /Electronic Property Problem; Device Sensing Problem

  THE MANUFACTURER RECEIVED INFORMATION FROM THE MECHANICAL ENGINEER (ME) ALLEGING A PATIENT EXPERIENCED OXYGEN REGULATION ALARM HAD OCCURRED WHILE USING A TRILOGY EVO O2 DEVICE. THERE WAS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS SPECIFIED BY THE PATIENT. THE TRILOGY EVO O2 WAS RETURNED TO THE MANUFACTURER SERVICE CENTER FOR EVALUATION, AND THE CUSTOMER¿S COMPLAINT WAS NOT CONFIRMED. DURING THE EVALUATION IT WAS NOTED THAT AN ERROR CODE, OXYGEN BLENDING MODULE (OBM) VALVE FAILURE, WAS OBSERVED ON THE DEVICE'S ERROR LOG, RATHER THAN THE OXYGEN REGULATION ERROR CODE. THE SERVICE TECHNICIAN FURTHER EVALUATED AND DETERMINED A FLOW CONTROL ISSUE OCCURRED DUE TO A VALVE INSIDE THE OBM. IN CONCLUSION, THE DEVICE'S OBM SUBASSEMBLY WAS REPLACED TO ADDRESS THE ISSUE. THE ROOT CAUSE IS CONFIRMED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24926857 ↗
• MalfunctionApr 20, 2026Electrical /Electronic Property Problem; Battery Problem

  THE MANUFACTURER RECEIVED A REPORT THAT A TRILOGY EVO VENTILATOR WAS RETURNED FOR PREVENTIVE MAINTENANCE. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. DURING THE INVESTIGATION, THE DEVICE LOG FILES WERE SUCCESSFULLY DOWNLOADED AND REVIEWED IN FULL. ¿VENTILATOR SERVICE REQUIRED¿ ALARMS WERE TRIGGERED DUE TO A PERMANENT FAILURE OF THE INTERNAL LI-ION BATTERY. ADDITIONAL ERRORS WERE ASSOCIATED WITH CONDITIONS INCLUDING INTERNAL BATTERY CONNECTION ISSUES WITH V_WAKE_INT < 10.000V, POTENTIAL FAILURE OF THE V_WAKE_INT OR CHECK_WAKE_INT CIRCUITS, OR AN ANALOG-TO-DIGITAL CONVERTER (ADC) FAULT. TO ADDRESS THESE FINDINGS, THE INTERNAL BATTERY WAS REPLACED. SEPARATELY, AND NOT RELATED TO THE REPORTED MALFUNCTION, THE FLOW SENSOR WAS REPLACED AT THE CUSTOMER¿S REQUEST AS A PREVENTIVE MEASURE, ALTHOUGH NO CONTAMINATION OR DEBRIS WAS CONFIRMED. PREVENTIVE MAINTENANCE ACTIVITIES WERE ALSO COMPLETED IN ACCORDANCE WITH STANDARD SERVICE PROCEDURES, INCLUDING REPLACEMENT OF THE AIR INLET FOAM FILTER AND PARTICULATE FILTER. FOLLOWING REPAIRS, THE DEVICE UNDERWENT FINAL FUNCTIONAL TESTING, INCLUDING BATTERY VERIFICATION, VALV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24925158 ↗
• MalfunctionApr 16, 2026Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THAT A PATIENT USING A TRILOGY EVO O2 VENTILATOR EXPERIENCED A 'LOW INSPIRATORY PRESSURE' ALARM AND THAT AIRFLOW STOPPED DURING USE. ADDITIONALLY, IT IS BELIEVED THAT A 'CIRCUIT DISCONNECTED' ALARM DID NOT SOUND. THE PATIENT EXPERIENCED A DECREASE IN SPO2 AND CYANOSIS APPEARED. THE PATIENT WAS SWITCHED TO AN AMBU BAG AND THE PATIENT RECOVERED. THE CLINICAL ASSESSMENT TEAM INITIALLY EVALUATED THE COMPLAINT AS A NON-SERIOUS INJURY. THE COMPLAINT HAS SINCE BEEN REASSESSED AND THE CLINICAL ASSESSMENT TEAM STATES THAT 'THIS NOTIFICATION WAS REVIEWED DUE TO A REPORT OF A CALL STATING ON 11/22/2024 AT 13:33, THE PATIENT WAS GOING TO TAKE A BATH. THE PATIENT TAKES A BATH WITH THE DEVICE ON; SO, THEY MOVED TO THE BATHROOM AFTER REMOVING THE AC POWER. THE DEVICE WAS COVERED WITH A PLASTIC BAG TO PREVENT GETTING WET. AT 13:49 THE DEVICE WAS REMOVED FROM THE PATIENT TEMPORARILY, THEN WAS PUT ON THEM SOON. AT 15:54 A "LOW INSPIRATORY PRESSURE" ALARM WENT OFF, AND THE AIRFLOW STOPPED DURING USE ON THE PATIENT. AT 15:59 THE PATIENT HAD AN UNSPECIFIED DECREASE IN SPO2 AND CYANOSIS APPEARED. THE PATIENT WAS SWITCHED TO AMBU BAG AND THE PATIENT RECOVERE

  Patient problems: Cyanosis; Low Oxygen Saturation

  MAUDE report 24897311 ↗
• MalfunctionApr 15, 2026Computer Software Problem; Electrical /Electronic Property Problem; Battery Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A TRILOGY EVO O2 VENTILATOR SCREEN BLACKED OUT AND THE DEVICE TURNED OFF AFTER ATTEMPTING A SOFTWARE UPGRADE. AFTER THE DEVICE STARTED AGAIN, NO STARTUP SOUND WAS HEARD AND THE SCREEN DISPLAYED VERSION 1.06.10. THE DISPLAY REMAINED IN ENGLISH AND THE NUMERICAL VALUES WERE NOT DISPLAYED. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. DURING EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, A VENTILATOR INOPERATIVE ERROR CODE RELATING TO 'THERAPY HELD IN BM' WAS FOUND IN THE DEVICE'S ERROR LOG. THE SERVICE TECHNICIAN STATES THAT THE SOFTWARE REINSTALLATION WAS PERFORMED AND WAS SUCCESSFULLY COMPLETED TO RESOLVE THE ERROR. ADDITIONALLY, AN 'INTERNAL BATTERY FAILED' ERROR CODE WAS ALSO FOUND IN THE DEVICE'S ERROR LOG. THE SERVICE TECHNICIAN STATES THAT INTERNAL BATTERY WAS REPLACED TO RESOLVE THE ERROR. AN ADDITIONAL NOT-REPORTABLE ERROR CODE RELATING TO 'DETACHABLE BATTERY FAILED' WAS ALSO PRESENT IN THE ERROR LOG. THE DETACHABLE BATTERY WAS REPLACED TO RESOLVE THE ERROR. FINAL TESTING, BATTERY CHECK, VALVE CHECK, RUN IN TESTING, AND CLEANING WERE PERFORMED. THE UNIT OPERATED PROPERLY. THE SOFTWARE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24888511 ↗
• MalfunctionApr 15, 2026Circuit Failure

  THE MANUFACTURER RECEIVED INFORMATION THAT A TRILOGY EVO VENTILATOR WAS REPORTED TO HAVE A VENTILATOR SERVICE REQUIRED ALARM. THERE WAS NO PATIENT INVOLVEMENT, AND NO HARM OR INJURY REPORTED. ON DEVICE EVALUATION, A VENTILATOR SERVICE REQUIRED ALARM WAS CONFIRMED. DEVICE ERROR CODES E-81 AND E-150 WERE CONFIRMED IN THE DEVICE ERROR LOG INDICATING THE HE OXYGEN PROPORTIONAL VALVE THAT CONTROLS THE FLOW OF OXYGEN TO THE BLOWER INLET WAS MECHANICALLY STUCK CLOSED OR OPEN AND OXYGEN FLOW COMMUNICATION CEASED AND THE SENSOR IS REPORTING THE SAME VALUE. SINCE THESE LOGGED ERROR CODES REGARDING THE OXYGEN BLENDING MODULE (OBM) OCCURRED AT THE SAME TIME ACCORDING TO THE ERROR LOG, IT WAS SPECULATED THAT THERE WAS A COMMUNICATION ABNORMALITY BETWEEN THE MAIN UNIT AND OBM. THE SYSTEM PRINTED CIRCUIT BOARD ASSEMBLY (PCA) WAS REPLACED FOR THE ISSUE AND IT WAS CONFIRMED THAT THE ISSUE WAS IMPROVED. BASED ON THE ABOVE, IT IS BELIEVED THAT THE INFORMATION OF FROM THE OBM COULD NOT BE EXTRACTED DUE TO A SYSTEM PCA MALFUNCTION, RESULTING IN "VENTILATOR SERVICE REQUIRED" ALARM OCCURRING. AFTER REPAIR, THE DEVICE PASSED FINAL TESTING AND CONFIRMED TO BE OPERATING PROPERLY. THE SOFTWARE VERSION WAS UP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24885132 ↗