Trilogy EV300, USA DS2200X11BRecalls & reported problems

Summary

The FDA's MAUDE database contains 2,071 adverse event reports that list this exact device (DI 00606959052017), received between Sep 9, 2020 and Sep 30, 2026 — classified as 8 injuries, 2,063 malfunctions.

The most frequently reported specific device problem is “Failure to Calibrate” (876 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-0293-2025 · 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-2942-2024 · 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. 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-1651-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

5. Mar 1, 2023Class IOpen, Classified

   The accuracy of delivered oxygen may deviate below the required tolerance of 5% from setpoint when providing high concentration oxygen therapy. Additionally, if equipped, the internal FiO2 sensor may indicate a value higher than the device is actually delivering. This may lead to under delivery of oxygen.

   Z-1288-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 2,071 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Mechanical Problem

  The manufacturer received information alleging a failed test step occurred on a Trilogy EV300 ventilator. The device was not in use on a patient at the time of the occurrence.The Trilogy EV300 ventilator was evaluated by a third-party service center (General Biomedical Service Inc) and the customer¿s states the preventative maintenance is failing the AECM portion of the System Final test. The manufacturer Remote Service Engineer reviewed the service manual and suggested repair for the failed test. The customer is taking responsibility to correct/repair the device. The remote service engineer noted: The system does not meet the specification for the performed service and is not returned to use.The customer has been notified to contact Philips if the repair recommendations does not address the device issue at which point a new service order will be created. The Remote Service Engineer noted: No further information will be obtained as this concluded Philips remote support to the customer for this event.A Good Faith Effort attempt will be made to gather additional information from the customer regarding the repair of the device. If additional information becomes available, a supplement

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951015 ↗
• MalfunctionSep 24, 2026Electrical /Electronic Property Problem; Device Sensing Problem

  The manufacturer received a report from a customer that a Trilogy EV300 ventilator has a Ventilator Service Required error in the device event logs. The system is unavailable for patient/clinical use. NO patient harm or injury was reported.The device was evaluated by a Field Service Engineer (FSE). 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. To correct the issue, the machine flow sensor was replaced. Following completion of the service activities, the device passed all functional and performance testing.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50886298 ↗
• MalfunctionSep 24, 2026Failure to Calibrate

  The manufacturer received a report from a customer that a Trilogy EV300 ventilator failed the Active Exhalation Verification: S (+) P (+): Pilot: Reading test. No patient harm or injury was reported.The customer declined follow-up repair; therefore, no service documentation is available to identify the specific component(s) requiring replacement to address the issue.A final report is being submitted. If any additional information is received, a supplemental report will be filed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50885878 ↗
• MalfunctionSep 9, 2026Battery Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50695871 ↗
• MalfunctionJun 29, 2026Failure to Calibrate; Device Sensing Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE ACTIVE EXHALATION VERIFICATION TEST STEP HAD FAILED ON A TRILOGY EV300 DEVICE. THE DEVICE WAS NOT IN PATIENT USE. THE CUSTOMER WAS INFORMED THAT THE PROPORTIONAL VALVE AND THREE-WAY (3-WAY) SOLENOID VALVE WERE NEEDED TO PASS THE ACTIVE EXHALATION VERIFICATION TEST STEP FOR THIS DEVICE. THERE WERE NO REPAIRS AND/OR PARTS REPLACED BY PHILIPS. THE CUSTOMER IS TAKING RESPONSIBILITY TO MAKE THE NECESSARY REPAIRS TO THE TRILOGY EV300 DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25655369 ↗
• MalfunctionJun 24, 2026Mechanical Problem; Failure to Calibrate

  A TRILOGY EVO WAS RETURNED TO THE MANUFACTURER'S SERVICE CENTER FOR EVALUATION AFTER FAILING A TEST STEP. THERE WAS NO HARM OR INJURY REPORTED. THERE WAS NO EVIDENCE THE DEVICE WAS IN PATIENT USE. DURING THE EVALUATION THE DEVICE FAILED THE ACTIVE EXHALATION PURGE VALVE AND PROPORTIONAL VALVE TEST STEPS. THE DEVICE'S ACTIVE EXHALATION CONTROL MODULE AND 3 WAY VALVES NEEDS TO BE REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25616650 ↗
• MalfunctionJun 24, 2026Failure to Calibrate

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THAT A TRILOGY EV300 VENTILATOR FAILED THE ACTIVE EXHALATION TEST DURING PREVENTIVE MAINTENANCE SERVICE. THERE WAS NO ALLEGATION OF PATIENT HARM ASSOCIATED WITH THIS EVENT. THE DEVICE WAS NOT REPORTED TO BE IN PATIENT USE AT THE TIME THE ISSUE WAS IDENTIFIED. THE CUSTOMER REQUESTED A BENCH REPAIR OF THE DEVICE. EVALUATION OF THE TRILOGY EV300 VENTILATOR IS ANTICIPATED BUT HAS NOT YET BEGUN. THEREFORE, THE CAUSE OF THE REPORTED ISSUE HAS NOT BEEN DETERMINED. THE MANUFACTURER'S INVESTIGATION REMAINS ONGOING. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25614964 ↗
• MalfunctionJun 24, 2026Circuit Failure; Gas Output Problem; Mechanical Problem; Failure to Calibrate; Device Sensing Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A TRILOGY EVO FAILED TO DELIVER ACCURATE FIO2 PERCENTAGES. AT 21% THE DEVICE SHOWS 26% AND AT 100% THE DEVICE SHOWS 80%. THERE WAS NO HARM OR INJURY REPORTED. THERE WAS NO EVIDENCE THE DEVICE WAS IN PATIENT USE. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR BENCH REPAIR. DURING THE EVALUATION THE DEVICE FAILED A PNEUMATIC SETPOINT 80 TEST STEP AND AN ACTIVE EXHALATION PILOT DIFFERENCE TEST STEP AND FAILED FIO2 CALIBRATION. THE DEVICE'S MACHINE FLOW SENSOR, THREE-WAY SOLENOID VALVE AND FIO2 SENSOR NEED TO BE REPLACED TO ADDRESS THE ISSUES. ADDITIONALLY, SERVICE REQUIRED ALARM CONDITIONS INDICATING THE PROPORTIONAL VALVE IS STUCK OPEN/CLOSED AND AN O2 REGULATION ALARM INDICATING THE O2 CONCENTRATION WAS NOT WITHIN THE FIO2 SETPOINT WERE OBSERVED. THE DEVICE'S OXYGEN BLENDING MODULE AND SYSTEM BOARD NEED TO BE REPLACED TO ADDRESS THE ISSUES. A FINAL REPORT IS BEING SUBMITTED. IF NEW INFORMATION BECOMES AVAILABLE FOLLOWING THE COMPLETION OF THE DEVICE REPAIR THAT CHANGES THE OUTCOME OF THE INVESTIGATION AND ASSOCIATED MEDICAL DEVICE REPORTING A FOLLOW UP/SUPPLEMENTAL REPORT WILL BE COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25612446 ↗
• MalfunctionJun 24, 2026Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A FAILED TEST STEP OCCURRED ON A TRILOGY EV300 VENTILATOR. THE DEVICE WAS NOT REPORTED TO BE IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. THE TRILOGY EV300 VENTILATOR WAS EVALUATED BY A THIRD-PARTY SERVICE CENTER FIELD SERVICE ENGINEER, AND THE CUSTOMER¿S COMPLAINT WAS CONFIRMED. DURING THE EVALUATION IT WAS NOTED THAT THE DEVICE FAILED A PRE-TEST. IN CONCLUSION, THE DEVICE'S TRILOGY EVO 3 WAY SOLENOID VALVE AND PROPORTIONAL VALVE (AECM) NEEDS TO BE REPLACED TO ADDRESS THE ISSUE. THE REPAIRS HAVE NOT BEGUN, AND THE COMPLETION OF THE EVALUATION IS PENDING. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25609026 ↗
• MalfunctionJun 23, 2026Mechanical Problem; Failure to Calibrate

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THAT A TRILOGY EV300 DEVICE FAILED ACTIVE EXHALATION VERIFICATION. THE DEVICE WAS NOT REPORTED TO BE IN PATIENT USE, AND NO PATIENT HARM OR INJURY WAS ALLEGED. DURING THE EVALUATION OF THE TRILOGY EV300 DEVICE BY THE FIELD SERVICE ENGINEER (FSE) THE CUSTOMER'S COMPLAINT WAS CONFIRMED. INVESTIGATION DETERMINED THAT REPLACEMENT OF THE PROPORTIONAL VALVE (AECM) AND 3-WAY SOLENOID VALVE WAS REQUIRED TO ADDRESS THE CONDITION. THE COMPONENTS WERE REPLACED USING CUSTOMER-SUPPLIED REPLACEMENT PARTS AVAILABLE ON SITE. FOLLOWING THE REPAIR, THE DEVICE UNDERWENT A FULL PERFORMANCE VERIFICATION TEST (PVT) AND PASSED ALL TESTING, CONFIRMING THAT THE CORRECTIVE ACTIONS RESOLVED THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25598022 ↗
• MalfunctionJun 22, 2026Mechanical Problem; Calibration Problem

  A TRILOGY EV300 DEVICE FAILED THE PRESSURE VERIFICATION: SETPOINT 80: PILOT: DIFFERENCE DIAGNOSTIC TEST. A FIELD SERVICE ENGINEER (FSE) REPLACED THE SOLENOID AND AECM VALVES TO CORRECT THE TEST FAILURE. THE DEVICE PASSED TESTING. THE TRILOGY EVO PROPORTIONAL VALVE AND SOLENOID VALVE WERE RETURNED TO THE PRODUCT INVESTIGATION LAB (PIL) FOR ADDITIONAL TESTING. PIL WAS ABLE TO CONFIRM THE FAILURE OF THE TRILOGY EVO SOLENOID VALVE. VISUAL EXTERNAL INSPECTION FOUND NO DEFECTS. PIL PERFORMED POSTTEST ON THE PIL TRILOGY EVO MULTIFUNCTION TEST STATION, AND THE DEVICE FAILED. PIL CONCLUDES THAT THE COMPONENT DOES NOT OPERATE PROPERLY DUE TO SUSPECTED CONTAMINATION. PRODUCT INVESTIGATION LAB (PIL) IS UNABLE TO CONFIRM THE COMPLAINT OF THE TRILOGY EVO PROPORTIONAL VALVE. VISUAL INSPECTION FOUND NONE. PIL PERFORMED POSTTEST ON THE PIL TRILOGY EVO MULTIFUNCTION TEST STATION AND THE DEVICE PASSED TESTS. PIL CONCLUDES THE COMPONENT OPERATES PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25587964 ↗
• MalfunctionJun 22, 2026Failure to Calibrate

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A TRILOGY EVO FAILED AN ACTIVE EXHALATION VERIFICATION TEST STEP DURING TESTING. THERE WAS NO HARM OR INJURY REPORTED. THERE WAS NO EVIDENCE THE DEVICE WAS IN PATIENT USE. THE DEVICE EVALUATION HAS NOT YET BEEN COMPLETED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25579782 ↗
• MalfunctionJun 22, 2026Mechanical Problem; Failure to Calibrate

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A TRILOGY EV300, USA DEVICE WAS RETURNED TO A SERVICE CENTER FOR SERVICE OF A FIELD CHANGE ORDER. DURING THE EVALUATION OF THE TRILOGY EV300, USA DEVICE AT THE SERVICE CENTER, THE DEVICE FAILED THE ACTIVE EXHALATION VERIFICATION: S(+) P(+): PILOT: READING TEST AND BOTH THE PROPORTIONAL VALVE (AECM) AND 3 WAY SOLENOID VALVE NEED REPLACED TO ADDRESS THE TEST FAILURE. THE SERVICE TECHNICIAN HAS NOT COMPLETED THE REPAIR TO THE DEVICE YET. A FINAL REPORT IS BEING SUBMITTED. IF NEW INFORMATION BECOMES AVAILABLE FOLLOWING THE COMPLETION OF THE DEVICE REPAIR THAT CHANGES THE OUTCOME OF THE INVESTIGATION AND ASSOCIATED MEDICAL DEVICE REPORTING, A FOLLOW UP/SUPPLEMENTAL REPORT WILL BE COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25577891 ↗
• MalfunctionJun 22, 2026Failure to Calibrate

  THE MANUFACTURER RECEIVED A REPORT FROM A SERVICE ENGINEER, ON BEHALF OF THE CUSTOMER, THAT A TRILOGY EV300 VENTILATOR FAILED THE AECM PRETEST. NO PATIENT HARM OR INJURY WAS REPORTED. REVIEW OF THE TEST DOCUMENTATION SHOWED FAILURE OF THE ACTIVE EXHALATION VERIFICATION: S (+) P (+): PILOT: READING TEST. 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 25577413 ↗
• MalfunctionJun 18, 2026Failure to Calibrate

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A TRILOGY EVO FAILED AN ACTIVE EXHALATION CONTROL MODULE TEST STEP. THERE WAS NO HARM OR INJURY REPORTED. THERE WAS NO EVIDENCE THE DEVICE WAS IN PATIENT USE. THE DEVICE WAS NOT EVALUATED BY THE MANUFACTURER DUE TO THE CUSTOMER REFUSING THE REPAIR. THERE IS NO VERIFICATION OR RESOLUTION TO THE ALLEGED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25548573 ↗
• MalfunctionJun 18, 2026Failure to Calibrate

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE ACTIVE EXHALATION VERIFICATION TEST STEP HAD FAILED ON A TRILOGY EV300 DEVICE. THE DEVICE WAS NOT IN PATIENT USE. THE CUSTOMER STATED THAT THEY HAD CHANGED TO ANOTHER FLOW SENSOR, BUT THE ACTIVE EXHALATION VERIFICATION TEST STEP STILL FAILED ON THE DEVICE. THE CUSTOMER HAD DECIDED NOT TO PROCEED WITH THE REPAIR FOR THIS ISSUE, SO PHILIPS WAS NOT ABLE TO DETERMINE THE CAUSE OF THE ISSUE FOR THIS DEVICE. THE ROOT CAUSE IS NOT 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 25548563 ↗
• MalfunctionJun 18, 2026Circuit Failure

  THE MANUFACTURER RECEIVED INFORMATION THAT THE TRILOGY EV300 VENTILATOR FAILED TO HAVE A SOFTWARE UPDATE SUCCESSFULLY INSTALLED DURING SERVICE. THERE WAS NO PATIENT INVOLVEMENT, AND NO HARM OR INJURY REPORTED. ON DEVICE EVALUATION, VENTILATOR INOPERATIVE ERROR CODE E-156 WAS NOTED IN THE ERROR LOG INDICATING THE THERAPY CENTRAL PROCESSING UNIT (CPU) WAS STILL RUNNING IN BOOT MONITOR SOFTWARE. THE SYSTEM PRINTED CIRCUIT BOARD ASSEMBLY REQUIRED REPLACEMENT TO ADDRESS THIS ISSUE. ADDITIONAL FINDINGS NOT RELATED TO THE MALFUNCTION/ISSUE: INFORMATION RECEIVED THAT AFTER A REPAIR/SERVICE SOFTWARE UPGRADE WAS ATTEMPTED ON A TRILOGY EVO THE DEVICE BECAME INOPERATIVE. THIS INFORMATION DOES NOT INDICATE A MALFUNCTION OF THE DEVICE, YET A RESULT OF THE SERVICE BEING PROVIDED. IT HAS BEEN CONCLUDED THAT THE TRIGGER FOR THIS CONDITION WOULD NOT OCCUR DURING NORMAL OPERATION AND USE ON A PATIENT; THEREFORE, POSING NO ADDITIONAL SAFETY RISK FOR A PATIENT. BASED ON THE AVAILABLE INFORMATION, THERE IS NOT ENOUGH EVIDENCE TO SUGGEST IF THIS REPORTED ISSUE WERE TO RECUR THAT IT WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY. ON PHYSICAL INSPECTION, THE INTERNAL BATTERY WAS MISSING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25546713 ↗
• MalfunctionJun 18, 2026Mechanical Problem; Calibration Problem

  A TRILOGY EV300 DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. DURING THE EVALUATION, THE DEVICE FAILED THE ACTIVE EXHALATION VERIFICATION TEST (AECM PRETEST DURING FIELD CHANGE ORDER REMEDIATION WORK (B)(4)). THE SERVICE TECHNICIAN WILL NEED TO REPLACE THE DEFECTIVE PROPORTIONAL VALVE (AECM) AND 3-WAY SOLENOID VALVE TO CORRECT THE ISSUE. A FINAL REPORT IS BEING SUBMITTED. IF NEW INFORMATION BECOMES AVAILABLE FOLLOWING THE COMPLETION OF THE DEVICE REPAIR THAT CHANGES THE OUTCOME OF THE INVESTIGATION AND ASSOCIATED MEDICAL DEVICE REPORTING A FOLLOW UP/SUPPLEMENTAL REPORT WILL BE COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25546536 ↗
• MalfunctionJun 17, 2026Mechanical Problem; Failure to Calibrate

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THAT A TRILOGY EV300 DEVICE FAILED PREVENTIVE MAINTENANCE (PM) SERVICE AND FINAL TESTING. THE CUSTOMER INITIALLY SUSPECTED THAT THE ISSUE WAS RELATED TO THE OXYGEN BLENDER MODULE (OBM); HOWEVER, NO DOCUMENTATION OF A FAILED TEST OR CRITICAL ERROR WAS PROVIDED. THE CUSTOMER REPORTED THAT INSTALLATION OF A SPARE MODULE AVAILABLE AT THE SITE RESOLVED THE INITIAL ISSUE. THE DEVICE WAS SUBSEQUENTLY REPORTED TO BE FAILING PILOT SENSOR READINGS. THE DEVICE WAS NOT REPORTED TO BE IN PATIENT USE, AND NO PATIENT HARM OR INJURY WAS ALLEGED. DURING DIAGNOSTIC TESTING, BY A THIRD-PARTY SERVICE PROVIDER THE REPORTED ISSUE WAS REPLICATED. INVESTIGATION DETERMINED THAT REPLACEMENT OF THE 3-WAY SOLENOID VALVE AND PROPORTIONAL VALVE (AECM) WAS REQUIRED TO ADDRESS THE CONDITION. A WORK ORDER WAS ISSUED FOR REPLACEMENT MATERIALS, AND THE CUSTOMER WILL PERFORM THE REPAIR. BASED ON THE AVAILABLE INFORMATION, THE REPORTED CONDITION WAS ASSOCIATED WITH THE 3-WAY SOLENOID VALVE AND PROPORTIONAL VALVE (AECM). NO PATIENT HARM OR INJURY WAS REPORTED. A FINAL REPORT IS BEING SUBMITTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE FOLLOWING COMPLETION OF THE REPAIR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25540868 ↗
• MalfunctionJun 17, 2026Mechanical Problem; Failure to Calibrate

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THAT A TRILOGY EV300 DEVICE FAILED ACTIVE EXHALATION VERIFICATION. THE DEVICE WAS NOT REPORTED TO BE IN PATIENT USE, AND NO PATIENT HARM OR INJURY WAS ALLEGED. DURING THE EVALUATION OF THE TRILOGY EV300 DEVICE BY THE FIELD SERVICE ENGINEER (FSE) THE CUSTOMER'S COMPLAINT WAS CONFIRMED. INVESTIGATION DETERMINED THAT REPLACEMENT OF THE PROPORTIONAL VALVE (AECM) AND 3-WAY SOLENOID VALVE WAS REQUIRED TO ADDRESS THE CONDITION. THE COMPONENTS WERE REPLACED USING CUSTOMER-SUPPLIED REPLACEMENT PARTS AVAILABLE ON SITE. FOLLOWING THE REPAIR, THE DEVICE UNDERWENT A FULL PERFORMANCE VERIFICATION TEST (PVT) AND PASSED ALL TESTING, CONFIRMING THAT THE CORRECTIVE ACTIONS RESOLVED THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25540855 ↗
• MalfunctionJun 17, 2026Failure to Calibrate

  THE MANUFACTURER RECEIVED A REPORT FROM A SERVICE ENGINEER ON BEHALF OF THE CUSTOMER THAT A TRILOGY EV300 VENTILATOR FAILED A PRELIMINARY SYSTEM TEST ACTIVE EXHALATION VERIFICATION TEST. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. REVIEW OF THE TEST DOCUMENTATION CONFIRMED FAILURE OF AN ACTIVE EXHALATION VERIFICATION: S (+) P (+): READING TEST. THE CUSTOMER DECLINED FOLLOW-UP REPAIR; THEREFORE, NO SERVICE DOCUMENTATION IS AVAILABLE TO IDENTIFY THE SPECIFIC COMPONENT(S) REQUIRING REPLACEMENT TO ADDRESS THE ISSUE. A FINAL REPORT IS BEING SUBMITTED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25537870 ↗
• MalfunctionJun 17, 2026Failure to Calibrate

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A TRILOGY EVO FAILED AN ACTIVE EXHALATION CONTROL MODULE PRE-TEST TEST STEP DURING TESTING. THERE WAS NO HARM OR INJURY REPORTED. THERE WAS NO EVIDENCE THE DEVICE WAS IN PATIENT USE. THE DEVICE EVALUATION HAS NOT YET BEEN COMPLETED. 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 25535944 ↗
• MalfunctionJun 16, 2026Failure to Calibrate

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE ACTIVE EXHALATION VERIFICATION PILOT TEST STEP HAD FAILED ON A TRILOGY EV300 DEVICE. THE DEVICE WAS NOT IN PATIENT USE. THE SERVICE TECHNICIAN FURTHER EVALUATED AND DETERMINED THE MACHINE FLOW SENSOR HAD CAUSED THE VENTILATOR INOPERATIVE ALARM TO OCCUR ON THE DEVICE. IN CONCLUSION, THE DEVICE'S MACHINE FLOW SENSOR NEEDS REPLACED TO ADDRESS THE ISSUE. THE ROOT CAUSE IS CONFIRMED AT THIS TIME. THE CUSTOMER HAD DECIDED NOT TO PROCEED WITH THE REPAIR FOR THIS ISSUE SO PHILIPS WAS NOT ABLE TO DETERMINE THE CAUSE OF THE ISSUE FOR THIS DEVICE. THE ROOT CAUSE IS NOT 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 25522933 ↗
• MalfunctionJun 15, 2026Failure to Calibrate; Device Sensing Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE ACTIVE EXHALATION PILOT VERIFICATION TEST STEP HAD FAILED ON A TRILOGY EV300 DEVICE. THE DEVICE WAS NOT IN PATIENT USE. THE TRILOGY EV300 DEVICE WAS EVALUATED BY A PHILIPS SERVICE ENGINEER (SE). THE DEVICE EVALUATION FOUND PROPORTIONAL VALVE AND THREE-WAY (3-WAY) SOLENOID VALVE HAD CAUSED THE ACTIVE EXHALATION PILOT VERIFICATION TEST STEP TO FAIL ON THE DEVICE. THE CUSTOMER NEEDS TO REPLACE THE DEVICE'S PROPORTIONAL VALVE AND 3-WAY SOLENOID VALVE TO ADDRESS THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25508983 ↗
• MalfunctionJun 12, 2026Circuit Failure; Battery Problem; Power Problem

  THE MANUFACTURER RECEIVED INFORMATION THAT A TRILOGY EV300 VENTILATOR WAS RETURNED TO BENCH REPAIR FOR COMPLETION OF PREVENTIVE MAINTENANCE. THERE WAS NO PATIENT INVOLVEMENT, AND NO HARM OR INJURY REPORTED. ON EVALUATION, THE DEVICE PASSED ALL DIAGNOSTIC TESTING. DEVICE ERROR CODES WERE NOTED IN THE ERROR LOG INDICATING BOTH SOFT AND HARD POWER FAILURE AS WELL AS POWER VBUS DROPPED. THE INTERNAL BATTERY, POWER SUPPLY AND SYSTEM PRINTED CIRCUIT BOARD ASSEMBLY REQUIRED REPLACEMENT TO ADDRESS THESE ISSUES. ADDITIONAL FINDINGS NOT RELATED TO THE MALFUNCTION/ISSUE: THE IN-LINE PROXIMAL FILTER WAS CONTAMINATED, THE FLOW SENSOR WAS CONTAMINATED, AND THE OUTLET PANEL WAS CRACKED REQUIRING REPLACEMENT. PREVENTATIVE MAINTENANCE WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25494489 ↗