Trilogy EV300 FX2200X15BRecalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00606959061033), received between Feb 24, 2021 and Sep 28, 2026 — classified as 34 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (10 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 16, 2026.

Recalls naming this device

1. Oct 7, 2024Open, 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, 2024Open, 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, 2024Open, 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, 2023Open, 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, 2023Open, 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 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Circuit Failure; Electrical /Electronic Property Problem

  The manufacturer received a report from a customer that a Ventilator Inoperative alarm occurred on a Trilogy EV300 ventilator. No patient harm or injury was reported.The ventilator was evaluated by a Field Service Engineer (FSE). The System Board was suspected to be defective. Once the System Board was replaced and the software was reloaded, the ventilator was operating properly.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50912946 ↗
• MalfunctionJun 10, 2026Circuit Failure; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING VENTILATOR SERVICE REQUIRED ERROR CODES WERE OBSERVED ON A TRILOGY EV300 DEVICE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. THE DEVICE WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER. DURING EVALUATION, IT WAS NOTED THAT ERROR CODES, OXYGEN BLENDING MODULE VALVE FAILURE, OXYGEN PROPORTIONAL STUCK, AND OXYGEN FLOW STUCK, WERE OBSERVED ON THE DEVICE'S ERROR LOG. THE THIRD-PARTY SERVICE TECHNICIAN REPLACED THE SYSTEM PCA TO RESOLVE THE REPORTABLE ERROR CODES. UNRELATED TO THE REPORTABLE MALFUNCTION, SYSTEM PCA REPLACEMENT RESOLVED ADDITIONAL ERROR CODES PERTAINING TO FIO2 SENSOR RAILED LOW AND FAN FAILURES THAT WERE DISCOVERED IN THE LOG. ADDITIONALLY, THE SOFTWARE WAS UPGRADED. THE FOAM AND PARTICULATE FILTERS WERE REPLACED AS PER THE SERVICE MANUAL SERVICE SCHEDULE. THE DEVICE PASSED PERFORMANCE VERIFICATION. THE SYSTEM PCA WAS THEN FORWARDED TO THE PHILIPS INVESTIGATION LAB (PIL) FOR FURTHER EVALUATION. PIL RETRIEVED AND REVIEWED THE ERROR LOG FROM THE SYSTEM PCA. AN ADDITIONAL REPORTABLE ERROR CODE PERTAINING TO SUPERCAP FAILURE WAS DISCOVERED IN THE LOG. PIL INSTALLED THE SYSTEM PCA ON THE TRILOGY EVO STB, W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25461391 ↗
• MalfunctionMar 31, 2026Circuit Failure; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION 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 INITIALLY EVALUATED REMOTELY BY A PHILIPS SERVICE TECHNICIAN, AND THE CUSTOMERS COMPLAINT WAS CONFIRMED. AN ONSITE FOLLOW UP WAS REQUIRED BY A THIRD-PARTY SERVICE CENTER FIELD SERVICE ENGINEER, AND THE OCCURRENCE WAS CONFIRMED DURING THE EVALUATION. IN CONCLUSION, THE DEVICE'S SYSTEM BOARD AND FLOW SENSOR WERE REPLACED TO ADDRESS THE ISSUE. THE DEVICE PASSED ALL TEST, AND THE SYSTEM MEETS THE SPECIFICATION FOR THE PERFORMED SERVICE AND IS RETURNED TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24740514 ↗
• MalfunctionMar 30, 2026Mechanical Problem

  THE MANUFACTURER RECEIVED INFORMATION THAT A LOANED TRILOGY EV300 VENTILATOR HAD A "VENTILATOR SERVICE REQUIRED" ERROR ON THE SCREEN. THERE WAS NO PATIENT INVOLVEMENT, AND NO HARM OR INJURY REPORTED. A PHILIPS FIELD SERVICE ENGINEER EVALUATED THE DEVICE AT THE CUSTOMER'S SITE. A REVIEW OF THE VENTILATOR SERVICE REQUIRED ALARM INDICATED FAILURE OF THE OXYGEN BLENDING MODULE. THE OXYGEN BLENDING MODULE ASSEMBLY WAS REPLACED AND THE DEVICE RE-TESTED. THE DEVICE DID NOT HAVE ANY ERROR OCCUR AFTER THE REPAIR. THE DEVICE WAS HANDED BACK TO THE CUSTOMER IN GOOD WORKING CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24715963 ↗
• MalfunctionJan 9, 2026Mechanical Problem; Failure to Calibrate

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR FAILED AN ACTIVE EXHALATION VERIFICATION TEST STEP FAILURE DURING TESTING. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS NOT IN PATIENT USE. THE MANUFACTURER'S FIELD SERVICE ENGINEER EVALUATED THE DEVICE ONSITE AND STATES THE DEVICE'S THREE-WAY SOLENOID VALVE AND PROPORTIONAL VALVE NEED TO BE REPLACED TO ADDRESS THE ISSUE. THE DEVICE IS TO RETURN FOR BENCH REPAIR. 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 24019021 ↗
• MalfunctionDec 16, 2025Failure to Calibrate; Failure to Calibrate

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR 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 MANUFACTURER'S FIELD SERVICE ENGINEER EVALUATED THE DEVICE ONSITE AND STATES THE DEVICE'S THREE-WAY SOLENOID VALVE NEEDS TO BE REPLACED TO ADDRESS THE ISSUE. THE DEVICE IS TO RETURN FOR BENCH REPAIR. 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 23816427 ↗
• MalfunctionDec 10, 2025Gas/Air Leak; Gas/Air Leak

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR 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 EVALUATED BY THE MANUFACTURER'S FIELD SERVICE TECHNICIAN. A LEAK WAS FOUND IN THE DEVICE'S OXYGEN BLENDING MODULE SUBASSEMBLY. THE DEVICE'S OXYGEN BLENDING MODULE SUBASSEMBLY WAS REPLACED. THE DEVICE RETURNED TO THE CUSTOMER IN WORKING ORDER. THERE WAS NO DOWNLOADED EVENT LOG AVAILABLE AT THIS TIME FOR REVIEW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23767673 ↗
• MalfunctionDec 10, 2025No Visual Prompts/Feedback; No Visual Prompts/Feedback

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR'S TOUCHSCREEN WAS NOT RESPONDING. THERE WAS NO HARM OR INJURY REPORTED. THERE WAS NO EVIDENCE THE DEVICE WAS IN PATIENT USE. THE DEVICE WAS EVALUATED BY THE MANUFACTURER'S FIELD SERVICE ENGINEER AND THE CUSTOMER'S COMPLAINT WAS CONFIRMED. THE DEVICE'S DISPLAY WAS REPLACED TO ADDRESS THE ISSUE. THE DEVICE WAS RETURNED TO WORKING ORDER AFTER THE REPAIRS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23767565 ↗
• MalfunctionAug 2, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. AT THIS TIME, THE MANUFACTURER IS UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22694011 ↗
• MalfunctionJul 25, 2025Mechanical Problem; Failure to Calibrate; Mechanical Problem; Failure to Calibrate

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE FOR THE ALLEGATION "PIP AND PRESSURE GRAPH NOT COMING". THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS NOT REPORTED TO BE IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE DEVICE FAILED THE SYSTEM SETUP TEST DURING TESTING. THE TECHNICIAN RECOMMENDED REPLACING THE DEVICE'S ACTIVE EXHALATION CONTROL MODULE TO ADDRESS THE ISSUE. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. THE DEVICE PASSED FINAL TESTING. 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 22610189 ↗
• MalfunctionMay 19, 2025No Display/Image; Mechanical Problem; No Display/Image; Mechanical Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR'S DISPLAY SCREEN WAS UNABLE TO BE VIEWED. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE HAS NOT YET BEEN EVALUATED. THE CUSTOMER WAS REQUESTING A QUOTE BEFORE HAVING THE DEVICE REPAIRED. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22044037 ↗
• MalfunctionMay 12, 2025Pressure Problem; Pressure Problem

  THE TRILOGY EV300 VENTILATOR WAS SENT TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION. THE DEVICE WAS NOT IN PATIENT USE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, A TECHNICIAN CONFIRMED " PIP PRESSURE WAS NOT COMING OUT". THE DEVICE'S SYSTEM BOARD WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22001476 ↗
• MalfunctionMay 12, 2025Pressure Problem; Pressure Problem

  THE TRILOGY EV300 VENTILATOR WAS SENT TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION. THE DEVICE WAS NOT IN PATIENT USE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, A TECHNICIAN CONFIRMED " PIP PRESSURE WAS NOT COMING OUT". THE DEVICE'S SYSTEM BOARD WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22001344 ↗
• MalfunctionApr 2, 2025Output Problem; Output Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING PIP AND PRESSURE GRAPH NOT COMING. THERE WAS NO HARM OR INJURY REPORTED. MATERIAL ONLY WORKORDER CREATED FOR SHIPMENT OF REPLACEMENT SYSTEM BOARD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21752785 ↗
• MalfunctionFeb 3, 2025No Display/Image; No Display/Image

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR'S PRESSURE WAVEFORM AND VALUES WERE NOT DISPLAYING ON THE LCD SCREEN. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE EVALUATION HAS YET TO BE COMPLETED. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21291647 ↗
• MalfunctionSep 6, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20164071 ↗
• MalfunctionMar 19, 2024No Display/Image; No Display/Image

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A DEVICE SCREEN IS CRACKED; THE BACKLIGHT COMES ON, BUT SCREEN DOES NOT ON A TRILOGY EV300 DEVICE. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18937492 ↗
• MalfunctionOct 10, 2023Circuit Failure; Mechanical Problem; Circuit Failure; Mechanical Problem

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THE VENTILATOR WAS DUE A SERVICE, BUT WHEN IT WAS IN CLINICAL USE THE END USERS WERE GETTING ALARMS.THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, A "SERVICE REQUIRED" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S 3-WAY SOLENOID VALVE & SYSTEM BOARD, AND FIO2 SENSOR WERE REPLACED TO RESOLVE TEST FAILURE. THE DEVICE PASSED PERFORMANCE VERIFICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17907241 ↗
• MalfunctionSep 29, 2023Failure to Recalibrate; Failure to Recalibrate

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR FAILED A TEST STEP. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17844788 ↗
• MalfunctionSep 29, 2023Failure to Recalibrate; Failure to Recalibrate

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR FAILED THE ACTIVE EXHALATION VERIFICATION TEST. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17844382 ↗
• MalfunctionSep 29, 2023Failure to Recalibrate; Failure to Recalibrate

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR FAILED A TEST STEP DURING TESTING. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17843263 ↗
• MalfunctionSep 11, 2023Failure to Recalibrate; Failure to Recalibrate

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR 02 SENSOR FAIL TO CALIBRATE. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17719669 ↗
• MalfunctionJun 16, 2023Circuit Failure; Mechanical Problem; Circuit Failure; Mechanical Problem

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, A "SERVICE REQUIRED" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S OXYGEN BLENDING MODULE BOARD AND SYSTEM BOARD NEED REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17148104 ↗
• MalfunctionFeb 24, 2023Circuit Failure; Mechanical Problem; Circuit Failure; Mechanical Problem

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, A "SERVICE REQUIRED" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S BLOWER ASSEMBLY AND SYSTEM BOARD WERE REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16438523 ↗
• MalfunctionFeb 14, 2023Circuit Failure; Circuit Failure

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, A "VENTILATOR INOPERATIVE" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S SYSTEM BOARD WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16372284 ↗