Trilogy Trilogy 200 Ventilator, U.S.A.-RecertRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00606959026230), received between Oct 28, 2015 and Jan 28, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Failure to Recalibrate” (6 reports).

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.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 28, 2026Failure to Calibrate

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE DEVICE FAILED THE POSITIVE FLOW VERIFY TEST STEP DURING TESTING. THE DEVICE WAS RECALIBRATED TO ADDRESS THE ISSUE. ADDITIONALLY, UNRELATED TO THE TEST FAIL, THE DEVICE WAS FOUND TO HAVE FEET MISSING. FEET INSTALLED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24202243 ↗
• MalfunctionDec 30, 2025Mechanical Problem; Failure to Recalibrate; Mechanical Problem; Failure to Recalibrate

  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, THE DEVICE FAILED TEST STEPS FOR TESTING FOR LOW OXYGEN FLOW, 240 VAC POWER SOURCE AVERAGE POWER AND POSITIVE FLOW VERIFY. THE DEVICE'S INLET AIR PATH, AIR PATH FOAM, AND FLOW PATH WERE REPLACED, AND THE DEVICE HAS BEEN RECALIBRATED TO ADDRESS THE ISSUES. THE DEVICE PASSED ALL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23921392 ↗
• MalfunctionDec 30, 2025Circuit Failure; Mechanical Problem; Failure to Recalibrate; Circuit Failure; Mechanical Problem; Failure to Recalibrate

  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, THE DEVICE FAILED TEST STEPS FOR LOW OXYGEN FLOW AND DP PURGE VALVES. THE DEVICE'S INLET AIR PATH, AIR PATH FOAM, SENSOR BOARD AND FLOW PATH WERE REPLACED TO ADDRESS THE ISSUES. THE DEVICE PASSED ALL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23921387 ↗
• MalfunctionNov 13, 2025Circuit Failure; Electrical /Electronic Property Problem; Circuit Failure; Electrical /Electronic Property Problem

  THE TRILOGY 200 VENTILATOR WAS RETURNED TO THE MANUFACTURER SERVICE CENTER FOR PREVENTATIVE MAINTENANCE, AND THE DEVICE FAILED A DP PURGE VALVE TEST STEP DURING TESTING. IN CONCLUSION, THE DEVICE'S SENSOR BOARD WAS REPLACED TO ADDRESS THE ISSUE. THE ROOT CAUSE IS CONFIRMED AT THIS TIME. THE DEVICE PASSED ALL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23543019 ↗
• MalfunctionOct 28, 2025Failure to Recalibrate; Failure to Recalibrate

  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, THE DEVICE FAILED A TEST STEP DURING TESTING FOR LOW OXYGEN FLOW. THE SERVICE TECHNICIAN DETERMINED ADJUSTMENT OF GREY REMOVABLE FOAM IS NECESSARY. THE FOAM WAS ADJUSTED CORRECTLY. THE DEVICE PASSED ALL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23408265 ↗
• MalfunctionOct 20, 2025Failure to Calibrate; Failure to Calibrate

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE LOW OXYGEN (O2) FLOW TEST STEP HAD FAILED ON A TRILOGY 200 DEVICE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. THE TRILOGY 200 DEVICE WAS EVALUATED AT THE MANUFACTURER. DURING THE EVALUATION IT WAS NOTED THAT THE GREY REMOVABLE FOAM WAS NOT PROPERLY ALIGNED CAUSING THE LOW O2 FLOW TEST STEP TO FAIL ON THE DEVICE. IN CONCLUSION, THE DEVICE'S GREY REMOVABLE FOAM WAS RE-ADJUSTED TO ADDRESS THE ISSUE. THE ROOT CAUSE IS CONFIRMED AT THIS TIME. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, THE BLOWER ASSEMBLY, OVERHEAD BLOWER FILTER, AND INLET FILTER WERE REPLACED WHICH WAS UNRELATED TO THE REPORTABLE ISSUE. THE OUTER ENCLOSURE CASE WAS CLEANED. THE DEVICE WAS RETESTED, AND IT PASSED ALL FINAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23341939 ↗
• MalfunctionOct 16, 2025Failure to Recalibrate; Failure to Recalibrate

  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, THE DEVICE FAILED A TEST STEP DURING TESTING FOR LOW OXYGEN FLOW. THE DEVICE'S INLET AIR PATH, AIR PATH FOAM, AND FLOW PATH WERE REPLACED TO ADDRESS THE ISSUE. THE DEVICE PASSED ALL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23319385 ↗
• MalfunctionSep 4, 2024Mechanical Problem; Failure to Recalibrate; Mechanical Problem; Failure to Recalibrate

  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, THE DEVICE FAILED A O2 LOW FLOW TEST STEP DURING TESTING. THE DEVICE'S ACTIVE EXHALATION CONTROL MODULE NEEDS TO BE REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20135939 ↗
• MalfunctionJan 25, 2024Failure to Recalibrate; Failure to Recalibrate

  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, THE DEVICE FAILED A TEST STEP DURING TESTING. THE DEVICE'S SENSOR BOARD WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18581542 ↗
• MalfunctionJan 10, 2024Battery Problem; Battery Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A BATTERY PACK ERROR WHICH WAS FOUND IN THE DOWNLOAD ERROR LOGS FOR THIS 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 18489431 ↗
• MalfunctionFeb 28, 2018Device Operational Issue; Device Operational Issue

  A VENTILATOR WAS RETURNED TO A THIRD PARTY SERVICE CENTER FOR EVALUATION. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT A THIRD PARTY SERVICE CENTER, A SERVICE REQUIRED ALARM CONDITION OCCURRED RELATED TO THE FAILURE OF THE DEVICE TO CHARGE ITS INTERNAL BATTERY. THE DEVICE'S INTERNAL BATTERY WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7302460 ↗
• MalfunctionDec 26, 2017Device Operational Issue; Device Operational Issue

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR ROUTINE PREVENTIVE MAINTENANCE. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. THE DEVICE WAS NOT IN PATIENT USE. 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 INTERNAL BATTERY NEEDS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 7146315 ↗
• MalfunctionJan 4, 2017Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR ROUTINE PREVENTIVE MAINTENANCE. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE DEVICE FAILED A STEP DURING TESTING. THE DEVICE'S ACTIVE EXHALATION CONTROL MODULE WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6221549 ↗
• MalfunctionOct 28, 2015Device Inoperable; Device Displays Incorrect Message

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. THE VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND THE CUSTOMER'S COMPLAINT WAS CONFIRMED. THE DEVICE'S BLOWER MOTOR AND SYSTEM BOARD WERE REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5183469 ↗