Trilogy 200 Trilogy 200 Ventilator, Bluetooth, CanadaRecalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00606959026452), received between Mar 22, 2017 and May 11, 2026 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Failure to Calibrate” (8 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 11, 2026Failure to Calibrate; Infusion or Flow Problem

  A TRILOGY 200 VENTILATOR WAS RETURNED TO THE MANUFACTURER'S SERVICE CENTER FOR SERVICE. NO PATIENT HARM OR INJURY WAS REPORTED. THE DEVICE WAS NOT IN CLINICAL USE. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE TRILOGY 200 VENTILATOR FAILED TESTING FOR "CHECK LEAK: CONTROL FLOW". THE SENSOR BOARD WILL NEED TO BE REPLACED TO ADDRESS THE FAILED TEST. THE REPAIR IS AWAITING CUSTOMER APPROVAL AT THIS TIME. 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 25135089 ↗
• MalfunctionApr 3, 2026Failure to Calibrate

  THE MANUFACTURER RECEIVED A REPORT THAT A TRILOGY 200 VENTILATOR WAS RETURNED FOR SERVICE. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY ASSOCIATED WITH THIS EVENT. THE DEVICE WAS EVALUATED AT A THIRD-PARTY SERVICE CENTER. VISUAL INSPECTION IDENTIFIED THAT THE POWER CORD CLAMP WAS MISSING AND THE UNIVERSAL PORTING BLOCK WAS CRACKED. DURING FUNCTIONAL TESTING, THE DEVICE FAILED THE DIFFERENTIAL PRESSURE (DP) CALIBRATION TEST. AVAILABLE SERVICE DOCUMENTATION DID NOT INDICATE THAT REPLACEMENT OF ANY COMPONENTS WAS REQUIRED TO ADDRESS THIS ISSUE. FOLLOWING REPAIR, THE DEVICE SUCCESSFULLY PASSED ALL REQUIRED FUNCTIONAL AND PERFORMANCE TESTING. 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 24775089 ↗
• MalfunctionMar 12, 2026Failure to Calibrate; Pressure Problem

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. THE TRILOGY 200 WAS RETURNED TO THE MANUFACTURER SERVICE CENTER FOR EVALUATION, AND THE DEVICE FAILED A DP CALIBRATION TEST STEP DURING TESTING. THE DEVICE'S SENSOR BOARD NEEDS REPLACED TO ADDRESS THE ISSUE. NO REPAIR PERFORMED, CUSTOMER HAS REQUESTED THAT DEVICE BE SCRAPPED. ADDITIONALLY, UNRELATED TO THE TEST FAIL, THE DEVICE WAS FOUND TO HAVE PORTING BLOCK PORT DAMAGE, THE UNIVERSAL PORTING BLOCK WAS FOUND DAMAGED, THE CORD RETAINER WAS MISSING/BROKEN, THE REAR CASE ENCLOSURE WAS DAMAGED, THE HANDLE WAS CRACKED AND THE AC CABLE WAS DAMAGED. NO REPAIR PERFORMED, CUSTOMER HAS REQUESTED THAT DEVICE BE SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24581497 ↗
• MalfunctionFeb 5, 2026Mechanical Problem; Failure to Calibrate

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE DEVICE FAILED THE ACTIVE EXHALATION PROPORTIONAL VALVE CLOSED, OPEN TEST STEP DURING TESTING. THE DEVICE'S ACTIVE EXHALATION CONTROLLER NEEDS REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, UNRELATED TO THE TEST FAIL, DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE DEVICE WAS FOUND TO HAVE MISSING/DISPLACED RUBBER FEET, THE ENCLOSURE FEET NEED REPLACED. ALSO, THE PORTING BLOCK PORT WAS FOUND TO BE PINCHED/DAMAGED, THE UNIVERSAL PORTING BLOCK NEEDS REPLACED AND THE CORD RETAINER WAS FOUND TO BE MISSING/BROKEN, THE CABLE CLAMP NEEDS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24269924 ↗
• MalfunctionJan 13, 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. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE DEVICE FAILED THE DP CALIBRATION TEST STEP DURING TESTING. THE DEVICE WAS RECALIBRATED TO ADDRESS THE ISSUE. ADDITIONALLY, UNRELATED TO THE DP CALIBRATION TEST FAILURE, THE UNIVERSAL PORTING BLOCK WAS FOUND TO BE DAMAGED AND THE POWER CORD CLAMP WAS FOUND TO BE MISSING. THE PORTING BLOCK AND POWER CORD CLAMP WERE REPLACED. ALSO, THE DEVICE INITIALLY FAILED THE O2 LOW FLOW TEST STEP DURING TESTING. UPON INSPECTION FOR O2 FAILURE, IT WAS DISCOVERED THAT THE GREY REMOVABLE FOAM WAS NOT CORRECTLY INSTALLED. REINSTALLED FOAM CORRECTLY AND DEVICE RETESTED. DEVICE PASSED O2 LOW FLOW TESTING AND NO MALFUNCTION WAS REPORTED. THERE WAS NO ISSUE PRIOR TO COMPONENTS BEING REPLACED DURING SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24056645 ↗
• MalfunctionDec 24, 2025Circuit Failure; Mechanical Problem; Failure to Calibrate; Circuit Failure; Mechanical Problem; Failure to Calibrate

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. 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, THE DEVICE FAILED THE DP PURGE VALVES TEST STEP DURING TESTING. THE DEVICE'S SYSTEM BOARD WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23888464 ↗
• MalfunctionDec 23, 2025Failure to Calibrate; Failure to Calibrate

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. 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, THE DEVICE FAILED THE POSITIVE FLOW VERIFICATION TEST STEP DURING TESTING. THE DEVICE WAS RECALIBRATED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23880566 ↗
• MalfunctionDec 22, 2025Circuit Failure; Failure to Calibrate; Circuit Failure; Failure to Calibrate

  A TRILOGY 200 VENTILATOR, CANADA - BT WAS RETURNED TO THE MANUFACTURER FOR ROUTINE PREVENTATIVE MAINTENANCE. THERE WAS NO ALLEGATION OF PATIENT HARM. THE DEVICE WAS NOT REPORTED TO BE IN PATIENT USE. THE TRILOGY 200 VENTILATOR, CANADA - BT DEVICE FAILED A DP PURGE VALVES TEST STEP DURING EVALUATION AT THE MANUFACTURER'S SERVICE CENTER. THE TECHNICIAN RECOMMENDED REPLACING THE DEVICE'S SENSOR BOARD TO ADDRESS THE ISSUE. THE REPAIR EVALUATION IS AWAITING CUSTOMER APPROVAL. 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 23871872 ↗
• MalfunctionDec 12, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING VENTILATION INOPERATIVE ERROR CODE WAS OBSERVED 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 SERVICE CENTER. DURING THE EVALUATION IT WAS NOTED THAT THE ERROR CODE, DSP MOTOR FAILURE (E-009), WAS OBSERVED ON THE DEVICE'S ERROR LOG. THE MANUFACTURER SERVICE TECHNICIAN FURTHER EVALUATED AND DETERMINED THE BLOWER AT THE FLOW PATH HAD CAUSED THE ISSUE TO OCCUR ON THE DEVICE. IN CONCLUSION, THE DEVICE'S BLOWER NEEDS REPLACED TO ADDRESS THE ISSUE. THE ROOT CAUSE IS CONFIRMED AT THIS TIME. A FINAL REPORT IS BEING SUBMITTED. SHOULD FURTHER INVESTIGATION PROVIDE NEW INFORMATION THAT IMPACTS THE OUTCOME OF THE INVESTIGATION OR THE ASSOCIATED MEDICAL DEVICE REPORTING, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, THE POWER CORD CLAMP WAS REPLACED DUE TO MISSING ON THE DEVICE, AND IT WAS UNRELATED TO THE REPORTABLE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23794184 ↗
• MalfunctionSep 1, 2021Failure to Recalibrate; Failure to Recalibrate

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR WAS FAILING A CALIBRATION TEST. THE DEVICE WAS NOT IN PATIENT USE. THE DEVICE HAS NOT YET 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 12409090 ↗
• MalfunctionJul 8, 2021Failure to Recalibrate; Failure to Recalibrate

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR FAILED A TEST STEP DURING TESTING. THE DEVICE WAS NOT IN PATIENT USE. THE VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE VENTILATOR'S INTERNAL TUBING WAS FOUND TO BE PINCHED, WHICH WOULD CAUSE THE DEVICE TO FAIL TESTING. THE DEVICE'S TUBING KIT WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12134779 ↗
• MalfunctionMay 5, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR FAILED A STEP DURING TESTING. THE DEVICE WAS NOT IN PATIENT USE. THE DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. 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 11778408 ↗
• MalfunctionFeb 25, 2019Application Program Problem; Application Program Problem

  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 VENTILATOR'S SOFTWARE WAS RE-LOADED AND THE SD CARD REFORMATTED TO ADDRESS THE ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8367043 ↗
• MalfunctionFeb 13, 2019Failure to Recalibrate; Application Program Problem; Therapeutic or Diagnostic Output Failure; Ventilation Problem in Device Environment; Failure to Recalibrate; Application Program Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE HAS NOT YET 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 Consequences Or Impact To Patient

  MAUDE report 8335589 ↗
• MalfunctionDec 19, 2018Circuit Failure; Circuit Failure

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR "SERVICE REQUIRED" ALARM CONDITION OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. THE VENTILATOR WAS RETURNED TO THE MANUFACTURER'S SERVICE CENTER FOR EVALUATION AND THE CUSTOMER'S COMPLAINT WAS CONFIRMED. THE DEVICE'S SENSOR BOARD WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8179443 ↗
• MalfunctionDec 12, 2018Unexpected Shutdown; Unexpected Shutdown

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR POWERED OFF WHILE PLUGGED INTO AC POWER. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. 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 Consequences Or Impact To Patient

  MAUDE report 8154980 ↗
• MalfunctionDec 12, 2018No Display/Image; No Display/Image

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR 'S DISPLAY SCREEN WAS DAMAGED. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. 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 Consequences Or Impact To Patient

  MAUDE report 8154974 ↗
• MalfunctionDec 12, 2018Temperature Problem; Temperature Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR WAS ALARMING FOR A HIGH TEMPERATURE ALARM CONDITION. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. 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 Consequences Or Impact To Patient

  MAUDE report 8154968 ↗
• MalfunctionJun 20, 2018Device Inoperable; Device Displays Incorrect Message; Device 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 SYSTEM BOARD WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7619639 ↗
• MalfunctionDec 5, 2017Failure to Charge; Battery Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE DEVICE'S BATTERY WAS NOT CHARGING CORRECTLY. THE DEVICE WAS NOT IN PATIENT USE. THE DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. 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 Patient Involvement

  MAUDE report 7083916 ↗
• MalfunctionSep 26, 2017Failure to Charge; Failure to Charge

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR FAILS TO CHARGE ITS INTERNAL BATTERY. THERE WAS NO HARM OR INJURY REPORTED. REPEATED ATTEMPTS TO HAVE THE DEVICE AND COMPONENTS RETURNED FOR EVALUATION AND INVESTIGATION WERE UNSUCCESSFUL. THE MANUFACTURER BELIEVES THEY WILL BE UNABLE TO GATHER ADDITIONAL INFORMATION. THE MANUFACTURER IS SUBMITTING A FINAL REPORT AT THIS TIME. IF PERTINENT INFORMATION BECOMES AVAILABLE TO THE MANUFACTURER AT A LATER DATE, AN ADDENDUM TO THIS FINAL REPORT WILL BE FILED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6893634 ↗
• MalfunctionSep 26, 2017Aborted Charge; Aborted Charge

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR WAS NOT CHARGING ITS BATTERY TO FULL CAPACITY. THERE WAS NO HARM OR INJURY REPORTED. REPEATED ATTEMPTS TO HAVE THE DEVICE AND COMPONENTS RETURNED FOR EVALUATION AND INVESTIGATION WERE UNSUCCESSFUL. THE MANUFACTURER BELIEVES THEY WILL BE UNABLE TO GATHER ADDITIONAL INFORMATION. THE MANUFACTURER IS SUBMITTING A FINAL REPORT AT THIS TIME. IF PERTINENT INFORMATION BECOMES AVAILABLE TO THE MANUFACTURER AT A LATER DATE, AN ADDENDUM TO THIS FINAL REPORT WILL BE FILED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6893615 ↗
• MalfunctionMar 22, 2017Device Operational Issue; Device Operational Issue

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A "SERVICE REQUIRED" ALARM CONDITION OCCURRED. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, "SERVICE REQUIRED" CODES WERE FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S POWER MANAGEMENT BOARD WAS REPLACED TO ADDRESS THE ISSUES.

  Patient problems: No Patient Involvement

  MAUDE report 6423996 ↗