Trilogy 100 Trilogy100 Ventilator, Bluetooth, CanadaRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00606959026377), received between Mar 13, 2019 and Sep 29, 2026 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Failure to Calibrate” (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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Electrical /Electronic Property Problem; Mechanical Problem; Failure to Recalibrate

  The Trilogy 100 Ventilator was returned to the third-party service center for remediation. The device was not in use on a patient at the time of the occurrence.During the evaluation the device failed a test step for Active Exhalation Purge Valve Closed during testing. In conclusion the Active Exhalation Control Module was replaced to address the issue. The device was tested and passed all test.Additionally, during the service of the device, components were replaced as part of maintenance of the device and due to physical/cosmetic damage. This device been serviced, inspected, tested, met acceptance criteria in accordance with all the applicable customer requirements as defined in the contractual agreement with Plexus. The Device History Record has been reviewed and approved by Plexus Quality Assurance.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50930260 ↗
• MalfunctionMay 27, 2026No Display/Image

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE SCREEN DOES NOT WORK ON A TRILOGY 100 DEVICE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. THE TRILOGY 100 DEVICE 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 LIQUID CRYSTAL DISPLAY (LCD) DISPLAY WAS SUSPECTED OF CAUSING THE SCREEN NOT TO TURN ON FOR THE TRILOGY 100 DEVICE. IN CONCLUSION, THE DEVICE'S LCD SCREEN, LCD BACKLIGHT CABLE, AND LCD RIBBON CABLE WERE REPLACED TO ADDRESS THE ISSUE. THE ROOT CAUSE IS CONFIRMED AT THIS TIME. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, THE KEYPAD, FRONT ENCLOSURE, AND REAR ENCLOSURE WERE REPLACED FOR PHYSICAL DAMAGE UNRELATED TO THE REPORTABLE ISSUE. THE DEVICE PASSED ALL FINAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25306967 ↗
• MalfunctionMay 14, 2026Failure to Calibrate; Battery Problem

  A TRILOGY 100 WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING EVALUATION OF THE DEVICE, THE TRILOGY 100 VENTILATOR FAILED A TEST STEP RELATED TO A BATTERY CELL UNDER-VOLTAGE INSIDE THE BATTERY PACK. NO INFORMATION ABOUT COMPONENT REPLACEMENT WAS PROVIDED IN THE EVALUATION. 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 25175497 ↗
• MalfunctionMay 6, 2026Circuit Failure; Failure to Calibrate

  A TRILOGY 100 WAS RETURNED TO A THIRD-PARTY SERVICE CENTER 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 THIRD-PARTY SERVICE CENTER, THE DEVICE FAILED A FLOW CALIBRATION 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 25094295 ↗
• MalfunctionApr 23, 2026Electrical /Electronic Property Problem; Battery Problem

  THE TRILOGY 100 VENTILATOR WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR REMEDIATION. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. DURING THE EVALUATION OF THE DEVICE ERROR CODES IN RELATION TO CELL UNDERVOLTAGE AND INT_LI_ION_DEPLETED WERE OBSERVED IN THE DEVICE EVENT LOG. THE TECHNICIAN CONFIRMED THAT THERE WERE NO FUNCTIONAL ISSUES DETECTED AND NO PARTS WERE REPLACED IN REGARD TO THE ERROR CODES OBSERVED. THE DEVICE PASSED ALL TEST. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, COMPONENTS WERE ONLY REPLACED AS PART OF MAINTENANCE OF THE DEVICE OR DUE TO COSMETIC/PHYSICAL DAMAGE UNRELATED TO THE REPORTABLE MALFUNCTION/ISSUE. THIS DEVICE BEEN SERVICED, INSPECTED, TESTED, MET ACCEPTANCE CRITERIA IN ACCORDANCE WITH ALL THE APPLICABLE CUSTOMER REQUIREMENTS AS DEFINED IN THE CONTRACTUAL AGREEMENT WITH PLEXUS. THE DEVICE HISTORY RECORD HAS BEEN REVIEWED AND APPROVED BY PLEXUS QUALITY ASSURANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24964485 ↗
• MalfunctionApr 21, 2026Mechanical Problem; Failure to Calibrate

  THE TRILOGY 100 WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER 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 THIRD-PARTY SERVICE CENTER, THE DEVICE FAILED AN ACTIVE EXHALATION PROPORTIONAL VALVE OPENED TEST STEP DURING TESTING. THE DEVICE'S ACTIVE EXHALATION CONTROL MODULE (AECM) WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24943282 ↗
• MalfunctionApr 17, 2026Failure to Calibrate

  THE MANUFACTURER RECEIVED A REPORT THAT A TRILOGY 100 VENTILATOR WAS RETURNED FOR SERVICE. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE DEVICE WAS EVALUATED AT A THIRD-PARTY SERVICE CENTER. DURING INITIAL INSPECTION, THE RUBBER FEET WERE FOUND TO BE MISSING, THE FRONT CASE WAS CRACKED, AND THE REAR ENCLOSURE ASSEMBLY WAS DAMAGED. DUE TO THE REAR ENCLOSURE REPLACEMENT, THE ENCLOSURE SEAL KIT WAS ALSO REPLACED. DURING FUNCTIONAL TESTING, THE DEVICE FAILED THE ACTIVE EXHALATION PROPORTIONAL VALVE TEST. AVAILABLE SERVICE DOCUMENTATION DID NOT INDICATE THAT REPLACEMENT OF ANY COMPONENTS WAS REQUIRED TO ADDRESS THIS FAILURE. 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 24911147 ↗
• MalfunctionFeb 12, 2026Failure to Charge; Battery 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 INTERNAL BATTERY WAS REPLACED TO ADDRESS THE ISSUE. THE DEVICE PASSED ALL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24327243 ↗
• MalfunctionNov 17, 2025Failure to Calibrate; Failure to Calibrate

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE ACTIVE EXHALATION DIFFERENTIAL PRESSURE PURGE TEST HAD FAILED ON A TRILOGY 100 DEVICE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. THE TRILOGY 100 DEVICE WAS EVALUATED AT THE MANUFACTURER SERVICE CENTER. DURING THE EVALUATION IT WAS NOTED THAT THE DEVICES BLOWER TRANSITION TUBE WAS DISCONNECTED CAUSING THE TEST STEP TO FAIL ON THE DEVICE. IN CONCLUSION, THE DEVICE'S BLOWER TRANSITION TUBE WAS RECONNECTED TO ADDRESS THE ISSUE. THE ROOT CAUSE IS CONFIRMED AT THIS TIME. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, THE CHECK LEAK STEP TEST HAD FAILED, WHICH WAS RESOLVE BY RECONNECTING THE BLOWER TRANSITION TUBE ON THE DEVICE. THIS ISSUE WAS UNRELATED TO THE REPORTABLE ISSUE. THE RUBBER FEET WERE REPLACED FOR MISSING ON THE DEVICE. THE ISSUE WAS UNRELATED TO THE REPORTABLE ISSUE. THE DEVICE PASSED ALL FINAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23576075 ↗
• MalfunctionNov 17, 2025Failure to Calibrate; Failure to Calibrate

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE HW POWER FAIL TEST STEP HAD FAILED ON THE TRILOGY 100 DEVICE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. THE TRILOGY 100 DEVICE WAS EVALUATED AT THE MANUFACTURER SERVICE CENTER. DURING THE EVALUATION IT WAS NOTED THAT THE MANUFACTURER'S SERVICE TECHNICIAN CONFIRMED THERE WAS NO PROBLEM DETECTED ON THE DEVICE. THERE WAS NO PART(S) REPLACED AND/OR NO REPAIR WERE MADE FOR THIS ISSUE ON THE DEVICE. THE ROOT CAUSE ISN'T CONFIRMED AT THIS TIME. THE DEVICE WAS RETESTED AND PASSED ALL FINAL TESTING. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, THE POWER CORD CLAMP WAS REPLACED FOR MISSING ON THE DEVICE, WHICH WAS UNRELATED TO THE REPORTABLE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23576038 ↗
• MalfunctionDec 28, 2021Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A VENTILATOR'S SOUND ABATEMENT FOAM. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13094975 ↗
• MalfunctionSep 27, 2021Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A VENTILATOR'S SOUND ABATEMENT FOAM. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12538268 ↗
• MalfunctionMay 6, 2021Failure to Charge; Battery Problem; Failure to Charge; Battery Problem

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. 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 EVENT LOG. THE DEVICE'S INTERNAL BATTERY NEEDS TO BE REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11784224 ↗
• MalfunctionDec 10, 2020Failure to Power Up; Insufficient Device Problem Information; Failure to Power Up; Insufficient Device Problem Information

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR'S FAILED TO POWER ON. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 10985167 ↗
• MalfunctionApr 24, 2019Application Program Problem; Application Program Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR WAS CONSTANTLY ALARMING. 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 SOFTWARE WAS RELOADED TO ADDRESS THE ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8543783 ↗
• MalfunctionMar 13, 2019Failure 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 STEP DURING TESTING. THE DEVICE'S SENSOR BOARD WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8416600 ↗