Trilogy Trilogy200 Ventilator, United StatesRecalls & reported problems

Summary

The FDA's MAUDE database contains 282 adverse event reports that list this exact device (DI 00606959022737), received between Sep 23, 2015 and Sep 28, 2026 — classified as 4 deaths, 1 injury, 277 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (58 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 25 most recent of 282 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Mechanical Problem; Failure to Calibrate

  A Trilogy 200 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 reported to be in patient use.During the evaluation of the device at the third-party service center, the device failed a flow-related test step during testing. The device's active exhalation control module was replaced to address the issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50918627 ↗
• MalfunctionJun 25, 2026Failure to Calibrate; Battery Problem; Pressure Problem

  A TRILOGY 200 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 REPORTED TO BE IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE DEVICE FAILED A DIFFERENTIAL PRESSURE CALIBRATION TEST STEP DURING TESTING. THE DEVICE'S TUBING LENGTH WAS ADJUSTED TO ADDRESS THE ISSUE. THE DEVICE WAS RE-TESTED AND THE DEVICE FAILED TESTING DUE RECEIVING AN ERROR CODE RELATED TO THE BATTERY. ERR_BATT_LOW_STATE_OF_HEALTH_INT_LI_ION NOTIFIES THE USER THAT THE BATTERY LIFE HAS DECLINED. THE BATTERY IS STILL FUNCTIONING AND AC POWER CAN ALSO BE USED; HOWEVER, THE BATTERY IS NOT FUNCTIONING TO SPECIFICATION. THE DEVICE'S INTERNAL BATTERY WAS REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, THE DEVICE FAILED A NON-REPORTABLE TEST STEP RELATED TO THE DETACHABLE BATTERY DURING TESTING. CHECK DETACHABLE BATTERY CAPACITY TEST CHECKS IF THE BATTERY IS CHARGED TO A PARTICULAR LEVEL REQUIRED BY THE TEST, DOES NOT AFFECT THERAPY. THE DEVICE NEEDS NEW EXTERNAL BATTERY TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25622639 ↗
• MalfunctionJun 3, 2026Failure to Calibrate

  THE MANUFACTURER RECEIVED A REPORT THAT A TRILOGY 200 VENTILATOR WAS RETURNED FOR SERVICE. NO PATIENT INJURY OR SERIOUS HARM WAS REPORTED. DURING EVALUATION AT A THIRD-PARTY SERVICE CENTER, THE POWER CORD CLAMP, HANDLE ASSEMBLY, AND RUBBER FEET WERE FOUND TO BE MISSING. THE BASE ENCLOSURE KIT WAS CRACKED. THE UNIVERSAL PORTING BLOCK, FRONT CASE, AND ENCLOSURE SEAL KIT WERE DAMAGED. THE WARNING LABEL REQUIRED REPLACEMENT DUE TO REPLACEMENT OF THE BASE ENCLOSURE, AND THE THTPOL LABEL WAS REPLACED BECAUSE IT WAS OBSOLETE FOLLOWING A REVISION. DURING FUNCTIONAL TESTING, THE DEVICE FAILED THE 120-VAC POWER SOURCE PEAK POWER TEST. SERVICE RECORDS INDICATED THAT THE FAILURE WAS VALIDATED. AN ACTIVE EXHAUST PURGE VALVE CLOSED FAULT RECURRED DURING TESTING, AND A DAMAGED HOSE WAS IDENTIFIED. SERVICE RECORDS DID NOT DOCUMENT REPLACEMENT OF A SPECIFIC COMPONENT ASSOCIATED WITH THE FAILED TESTING. FOLLOWING REPAIR AND REPLACEMENT ACTIVITIES, THE DEVICE SUCCESSFULLY PASSED ALL REQUIRED FUNCTIONAL AND PERFORMANCE TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25375258 ↗
• MalfunctionJun 2, 2026Failure to Calibrate; Device Sensing Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE ACTIVE EXHALATION PURGE AND PROPORTIONAL VALVE TEST STEPS HAD FAILED ON A TRILOGY 200 DEVICE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. DURING THE EVALUATION IT WAS NOTED THAT THE DEVICES ACTIVE EXHALATION CONTROL MODULE (AECM) HAD CAUSED THE TEST CASES TO FAIL ON THE TRILOGY 200 DEVICE. IN CONCLUSION, THE DEVICE'S AECM WAS REPLACED TO ADDRESS THE ISSUE. THE ROOT CAUSE IS CONFIRMED AT THIS TIME. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, THE FRONT, BASE AND REAR ENCLOSURES, KEYPAD, DC CABLE, AND HANDLE WERE REPLACED FOR PHYSICAL DAMAGE UNRELATED TO THE REPORTABLE ISSUE. THE RUBBER FEET WERE REPLACED FOR MISSING ON THE DEVICE. THIS WAS UNRELATED TO THE REPORTABLE ISSUE. THE DEVICE PASSED ALL FINAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25363514 ↗
• MalfunctionJun 1, 2026Failure to Calibrate

  THE MANUFACTURER RECEIVED A REPORT THAT A TRILOGY 200 VENTILATOR WAS RETURNED FOR SERVICE. NO PATIENT INJURY OR SERIOUS HARM WAS REPORTED. DURING EVALUATION AT A THIRD-PARTY SERVICE CENTER, THE POWER CORD CLAMP, HANDLE O-RING KIT, AND RUBBER FEET WERE NOTED TO BE MISSING. THE REAR ENCLOSURE ASSEMBLY AND HANDLE ASSEMBLY WERE OBSERVED TO BE CRACKED. THE BASE ENCLOSURE KIT WAS BROKEN. THE ENCLOSURE SEAL KIT WAS DAMAGED. THE WARNING LABEL REQUIRED REPLACEMENT DUE TO A CHANGE IN THE BASE ENCLOSURE. THE LABEL THTPOL WAS OBSOLETE DUE TO A REVISION. DURING FUNCTIONAL TESTING, THE DEVICE FAILED THE DIFFERENTIAL PRESSURE (DP) PURGE VALVES TEST. EVALUATION NOTED A CRUSHED SENSOR TUBE AND DAMAGE TO THE EXTERNAL BATTERY CONNECTOR. SERVICE RECORDS DID NOT DOCUMENT REPLACEMENT OF A SPECIFIC COMPONENT TO ADDRESS THE DP PURGE VALVES TEST FAILURE. FOLLOWING REPAIR AND REPLACEMENT ACTIVITIES, THE DEVICE SUCCESSFULLY PASSED ALL REQUIRED FUNCTIONAL AND PERFORMANCE TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25350113 ↗
• MalfunctionMay 28, 2026Mechanical Problem; Failure to Calibrate

  A TRILOGY 200 VENTILATOR MANUFACTURED IN THE U.S.A. WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR ROUTINE PREVENTATIVE MAINTENANCE. THERE WAS NO ALLEGATION OF PATIENT HARM, AND THE DEVICE WAS NOT REPORTED TO BE IN PATIENT USE AT THE TIME OF RETURN. DURING EVALUATION AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE FAILED THE DP NULL VALVE TEST STEP. INVESTIGATION IDENTIFIED THE ISSUE WITH THE ACTIVE EXHALATION CONTROL MODULE (AECM), WHICH WAS REPLACED TO ADDRESS THE FAILURE. ADDITIONALLY, THE MISSING RUBBER FEET, ENCLOSURE SEAL KIT, AND HANDLE O-RING WERE REPLACED. THE LABEL THTPOL 44.5 X 50.8 MM WHT WAS ALSO REPLACED DUE TO AN OBSOLETE REVISION. FOLLOWING SERVICE, THE DEVICE WAS INSPECTED AND TESTED AND MET ALL APPLICABLE ACCEPTANCE CRITERIA AND CUSTOMER REQUIREMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25326049 ↗
• MalfunctionMay 27, 2026Calibration Problem

  THE MANUFACTURER RECEIVED INFORMATION THAT A TRILOGY 200 VENTILATOR DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. DURING THE EVALUATION, THE SERVICE TECHNICIAN OBSERVED A VERIFY DIFFERENTIAL PRESSURE SENSOR CALIBRATION FAILURE. NO DOCUMENTATION OF A REPLACED COMPONENT TO ADDRESS THE ISSUE. ADDITIONALLY, THE HANDLE O-RING KIT WAS MISSING, THE RUBBER FEET WERE MISSING, THE FRONT ENCLOSURE KIT WAS CRACKED, THE REAR ENCLOSURE ASSEMBLY WAS CRACKED, THE ENCLOSURE SEAL KIT AND PORTING BLOCK ADAPTER KIT REARS NEEDED CHANGED, THE EXHALATION PORT BLOCK WAS CRACKED AND PINCHED, AND THE LABEL WAS UNACCEPTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25303565 ↗
• MalfunctionMay 27, 2026Mechanical Problem; Failure to Calibrate

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE DIFFERENTIAL PRESSURE (DP) CALIBRATION TEST STEPS HAD FAILED ON THE TRILOGY 200 DEVICE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. DURING THE EVALUATION IT WAS NOTED THAT THE DEVICES TUBES LEADING TO THE PORTING BLOCK WERE IMPROPERLY ASSEMBLED CAUSING THE DP CALIBRATION TEST STEPS TO FAIL ON THE DEVICE. IN CONCLUSION THE TUBES WERE REASSEMBLED TO ADDRESS THE ISSUE. THE ROOT CAUSE IS CONFIRMED AT THIS TIME. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, THE REAR ENCLOSURE ASSEMBLY, ENCLOSURE SEAL, AND KEYPAD WERE REPLACED FOR PHYSICAL DAMAGE UNRELATED TO THE REPORTABLE ISSUE. THE RUBBER FEET WERE REPLACED DUE TO MISSING ON THE DEVICE. THIS WAS UNRELATED TO THE REPORTABLE ISSUE. THE DEVICE PASSED ALL FINAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25299047 ↗
• MalfunctionMay 20, 2026Failure to Calibrate

  A TRILOGY 200 WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION THE DEVICE FAILED A POSITIVE FLOW VERIFICATION TEST STEP DURING TESTING. THERE IS NO DOCUMENTATION OF ANY RESOLUTION FOR THIS ISSUE. ADDITIONALLY, NOT RELATED TO THE REPORTABLE ISSUE, SEVERAL COMPONENTS WERE REPLACED DUE TO MISSING/PHYSICAL DAMAGE. THE DEVICE WAS TESTED AND PASSED ALL FINAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25228266 ↗
• MalfunctionMay 20, 2026Mechanical Problem; Failure to Calibrate

  A TRILOGY 200 WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION THE DEVICE FAILED A TEST STEP INDICATING THE ACTIVE EXHALATION PROPORTIONAL VALVE WAS OPEN. THE DEVICE'S ACTIVE EXHALATION CONTROL MODULE WAS REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, NOT RELATED TO THE REPORTABLE ISSUE, SEVERAL COMPONENTS WERE REPLACED DUE TO MISSING/PHYSICAL DAMAGE. THE POWER MANAGEMENT BOARD WAS ALSO REPLACED. THERE WAS NO DOCUMENTATION OF A MALFUNCTION OR TEST FAILURE FOR THIS COMPONENT REPLACEMENT. THE DEVICE WAS TESTED AND PASSED ALL FINAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25228261 ↗
• MalfunctionMay 18, 2026Failure to Calibrate

  A TRILOGY 200 WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION THE DEVICE FAILED A PRESSURE SENSOR CALIBRATION TEST STEP. THERE IS NO DOCUMENTATION OF ANY COMPONENTS BEING REPLACED NOR A RESOLUTION. SEVERAL COMPONENTS WERE REPLACED DUE TO PHYSICAL DAMAGE OR MISSING. A FINAL REPORT IS BEING SUBMITTED. IF NEW INFORMATION BECOMES AVAILABLE 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 25204477 ↗
• MalfunctionMay 6, 2026Failure to Calibrate; Battery Problem

  THE TRILOGY 200 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 FOUR TEST STEPS DURING TESTING. THE FOUR TEST STEPS WERE CHECK LEAK, INTERNAL BATTERY, PURGE VALVE CLOSED AND PROPORT VALVE OPENED. THE DEVICE HAS BEEN RETURNED AND EVALUATED BY A THIRD PARTY SERVICE CENTER. THE BATTERY WAS REPLACED DUE TO THE DAMAGE AND THE TUBING WAS RECONNECTED DUE TO THE INCORRECT CONNECTION DETECTED. AFTER REPLACING THE BATTERY AND RECONNECTING THE TUBING, THE ADDITIONAL TEST STEP FAILURES DID NOT HAPPEN AGAIN AND THE DEVICE PASSED ALL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25093560 ↗
• MalfunctionJan 20, 2026Failure 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 FOR DP PURGE VALVES DURING TESTING. DEVICE PASSED ALL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24121848 ↗
• MalfunctionJan 16, 2026Electrical /Electronic Property Problem; Battery Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING VENTILATOR SERVICE REQUIRED ERROR CODE WAS FOUND 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, INTERNAL BATTERY PERMANENT FAILURE (E-0193), WAS OBSERVED ON THE DEVICE'S ERROR LOG. THE MANUFACTURER'S SERVICE TECHNICIAN EVALUATED AND DETERMINED THE INTERNAL BATTERY HAD CAUSED THE ERROR CODE TO OCCUR ON THE DEVICE. IN CONCLUSION, THE DEVICE'S INTERNAL BATTERY NEEDS REPLACED TO ADDRESS THE ISSUE. THE DEVICE WAS SCRAPPED PER THE CUSTOMER REQUEST. THE ROOT CAUSE IS CONFIRMED AT THIS TIME. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, THE RUBBER FEET NEED REPLACED FOR MISSING ON THE DEVICE, WHICH WAS UNRELATED FOR THE REPORTABLE ISSUE. ANOTHER ERROR CODE, URGENT REMINDER (E-0290), WAS OBSERVED ON THE DEVICE'S ERROR LOG AND THE INTERNAL BATTERY NEEDS REPLACED TO ADDRESS THE ISSUE. THE FRONT ENCLOSURE CASE NEEDS REPLACED FOR PHYSICAL DAMAGE UNRELATED TO THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24100602 ↗
• MalfunctionJan 16, 2026Electrical /Electronic Property Problem; Mechanical Problem

  A TRILOGY 200 VENTILATOR, U.S.A. WAS RETURNED TO THE MANUFACTURER FOR ROUTINE PREVENTATIVE MAINTENANCE. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. THE DEVICE WAS NOT REPORTED TO BE IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, A VENTILATOR INOPERATIVE ERROR CODE WAS OBSERVED. THE TECHNICIAN RECOMMENDED REPLACING THE DEVICE'S BLOWER TO ADDRESS THE ISSUE. ADDITIONALLY, UNRELATED TO THE ISSUE THE DEVICE'S FEET ARE MISSING, THE D/C CABLE AND THE REAR CASE ENCLOSURE ARE DAMAGED AND WILL NEED TO BE REPLACED. NO REPAIR PERFORMED. THE DEVICE IS NOT NEEDED FOR INVENTORY AND HAS BEEN SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24099110 ↗
• MalfunctionJan 14, 2026Circuit 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 O2 LOW FLOW TEST STEP DURING TESTING. THE DEVICE'S ACTIVE EXHALATION CONTROLLER WAS REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, UNRELATED TO THE TEST FAILURE, THE DEVICE WAS FOUND TO HAVE THE CORD RETAINER MISSING/BROKEN AND HAD MISSING/DISPLACED RUBBER FEET. CORD RETAINER AND RUBBER FEET REPLACED. ALSO, EXTERIOR DAMAGE WAS FOUND TO THE FRONT, REAR, AND BASE ENCLOSURES. ENCLOSURES REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24068759 ↗
• MalfunctionJan 13, 2026Circuit 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. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE DEVICE FAILED THE ACTIVE EXHALATION PURGE VALVE CLOSED TEST STEP DURING TESTING. THE DEVICE'S ACTIVE EXHALATION CONTROL MODULE WAS REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, UNRELATED TO THE TEST FAILURE, THE DEVICE WAS FOUND TO HAVE MISSING/DISPLACED RUBBER FEET, RUBBER FEET WERE REPLACED. THE DEVICE WAS FOUND TO HAVE MISSING/BROKEN CORD RETAINER, SO THE CORD RETAINER WAS REPLACED. THERE WAS PHYSICAL DAMAGE FOUND TO THE FRONT AND REAR ENCLOSURE SO THE ENCLOSURES WERE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24056788 ↗
• MalfunctionJan 12, 2026Failure 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 OXYGEN LOW FLOW, PRESSURE SENSORS CAL PROXIMAL FAILURE, DP PURGE VALVE TEST DURING TESTING. THE SERVICE TECHNICIAN DETERMINED THE GREY REMOVABLE FOAM ADJUSTMENT WAS NECESSARY. THE FOAM WAS ADJUSTED. ADDITIONALLY, TUBING AND SENSOR BOARD WAS REPLACED TO ADDRESS THE ISSUE. THE DEVICE PASSED ALL THE TESTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24049585 ↗
• MalfunctionDec 30, 2025Display or Visual Feedback Problem; Failure to Recalibrate; Display or Visual Feedback 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 TEST STEP DURING TESTING ALONG WITH LCD SCREEN IS FLICKERING. THE DEVICE'S LCD SCREEN WAS REPLACED TO ADDRESS THE ISSUE. THE UNIT HAS BEEN RECALIBRATED. THE DEVICE PASSED ALL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23926400 ↗
• MalfunctionDec 19, 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. THE DEVICE WAS RETESTED AND FAILED THE DP PURGE VALVES TEST STEP DURING TESTING. THE SENSOR BOARD NEEDS REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, UNRELATED TO THE TEST FAILURES, THE DEVICE WAS FOUND TO HAVE MISSING/DISPLACE RUBBER FEET AND THE PORTING BLOCK WAS DAMAGED. RUBBER FEET AND THE PORTING BLOCK NEEDS TO BE REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23851727 ↗
• MalfunctionDec 4, 2025Electrical /Electronic Property Problem; Mechanical Problem; Electrical /Electronic Property Problem; Mechanical Problem

  THE MANUFACTURER RECEIVED INFORMATION THAT A TRILOGY 200 VENTILATOR WAS RETURNED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE DEVICE IS BEING RETURNED FOR FOAM REPLACEMENT PER FSCA 2021-05-A. THERE WAS NO PATIENT INVOLVEMENT, AND NO HARM OR INJURY REPORTED. EVALUATION OF THE DEVICE CONFIRMED A VENTILATOR INOPERATIVE MESSAGE. NO ADDITIONAL INFORMATION REGARDING THE VENTILATOR INOPERATIVE MESSAGE IS AVAILABLE AT THIS TIME. ADDITIONAL FINDINGS NOT RELATED TO THE MALFUNCTION/VENTILATOR INOPERATIVE ISSUE: THE RUBBER FEET WERE MISSING FROM THE DEVICE AND WOULD NEED TO BE REPLACED. THE DEVICE HAD AN SAFETY DATA CARD READ FAILURE THAT WOULD REQUIRE REPLACEMENT OF THE SYSTEM AND CENTRAL PROCESSING UNIT CIRCUIT BOARD ASSEMBLIES. THE REAR CASE ENCLOSURE WILL NEED TO BE REPLACED DUE TO PHYSICAL DAMAGE. THE HANDLE KIT WILL NEED TO BE REPLACED DUE TO DETACHING HANDLE GRIP /PHYSICAL DAMAGE. THE BLOWER MOTOR IS SEIZED UP AND WILL NOT ROTATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23714098 ↗
• MalfunctionNov 25, 2025Circuit Failure; Failure to Calibrate; Circuit Failure; Failure to Calibrate

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE DIFFERENTIAL PRESSURE CALIBRATION 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 BY THE MANUFACTURER SERVICE CENTER. DURING THE EVALUATION IT WAS NOTED THAT THE NOZZLE ON THE SENSOR BOARD HAD PHYSICAL DAMAGE THAT WAS CAUSED BY SERVICE. IN CONCLUSION, THE DEVICE'S SENSOR PRINTED CIRCUIT ASSEMBLY (PCA) BOARD WAS REPLACED TO ADDRESS THE ISSUE. THE ROOT CAUSE IS CONFIRMED AT THIS TIME. THE MANUFACTURER'S EVALUATION IS STILL ONGOING DUE TO THE DEVICE NEEDS TO BE RETESTED AFTER THE PARTS HAD BEEN REPLACED ON THE DEVICE. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, THE DC CABLE WAS REPLACED FOR PHYSICAL DAMAGE UNRELATED TO THE REPORTABLE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23649546 ↗
• MalfunctionNov 24, 2025Material Separation; Failure to Calibrate; Material Separation; Failure to Calibrate

  A TRILOGY 200 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 TESTING FOR OXYGEN (O2) LOW FLOW. THE DEVICE'S GREY REMOVABLE FOAM WAS ADJUSTED. THE DEVICE WILL BE RETESTED. THE DEVICE ALSO FAILED A HARDWARE POWER FAIL TEST, THE DEVICE WAS RECALIBRATED TO ADDRESS THE ISSUE. ADDITIONALLY, NOT RELATED TO THE ABOVE ISSUE, THE BLOWER ASSEMBLY, BLOWER FILTER INLET FILTER WERE REPLACED PREVENTATIVELY AND THE OUTER ENCLOSURE WAS CLEANED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23637487 ↗
• MalfunctionNov 18, 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 POSITIVE FLOW. THE DEVICE PASSED ALL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23584923 ↗
• MalfunctionOct 30, 2025Battery Problem; Battery Problem

  A TRILOGY 200 VENTILATOR WAS RETURNED TO THE MANUFACTURER'S SERVICE CENTER FOR COMPLETION DEVICE EVALUATION. THERE WAS NO INJURY OR HARM REPORTED. DURING RUN-IN, THE DEVICE ALARMED FOR ERROR CODE E-193 WAS NOTED IN THE ERROR LOG CAUSING A VENTILATOR SERVICE REQUIRED ALARM AND "INTERNAL BATTERY DEPLETED" ALARMS. REPLACEMENT OF THE INTERNAL BATTERY IS REQUIRED TO REMEDY THIS ISSUE. ADDITIONAL FINDINGS NOT RELATED TO THE MALFUNCTION/ISSUE: DURING EVALUATION, IT WAS NOTED THE SN/MN LABEL AND WAS REPLACED DUE TO HAVING THE INCORRECT GTIN/REVISION. THE RUBBER FEET WERE MISSING AND REQUIRED REPLACEMENT. THE CORD RETAINER WAS MISSING AND REQUIRED REPLACEMENT. THE REAR CASE SEAM GASKET WAS DAMAGED AND REQUIRED REPLACEMENT. A "VENTILATOR SERVICE REQUIRED" FOR CHECK CIRCUIT, LOW EXPIRATORY, HIGH EXPIRATORY AND INTERNAL BATTERY DEPLETED. UPON INVESTIGATION, THE TRANSITION TUBE WAS FOUND TO NOT BE CONNECTED TO THE FLOW SENSOR WHICH CAUSED THE "CHECK CIRCUIT, LOW EXPIRATORY AND HIGH EXPIRATORY" ALARMS. THE TRANSITION TUBE WAS RE-CONNECTED AND THE DEVICE RE-ASSEMBLED TO ADDRESS THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23426102 ↗