Trilogy Trilogy O2 Ventilator JapanRecalls & reported problems

Summary

The FDA's MAUDE database contains 1,900 adverse event reports that list this exact device (DI 00606959025394), received between Sep 30, 2015 and Jun 24, 2026 — classified as 7 deaths, 12 injuries, 1,881 malfunctions.

The most frequently reported specific device problem is “Circuit Failure” (1,073 reports).

3 other recalls cover devices cleared under the same FDA submission (K093905); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 1,900 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 24, 2026Circuit Failure; Electrical /Electronic Property Problem; Device Sensing Problem

  THE TRILOGY O2 VENTILATOR WAS RETURNED TO THE MANUFACTURER SERVICE CENTER FOR PREVENTATIVE MAINTENANCE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. DURING THE EVALUATION IT WAS CONFIRMED BY AN OPERATIONAL CHECK THAT "VENTILATOR SERVICE REQUIRED" ALARM SOUNDED. ERROR CODE 344 (LOW FLOW) INDICATING A FAILURE IN THE AIR FLOW SENSOR, WAS RECORDED IN THE ERROR LOG, THEREFORE THE OXYGEN BLENDER BOARD EQUIPPED WITH THE AIR FLOW SENSOR WAS REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, PERIODIC MAINTENANCE 1 WAS PERFORMED. THE FOLLOWING PARTS WERE REPLACED AS REGULATED BY MAINTENANCE PROCEDURE TO PREVENT FAILURE: TRILOGY O2 PM1 KIT. THE TECHNICIAN PERFORMED REPAIR TEST, ALARM CHECK, BATTERY CHECK, RUN IN TESTS, CLEANING THEN CONFIRMED THE UNIT OPERATED PROPERLY. THE SOFTWARE VERSION WAS CONFIRMED (VER.14.2.05).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25609900 ↗
• MalfunctionJun 9, 2026Electrical /Electronic Property Problem; Unexpected Shutdown

  THE MANUFACTURER RECEIVED INFORMATION FROM A NURSE ALLEGING THAT AFTER A PATIENT EXPERIENCED A LOW INSPIRATORY PRESSURE ALARM AND CIRCUIT DISCONNECT ALARM, THE TRILOGY 100 DEVICE HAD STOPPED OPERATING FOR FORTY-FIVE (45) SECONDS, A TIME BASED ON THE NURSE'S PERCEPTION. THE NURSE STATED THAT ALTHOUGH THE SCREEN WAS ON, IT WAS UNKNOWN WHAT WAS INDICATED ON THE MONITOR VALUES. THE DEVICE WAS REPLACED WITH ANOTHER ONE. THERE WAS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS SPECIFIED BY THE PATIENT. THE TRILOGY 100 DEVICE WAS RETURNED TO THE MANUFACTURER SERVICE CENTER FOR EVALUATION, AND THE CUSTOMER¿S COMPLAINT WAS NOT CONFIRMED. DURING THE EVALUATION IT WAS NOTED THAT THE LOW INSPIRATORY PRESSURE AND CIRCUIT DISCONNECT ALARM WERE OBSERVED IN THE DEVICE'S ERROR LOG. THE SERVICE TECHNICIAN DID A CROSS-CHECK WITH THE WAVEFORM, AND IT WAS CONFIRMED THAT FLOW, PRESSURE AND LEAK WERE RAPIDLY DECREASED. ANOTHER ERROR CODE, BLOWER MODEL DEV, WAS OBSERVED IN THE DEVICE'S ERROR LOG. THIS PARTICULAR ERROR CODE INDICATES A BLOWER LIMIT HAD OCCURRED. THE SERVICE TECHNICIAN PERFORMED A FLOW TEST, AND NO ABNORMALITIES WERE OBSERVED. BASED ON THE INFORMATION ABOV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25449428 ↗
• MalfunctionJun 9, 2026Circuit Failure

  A TRILOGY O2 DEVICE WAS RETURNED TO THE MANUFACTURER DUE TO A "VENTILATOR SERVICE REQUIRED" ALARM. NO PATIENT HARM OR INJURY WAS REPORTED. THE TRILOGY O2 DEVICE WAS EVALUATED BY THE MANUFACTURER. A CODE INDICATING A FAILURE OF THE OXYGEN BLENDING MODULE WAS RECORDED. IT WAS CONFIRMED THAT AN ABNORMALITY OF THE AIR SIDE FLOW SENSOR INSIDE THE OXYGEN BLENDER MODULE WAS DETECTED. THE BLENDER PCA WAS REPLACED TO ADDRESS THE ISSUE. THE DEVICE PASSED ALL FINAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25446350 ↗
• MalfunctionMay 13, 2026Circuit Failure; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION FROM A NURSE ALLEGING THAT A VENTILATOR SERVICE REQUIRED ALARM OCCURRED WHILE USING A TRILOGY O2 DEVICE. THE DEVICE WAS REPLACED WITH ANOTHER DEVICE AT THE CUSTOMER SITE. THERE WAS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS SPECIFIED BY THE PATIENT. THE TRILOGY O2 DEVICE WAS RETURNED TO THE MANUFACTURER SERVICE CENTER FOR EVALUATION, AND THE CUSTOMER¿S COMPLAINT WAS CONFIRMED. DURING THE EVALUATION IT WAS NOTED THAT AN ERROR CODE, RIPC COMMUNICATION TO OXYGEN BLENDING MODULE (OBM) FAILED, WAS OBSERVED ON THE DEVICE'S ERROR LOG. THE MANUFACTURER'S SERVICE TECHNICIAN FURTHER EVALUATED AND DETERMINED THE OXYGEN BLENDER PRINTED CIRCUIT ASSEMBLY AND INTERFACE PCA HAD CAUSED THE VENTILATOR SERVICE REQUIRED ALARM TO OCCUR ON THE DEVICE. IN CONCLUSION, THE DEVICE'S OXYGEN BLENDER PCA AND INTERFACE PCA WERE REPLACED TO ADDRESS THE ISSUE. THE ROOT CAUSE IS CONFIRMED AT THIS TIME. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, THE TRILOGY O2 PM1 KIT WAS REPLACED FOR PREVENTATIVE MAINTENANCE UNRELATED TO THE REPORTABLE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25163476 ↗
• MalfunctionMay 7, 2026Circuit Failure; Failure to Calibrate

  A TRILOGY 100 VENTILATOR DEVICE WAS RETURNED TO A SERVICE CENTER FOR SERVICE. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. DURING THE EVALUATION, THE SERVICE TECHNICIAN OBSERVED A VERIFY DIFFERENTIAL PRESSURE SENSOR CALIBRATION TEST FAILURE AND THE 200/O2 SENSOR PRINTED CIRCUIT ASSEMBLY (PCA) WAS REPLACED TO ADDRESS THE FAILURE. ADDITIONALLY, THE HANDLE AND FRONT ENCLOSURE WERE REPLACED DUE TO DAMAGE OBSERVED, THE FRONT PANEL/KEYPAD LED PCA WAS REPLACED DUE TO THE LEFT BUTTON RESPONDED AS PRESSING TWICE EVEN THOUGH PRESSING ONLY ONCE, AND THE BASE ENCLOSURE WAS REPLACED DUE TO THE SCREW FASTENING COUNT EXCEEDED THE PRESCRIBED VALUE. PERFORM A REPAIR TEST, CHECK ALARMS, AND CHECK BATTERY LIFE. RUNNING TESTS AND CLEANING WERE PERFORMED TO CONFIRM NORMAL OPERATION. SOFTWARE VERSION 14.2.05 HAS BEEN CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25115253 ↗
• MalfunctionMay 4, 2026Electrical /Electronic Property Problem; Device Sensing Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR SERVICE REQUIRED ALARM HAD OCCURRED WHILE PERFORMING THE OPERATIONAL CHECK DURING PREVENTATIVE MAINTENANCE ON A TRILOGY O2 DEVICE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. THE TRILOGY O2 DEVICE WAS RETURNED TO THE MANUFACTURER SERVICE CENTER FOR PREVENTATIVE MAINTENANCE WHEN THE VENTILATOR SERVICE REQUIRED ALARM SOUNDED ON THE DEVICE. DURING THE EVALUATION IT WAS NOTED THAT AN ERROR CODE, OXYGEN BLENDING MODULE (OBM) ACCURACY URGENCY SERVICE, ERROR CODE WAS OBSERVED ON THE DEVICE'S ERROR LOG. THE SERVICE TECHNICIAN FURTHER EVALUATED AND DETERMINED THE AIR FLOW SENSOR LOCATED ON THE OBM BLENDER PRINTED CIRCUIT ASSEMBLY (PCA) HAD CAUSED THE VENTILATOR SERVICE REQUIRED ALARM TO OCCUR ON THE DEVICE. IN CONCLUSION, THE OBM BLENDER PCA WAS REPLACED TO ADDRESS THE ISSUE. THE ROOT CAUSE IS CONFIRMED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25070804 ↗
• MalfunctionApr 30, 2026Circuit Failure; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED A REPORT THAT A TRILOGY O2 VENTILATOR WAS REPLACED DUE TO OCCURRENCE OF A "VENTILATOR SERVICE REQUIRED" ALARM. THERE WERE NO REPORTS OR ALLEGATIONS OF PATIENT HARM OR INJURY. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. DURING AN INITIAL OPERATIONAL CHECK, A ¿VENTILATOR SERVICE REQUIRED¿ ALARM WAS NOT DUPLICATED. DEVICE LOG FILES WERE SUCCESSFULLY RETRIEVED AND REVIEWED IN THEIR ENTIRETY. REVIEW OF THE LOGS CONFIRMED THE PRESENCE OF A ¿VENTILATOR SERVICE REQUIRED¿ ALARM ASSOCIATED WITH ERROR CODE ERR_OBM_AIR_FLOW_SENSOR_FAILED, INDICATING A FAILURE RELATED TO THE AIR-SIDE FLOW SENSOR WITHIN THE OXYGEN BLENDER MODULE. TO ADDRESS THE IDENTIFIED CONDITION, THE OXYGEN BLENDER PRINTED CIRCUIT ASSEMBLY (PCA), WHICH INCLUDES THE FLOW SENSOR, WAS REPLACED. IN ADDITION, THE TRILOGY O2 PM1 PREVENTIVE MAINTENANCE KIT WAS REPLACED AS PART OF SCHEDULE MAINTENANCE ACTIVITIES. FOLLOWING CORRECTIVE ACTIONS, THE ENGINEER PERFORMED POST-REPAIR VERIFICATION TESTING, INCLUDING ALARM TESTING, BATTERY PERFORMANCE CHECKS, FUNCTIONAL RUN-IN TESTING, AND DEVICE CLEANING. THE VENTILATOR PASSED ALL EVALUATIONS AND WAS CONFIRMED TO BE OPERATING WITHIN SPECIFICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25044148 ↗
• MalfunctionApr 27, 2026Circuit Failure; Electrical /Electronic Property Problem

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. 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 CUSTOMER'S COMPLAINT WAS NOT CONFIRMED. HOWEVER, A "SERVICE REQUIRED" ERROR CODE ERR_OBM_AIR_FLOW_SENSOR_FAILED WAS FOUND IN THE VENTILATOR'S DOWNLOADED EVENT LOG. THE TECHNICIAN RECOMMENDED REPLACING THE DEVICE'S OXYGEN BLENDER CIRCUIT BOARD TO ADDRESS THE ISSUE. THE ROOT CAUSE WAS CONFIRMED. ADDITIONALLY, THE SERVICE LIFE OF THE DEVICE WILL END ON 11/25/2026, THE DEVICE WILL BE SCRAPPED AFTER THE LEASE-UP PROCESSING. ALSO, THE EVALUATION OF THE DEVICE DATA IDENTIFIED UNRELATED ERROR CODES. THESE ERROR CODES ARE CONSISTENT WITH NORMAL DEVICE OPERATION AND EXPECTED USE CONDITIONS AND ARE NOT CONSIDERED REPORTABLE UNDER MEDICAL DEVICE REPORTING REQUIREMENTS. NO EVIDENCE WAS IDENTIFIED TO SUGGEST THAT THESE ERROR CODES CONTRIBUTED TO OR CAUSED THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25005816 ↗
• MalfunctionApr 27, 2026Electrical /Electronic Property Problem; Failure to Calibrate; Device Sensing Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR SERVICE REQUIRED ERROR CODE WAS FOUND DURING PREVENTATIVE MAINTENANCE ON A TRILOGY O2 DEVICE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. THE TRILOGY O2 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 ERROR CODE, OXYGEN BLENDING MODULE (OBM) ACCURACY URGENT SERVICE, WAS OBSERVED ON THE DEVICE'S ERROR LOG. THE SERVICE TECHNICIAN EVALUATED AND DETERMINED THE AIR FLOW SENSOR HAD CAUSED THE ERROR TO OCCUR ON THE DEVICE. THE SERVICE TECHNICIAN WENT TO TEST THE DEVICE, AND IT HAD FAILED THE NEGATIVE FLOW AND WRITE OBM SENSORS CALIBRATION TABLE. THE SERVICE TECHNICIAN FURTHER EVALUATED AND DETERMINED THE INTERFACE PRINTED CIRCUIT ASSEMBLY (PCA) HAD CAUSED THESE TWO TEST STEPS TO FAIL ON THE DEVICE. IN CONCLUSION, THE OXYGEN BLENDER PCA AND INTERFACE PCA WERE REPLACE SINCE IT IS EQUIPPED WITH THE AIR FLOW SENSOR TO ADDRESS THIS ISSUE. THE ROOT CAUSE IS CONFIRMED AT THIS TIME. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, THE TRILOGY O2 KIT WAS REPLACED FOR PREVENTATIVE MAINTENANCE UNRELATED TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24998253 ↗
• MalfunctionApr 24, 2026Circuit Failure; Electrical /Electronic Property Problem

  A TRILOGY O2 VENTILATOR JAPAN DEVICE WAS RETURNED TO THE MANUFACTURER FOR ROUTINE PREVENTATIVE MAINTENANCE. NO HARM OR INJURY WAS REPORTED, AND THE DEVICE WAS NOT IN PATIENT USE AT THE TIME OF THE EVENT. DURING EVALUATION AT THE MANUFACTURER'S SERVICE CENTER, AN ERR_OBM_AIR_FLOW_SENSOR_FAILED VENTILATOR SERVICE REQUIRED ERROR CODE WAS IDENTIFIED IN THE DOWNLOADED EVENT LOG. THE DEVICE'S OXYGEN BLENDER CIRCUIT BOARD WAS REPLACED TO ADDRESS THE ISSUE. A PERIODIC MAINTENANCE 1 PROCEDURE WAS ALSO PERFORMED, AND THE TRILOGY O2 PM1 KIT WAS REPLACED AS REQUIRED BY THE MAINTENANCE PROCEDURE TO PREVENT POTENTIAL FAILURE. THE TECHNICIAN COMPLETED REPAIR TEST, ALARM CHECK, BATTERY CHECK, RUN-IN TESTING, AND CLEANING. THE DEVICE WAS CONFIRMED TO OPERATE PROPERLY. THE SOFTWARE VERSION WAS VERIFIED AS 14.2.05.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24984909 ↗
• MalfunctionMar 10, 2026Power Problem

  THE MANUFACTURER RECEIVED INFORMATION FROM THE HOSPITAL ALLEGING THE POWER SOURCE SUDDENLY SWITCHED TO THE DETACHABLE BATTERY WHILE THE TRILOGY O2 DEVICE WAS ON AC POWER. THE CUSTOMER ALLEGED THAT AN AC POWER DISCONNECT ALARM HAD OCCURRED AT THE TIME OF THIS ISSUE. THE DEVICE WAS REPLACED WITH ANOTHER DEVICE. THERE WAS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS SPECIFIED BY THE PATIENT. THE TRILOGY O2 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 POWER SUPPLY PRINTED CIRCUIT ASSEMBLY (PCA) HAD CAUSED THE ISSUE TO OCCUR ON THE DEVICE. IN CONCLUSION, THE DEVICE'S POWER SUPPLY PCA WAS REPLACED TO ADDRESS THE ISSUE. THE ROOT CAUSE IS CONFIRMED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24560482 ↗
• MalfunctionFeb 24, 2026Circuit Failure; Use of Device Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR WAS ALARMING FOR A SERVICE REQUIRED ALARM CONDITION. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION THE CUSTOMER'S COMPLAINT WAS CONFIRMED. A SERVICE REQUIRED ALARM INDICATING THE COMMUNICATION TO THE OXYGEN BLENDING MODULE BOARD FAILED WAS OBSERVED. THE DEVICE'S OXYGEN BLENDING MODULE BOARD AND INTERFACE BOARD WERE REPLACED TO ADDRESS THE ISSUE. THE DEVICE WAS CLEANED AND TESTED AND PASSED ALL FINAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24433893 ↗
• MalfunctionFeb 4, 2026Circuit Failure; Electrical /Electronic Property Problem

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR PREVENTIVE MAINTENANCE. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, A "SERVICE REQUIRED" ALARM INDICATING AN AIR FLOW SENSOR FAILURE OCCURRED WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S OXYGEN BLENDING MODULE BOARD WAS REPLACED TO ADDRESS THE ISSUE. THE DEVICE WAS TESTED AND PASSED ALL FINAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24258752 ↗
• MalfunctionFeb 4, 2026No Display/Image

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A BLANK SCREEN OCCURRED ON A TRILOGY O2 DEVICE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. THE TRILOGY O2 DEVICE WAS RETURNED TO THE MANUFACTURER SERVICE CENTER FOR EVALUATION, AND THE CUSTOMER¿S COMPLAINT WAS NOT CONFIRMED. DURING THE EVALUATION IT WAS NOTED THAT THE SERVICE TECHNICIAN ALLEGED A TEMPORARILY LIGHTING FAILURE OF THE LIQUID CRYSTAL DISPLAY (LCD) HAD OCCURRED ON THE DEVICE. IN CONCLUSION, THE DEVICE'S LCD WAS REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, THE TRILOGY O2 PM LOT WAS REPLACED FOR PREVENTATIVE MAINTENANCE UNRELATED TO THE REPORTABLE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24258189 ↗
• MalfunctionFeb 3, 2026Circuit Failure; Electrical /Electronic Property Problem; Failure to Calibrate

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR SERVICE REQUIRED ERROR CODE WAS FOUND DURING PREVENTATIVE MAINTENANCE ON A TRILOGY O2 DEVICE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. THE TRILOGY O2 DEVICE WAS BEING EVALUATED AT THE MANUFACTURER SERVICE CENTER. DURING THE EVALUATION IT WAS NOTED THAT AN ERROR CODE, OXYGEN BLENDING MODULE (OBM) ACCURACY URGENCY SERVICE (E-0344), WAS OBSERVED ON THE DEVICE'S ERROR LOG. THE MANUFACTURER SERVICE TECHNICIAN FURTHER EVALUATED AND DETERMINED THE OXYGEN SENSOR HAD FAILED. THE MANUFACTURER SERVICE TECHNICIAN REPLACED THE OBM PRINTED CIRCUIT ASSEMBLY (PCA) SINCE IT INSTALLS THE OXYGEN SENSOR. THIS ADDRESSED THE REPORTABLE ISSUE. THE MANUFACTURER SERVICE TECHNICIAN TESTED THE DEVICE, AND IT FAILED ON THE ZERO FLOW VERIFY TEST STEP. THE MANUFACTURER SERVICE TECHNICIAN RE-EVALUATED THE DEVICE AND DETERMINED THE TEST STEP FAILED DUE TO THE SENSOR PCA. THE SENSOR PCA WAS REPLACED TO ADDRESS THIS REPORTABLE ISSUE. THE ROOT CAUSE IS CONFIRMED AT THIS TIME. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, THE TRILOGY O2 PM, CAPACITOR, BATTERY FAN EXHAUST FAN ASSEMBLY, STIRRING FAN, AND FORTY-THREE MICRON FILER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24248583 ↗
• MalfunctionJan 29, 2026Circuit Failure; Failure to Calibrate

  THE TRILOGY O2 VENTILATOR WAS RETURNED TO THE MANUFACTURER SERVICE CENTER FOR PREVENTATIVE MAINTENANCE. THE DEVICE WAS NOT REPORTED TO BE IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. DURING THE EVALUATION IT WAS NOTED THE DEVICE FAILED A TEST STEP DURING TESTING. IN CONCLUSION THE DEVICE OXYGEN BLENDER BOARD WAS REPLACED TO ADDRESS THE ISSUE. TH ROOT CAUSE WAS CONFIRMED. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, THE TRILOGYO2 PM1 KIT WAS REPLACED PER THE CUSTOMER'S REQUEST. THE TECHNICIAN PERFORMED REPAIR TEST, ALARM CHECK, BATTERY CHECK, RUN IN TESTS AND CLEANING THEN CONFIRMED THE UNIT OPERATED PROPERLY. CONFIRMED THE SOFTWARE VERSION IS 14.2.05.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24208379 ↗
• MalfunctionJan 20, 2026Circuit Failure; Device Sensing Problem

  THE TRILOGY O2 VENTILATOR WAS RETURNED TO THE MANUFACTURER SERVICE CENTER FOR PREVENTATIVE MAINTENANCE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. DURING THE EVALUATION OF THE DEVICE THE CUSTOMERS COMPLAINT WAS NOT CONFIRMED. PERIODIC MAINTENANCE 1 WAS PERFORMED AND AN ERROR CODE IN RELATION TO LOW FLOW (OBM_FLOW_SENSOR_FAILED) WAS RECORDED IN THE DEVICE EVENT LOG. IN CONCLUSION THE OXYGEN BLENDER SYSTEM BOARD WAS REPLACED TO ADDRESS THE ISSUE. THE ROOT CAUSE IS CONFIRMED AT THIS TIME. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, THE TECHNICIAN PERFORMED REPAIR TEST, ALARM CHECK, BATTERY CHECK, RUN IN TESTS, CLEANING THEN CONFIRMED THE UNIT OPERATED PROPERLY. THE SOFTWARE VERSION WAS CHECKED (VER.14.2.05).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24115698 ↗
• MalfunctionJan 14, 2026Circuit Failure; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED A COMPLAINT REPORTING ACTIVATION OF A ¿VENTILATOR SERVICE REQUIRED¿ ALARM ON A TRILOGY O2 VENTILATOR. THE DEVICE WAS RETRIEVED FOR EVALUATION. THERE WERE NO REPORTS OR ALLEGATIONS OF PATIENT HARM OR INJURY ASSOCIATED WITH THIS EVENT. THE VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR INVESTIGATION. REVIEW OF THE DEVICE LOG FILES IDENTIFIED A ¿VENTILATOR SERVICE REQUIRED¿ ERROR (ERR_OBM_AIR_FLOW_SENSOR_FAILED), INDICATING A FAILURE OF THE OXYGEN BLENDING MODULE (OBM). TO ADDRESS THIS CONDITION, THE OXYGEN BLENDER PRINTED CIRCUIT ASSEMBLY (PCA) WAS REPLACED. SEPARATELY, AND UNRELATED TO THE REPORTED MALFUNCTION, THE TRILOGY O2 PM1 KIT WAS REPLACED AS PART OF ROUTINE PREVENTIVE MAINTENANCE. FOLLOWING COMPLETION OF SERVICE ACTIVITIES, THE DEVICE SUCCESSFULLY PASSED ALL REQUIRED FUNCTIONAL AND PERFORMANCE TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24066864 ↗
• MalfunctionJan 12, 2026Circuit Failure

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR ROUTINE PREVENTATIVE 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 "VENTILATOR SERVICE REQUIRED" CONCERNING THE SYSTEM OBM WAS FOUND. THE OBM BOARD NEEDS TO BE REPLACED TO ADDRESS THE ISSUE AS CALIBRATION DOES NOT FIX THE PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24033030 ↗
• MalfunctionJan 9, 2026No Display/Image; Electrical /Electronic Property Problem

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR PREVENTIVE MAINTENANCE. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION AT THE MANUFACTURER'S SERVICE CENTER THE DEVICE'S LCD SCREEN WAS WHITE. THE DEVICE'S LCD SCREEN WAS REPLACED TO ADDRESS THE ISSUE. THE DEVICE WAS CLEANED AND TESTED AND PASSED ALL FINAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24025321 ↗
• MalfunctionJan 8, 2026Circuit Failure; Failure to Calibrate

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR WAS ALARMING FOR A SERVICE REQUIRED ALARM CONDITION. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION THE DEVICE'S OXYGEN BLENDING MODULE BOARD NEEDED REPLACED DUE TO AN ISSUE WITH THE OXYGEN BLENDING MODULE O2 SENSOR WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THIS ISSUE WAS NOT REPORTED AS THE O2 SENSOR MONITORS THE OXYGEN LEVEL AND DOES NOT AFFECT THERAPY. ADDITIONAL TESTING WAS PERFORMED AND THE DEVICE FAILED POSITIVE AND NEGATIVE FLOW VERIFICATION TEST STEPS. THE DEVICE'S SENSOR BOARD NEEDS TO BE REPLACED TO ADDRESS THE ISSUE. THE BLOWER MOTOR NEEDS REPLACED TO ADDRESS NOISE AND A LIFE RELATED SMELL. THE KEYPAD NEEDS REPLACED DUE TO THE SURFACE PEELING. THE CUSTOMER CANCELLED THE REPAIR AND THE DEVICE WAS RETURNED UNREPAIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24004301 ↗
• MalfunctionJan 8, 2026Circuit Failure; Failure to Calibrate

  THE TRILOGY O2 VENTILATOR WAS RETURNED TO THE MANUFACTURER SERVICE CENTER FOR PREVENTATIVE MAINTENANCE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. DURING THE EVALUATION IT WAS NOTED THE TRILOGY O2 VENTILATOR FAILED TEST STEPS DURING TESTING. IN CONCLUSION THE DEVICES INTERFACE BOARD AND OXYGEN BLENDER BOARD WAS REPLACED TO ADDRESS THE ISSUES. THE ROOT CAUSE WAS CONFIRMED. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, COMPONENTS WERE ONLY REPLACED AS A PREVENTATIVE MEASURE UNRELATED TO THE REPORTED TEST FAILURES. THE TECHNICIAN PERFORMED REPAIR TEST, ALARM CHECK, BATTERY CHECK, RUN IN TESTS, CLEANING AND CONFIRMED THE UNIT OPERATED PROPERLY. THE SOFTWARE VERSION WAS CHECKED (.14.2.05). THE DETACHABLE BATTERY WILL BE REPLACED WHEN AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24001458 ↗
• MalfunctionJan 6, 2026Circuit Failure; Electrical /Electronic Property Problem; Failure to Calibrate

  THE MANUFACTURER RECEIVED A REPORT THAT A TRILOGY O2 VENTILATOR WAS RETURNED FOR ROUTINE PREVENTIVE MAINTENANCE. THERE WERE NO REPORTS OR ALLEGATIONS OF PATIENT HARM OR INJURY. THE VENTILATOR WAS EVALUATED AT A MANUFACTURER¿S SERVICE CENTER. THE UNIT FAILED THE O2 SENSOR CALIBRATION TEST. AS A RESULT, THE REPLACEMENT OF THE OXYGEN BLENDER PRINTED CIRCUIT ASSEMBLY (PCA) WAS NECESSARY. ALTHOUGH THE UNIT HAS EXCEEDED ITS USEFUL LIFE EXPECTANCY, THE FOLLOWING PARTS DESIGNATED BY THE CUSTOMER WERE REPLACED AS PER THEIR REQUEST: TRILOGY O2 PM1 KIT. THE CUSTOMER DECLINED TO HAVE THE BLOWER REPLACED EVEN THOUGH IT WAS RECOMMENDED. THE MANUFACTURER¿S SERVICE TECHNICIAN COMPLETED FINAL AND RUN-IN TESTING, INCLUDING BATTERY AND VALVE CHECKS, AND PERFORMED CLEANING. THE DEVICE WAS CONFIRMED TO BE OPERATING PROPERLY. THE OXYGEN BLENDING MODULE PCA WAS RETURNED TO THE MANUFACTURER'S PRODUCT INVESTIGATION LAB DUE TO THE FAILURE OF THE TEST DURING SERVICE. THE COMPONENT HAD ALREADY UNDERGONE A COMPREHENSIVE EVALUATION AT THE SERVICE CENTER PRIOR TO ARRIVING AT THE PRODUCT INVESTIGATION LAB. THERE WAS NO PATIENT HARM ASSOCIATED WITH THIS COMPONENT; THEREFORE, NO FURTHER INVESTIGATION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23981045 ↗
• MalfunctionJan 6, 2026Circuit Failure; Electrical /Electronic Property Problem; Failure to Calibrate

  THE MANUFACTURER RECEIVED A REPORT THAT A TRILOGY O2 VENTILATOR WAS RETURNED FOR ROUTINE PREVENTIVE MAINTENANCE. THERE WERE NO REPORTS OR ALLEGATIONS OF PATIENT HARM OR INJURY. THE VENTILATOR WAS EVALUATED AT A MANUFACTURER¿S SERVICE CENTER. THE UNIT FAILED THE O2 SENSOR CALIBRATION TEST. AS A RESULT, THE REPLACEMENT OF THE OXYGEN BLENDER PRINTED CIRCUIT ASSEMBLY (PCA) WAS NECESSARY. ALTHOUGH THE UNIT HAS EXCEEDED ITS USEFUL LIFE EXPECTANCY, THE FOLLOWING PARTS DESIGNATED BY THE CUSTOMER WERE REPLACED AS PER THEIR REQUEST: TRILOGY O2 PM1 KIT. THE CUSTOMER DECLINED TO HAVE THE BLOWER REPLACED EVEN THOUGH IT WAS RECOMMENDED. THE MANUFACTURER¿S SERVICE TECHNICIAN COMPLETED FINAL AND RUN-IN TESTING, INCLUDING BATTERY AND VALVE CHECKS, AND PERFORMED CLEANING. THE DEVICE WAS CONFIRMED TO BE OPERATING PROPERLY. THE OXYGEN BLENDING MODULE PCA WAS RETURNED TO THE MANUFACTURER'S PRODUCT INVESTIGATION LAB DUE TO THE FAILURE OF THE TEST DURING SERVICE. THE COMPONENT HAD ALREADY UNDERGONE A COMPREHENSIVE EVALUATION AT THE SERVICE CENTER PRIOR TO ARRIVING AT THE PRODUCT INVESTIGATION LAB. THERE WAS NO PATIENT HARM ASSOCIATED WITH THIS COMPONENT; THEREFORE, NO FURTHER INVESTIGATION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23977158 ↗
• MalfunctionJan 5, 2026Failure to Calibrate

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE ZERO FLOW VERIFY AND NEGATIVE FLOW VERIFY TEST STEPS HAD FAILED ON A TRILOGY O2 DEVICE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. THE TRILOGY O2 DEVICE WAS EVALUATED AT THE MANUFACTURER SERVICE CENTER FOR THIS ISSUE. DURING THE EVALUATION IT WAS NOTED THAT THE DEVICES FLOW SENSOR HAD CAUSED THE ZERO FLOW VERIFY AND NEGATIVE FLOW VERIFY TEST STEPS TO FAIL ON THE DEVICE. IN CONCLUSION, THE MANUFACTURE SERVICE TECHNICIAN PERFORMED THE REPAIR TEST WHICH RE-CALIBRATED THE FLOW SENSOR TO ADDRESS THE ISSUE. THE ROOT CAUSE IS CONFIRMED AT THIS TIME. THERE WAS NO PART(S) REPLACED TO ADDRESS THIS ISSUE. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, THE TRILOGY O2 PM KIT WAS REPLACED FOR PREVENTATIVE MAINTENANCE UNRELATED TO THE REPORTABLE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23966976 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K093905. One submission often covers many models, so check the product and lot details in each record.

• Z-1065-2016 · Jan 18, 2016 · Terminated
  Trilogy 100, Trilogy 200, Trilogy O2, Trilogy 202, Trilogy EC, Garbin, Garbin Plus Trilogy 100, Trilogy 200, Garbin, Garbin plus provides continuous or intermittent ventilatory su
• Z-1143-2014 · Feb 11, 2014 · Terminated
  Trilogy Ventilators The Respironics Trilogy 100 system provides continuous or intermittent ventilator support for the care of individuals who require mechanical ventilation. Trilog
• Z-2024-2012 · Apr 27, 2012 · Terminated
  Respironics Trilogy 100, 200, and 202 Ventilators The Respironics Trilogy systems provides continuous or intermittent ventilatory support for the care of individuals who require m