Trilogy 100 Trilogy 100 Ventilator, w/ Bluetooth, JapanRecalls & reported problems

Summary

The FDA's MAUDE database contains 154 adverse event reports that list this exact device (DI 00606959052345), received between Oct 5, 2020 and Sep 28, 2026 — classified as 1 death, 3 injuries, 150 malfunctions.

The most frequently reported specific device problem is “Failure to Calibrate” (47 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 154 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Circuit Failure; Failure to Calibrate

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916611 ↗
• MalfunctionSep 24, 2026Circuit Failure; Electrical /Electronic Property Problem

  A Trilogy 100 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 the device alarmed for an internal battery depleted alarm condition. The device's power management board 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 50884111 ↗
• MalfunctionJun 26, 2026Mechanical Problem; Calibration Problem

  A TRILOGY 100 VENTILATOR DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SCHEDULED MAINTENANCE. THERE WAS NO ALLEGATION OF PATIENT HARM. THE DEVICE WAS NOT REPORTED TO BE IN PATIENT USE. DURING THE EVALUATION, THE DEVICE FAILED THE LOW FLOW O2 TEST. THE ACTIVE EXHALATION CONTROL MODULE WAS REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, THE CAPACITOR, BASE ENCLOSURE, BATTERY FAN, EXHAUST FAN ASSEMBLY, STIRRING FAN, 43-MICRON FILTER, AND POLLEN FILTER NEEDED TO BE REPLACED. PERFORMED REPAIR TEST, ALARM CHECK, BATTERY CHECK, RUN-IN TESTS, AND CLEANING, THEN CONFIRMED THE UNIT OPERATED PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25636197 ↗
• MalfunctionJun 17, 2026Calibration Problem

  THE MANUFACTURER RECEIVED INFORMATION THAT A TRILOGY 100 VENTILATOR DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO ALLEGATION OF HARM OR INJURY REPORTED. THE DEVICE WAS NOT REPORTED TO BE IN PATIENT USE. DURING THE EVALUATION, THE SERVICE TECHNICIAN OBSERVED A TEST LOW FLOW O2 FAILURE. NO DOCUMENTATION OF A REPLACED COMPONENT TO ADDRESS THE ISSUE. ADDITIONALLY, THE INTERNAL BATTERY, CAPACITOR, BATTERY FAN, EXHAUST FAN ASSEMBLY, STIRRING FAN, 43 MICRON FILTER, AND POLLEN FILTER WERE REPLACED TO PREVENT FAILURE. THE DETACHABLE BATTERY PACK AND INTERNAL BATTERY WERE NOT REPLACED DUE TO A LONG-TERM DELAY IN THE ARRIVAL OF REPLACEMENT PARTS BUT WILL BE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25537686 ↗
• MalfunctionMay 28, 2026Circuit Failure; Obstruction of Flow; Failure to Calibrate

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THAT NO PRESSURE APPEARED TO BE DELIVERED BY A TRILOGY 100 VENTILATOR, JAPAN - BT DEVICE AND THAT THE PATIENT EXPERIENCED DISCOMFORT. THE DEVICE WAS OPERATING IN AC MODE WITH A SET VENTILATION VOLUME OF 440 ML. IT WAS REPORTED THAT THE PEAK INSPIRATORY PRESSURE (PIP), NORMALLY GREATER THAN 20 HPA, HAD DECREASED TO APPROXIMATELY 10 HPA. THE DEVICE WAS REPLACED WITH THE SAME MODEL IN THE PATIENT'S HOME, AFTER WHICH THE PIP RETURNED TO GREATER THAN 20 HPA. IT WAS ADDITIONALLY REPORTED THAT WHEN THE ORIGINAL DEVICE WAS PLACED BACK INTO USE, THE PIP SIMILARLY RETURNED TO GREATER THAN 20 HPA. THE REPORTED ADVERSE EVENT OF PATIENT DISCOMFORT WAS ASSESSED AS A NON-SERIOUS INJURY WITH HARM SEVERITY 1. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S SERVICE CENTER FOR EVALUATION. DURING OPERATIONAL TESTING, THE REPORTED ISSUE COULD NOT BE REPRODUCED. INTERIOR INSPECTION IDENTIFIED WHITE PARTICULATE MATTER ADHERING TO THE AIR DELIVERY PATHWAY AND A CLOGGED 43-MICRON FILTER. INVESTIGATION DETERMINED THAT CLOGGING OF THE 43-MICRON FILTER LIKELY PREVENTED THE EXHALATION VALVE FROM FULLY CLOSING, THEREBY PREVENTING PRESSURE FROM INCREASING APPROPRIATEL

  Patient problems: Discomfort

  MAUDE report 25315341 ↗
• MalfunctionMay 26, 2026Circuit Failure; Electrical /Electronic Property Problem; Mechanical Problem

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR ROUTINE PREVENTATIVE MAINTENANCE. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION, AND THE DEVICE WAS NOT IN PATIENT USE. THE TRILOGY 100 VENTILATOR, JAPAN - BT DEVICE WAS EVALUATED AT THE MANUFACTURER, AND A VENTILATOR INOPERATIVE ERROR CODE ERR_DSP_MOTOR_FAILURE WAS DISCOVERED IN THE DEVICE'S EVENT LOG. THE DEVICE'S BLOWER MOTOR ASSEMBLY AND SYSTEM BOARD WERE REPLACED TO ADDRESS THE ISSUE. IN CONJUNCTION WITH REPLACEMENT OF THE BLOWER MOTOR ASSEMBLY, THE STIRRING FAN FOAM WAS ALSO REPLACED. FOLLOWING REPAIR, THE TECHNICIAN PERFORMED REPAIR TESTING, ALARM CHECK, BATTERY CHECK, RUN-IN TESTING, AND CLEANING. THE DEVICE WAS CONFIRMED TO BE OPERATING PROPERLY. SOFTWARE VERSION 14.2.05 WAS VERIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25291949 ↗
• MalfunctionMay 21, 2026Device Alarm System; Circuit Failure; Failure to Calibrate

  THE MANUFACTURER RECEIVED A REPORT THAT A TRILOGY 100 VENTILATOR WAS RETURNED FOR PREVENTIVE MAINTENANCE. NO PATIENT HARM OR INJURY WAS REPORTED. THE DEVICE WAS EVALUATED AT THE MANUFACTURER'S SERVICE CENTER. DURING FUNCTIONAL TESTING, THE DEVICE FAILED THE NURSE CALL ON TEST. TO CORRECT THE ISSUE, THE INTERFACE PRINTED CIRCUIT ASSEMBLY (PCA) WAS REPLACED. AS PART OF PREVENTIVE MAINTENANCE, THE POLLEN FILTER, EXHAUST FAN ASSEMBLY, AND 43-MICRON FILTER WERE REPLACED IN ACCORDANCE WITH THE MAINTENANCE PROCEDURE TO PREVENT FAILURE. THE TECHNICIAN SUBSEQUENTLY PERFORMED FINAL FUNCTIONAL TESTING, BATTERY TESTING, VALVE CHECKS, RUN-IN TESTING, AND CLEANING PROCEDURES. THE DEVICE WAS CONFIRMED TO BE OPERATING PROPERLY FOLLOWING SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25242166 ↗
• MalfunctionMay 19, 2026Electrical /Electronic Property Problem; Unexpected Shutdown

  THE MANUFACTURER RECEIVED INFORMATION FROM A DISTRIBUTOR WHO HAD RECEIVED A CALL FROM THE PATIENT'S FAMILY ALLEGING THE PATIENT EXPERIENCED THE TRILOGY 100 DEVICE HAD SUDDENLY STOPPED OPERATING AND AN ALARM BEEP SOUND OCCURRED AND DID NOT STOP BEEPING. THE DETAILS WERE ALLEGEDLY CONFIRMED AS THE TRILOGY 100 DEVICE HAD STOPPED AGAIN AFTER TURNING THE POWER ON AND INSERTING THE AC CORD. HOWEVER, THE OPERATION RESTARTED WITH BATTERY DRIVEN. THE DEVICE WAS REPLACED WITH ANOTHER DEVICE. THE DISTRIBUTOR'S REPRESENTATIVE INSERTED THE AC CORD AND CHECKED THE ISSUE BUT WAS NOT ABLE TO REPRODUCE IT ON THE DEVICE. THERE WAS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS SPECIFIED BY THE PATIENT. PHILIPS IS CURRENTLY INVESTIGATING THIS COMPLAINT. THE DEVICE HAS BEEN RECEIVED BY THE MANUFACTURER AND IS CURRENTLY AWAITING EVALUATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED AS DUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25218860 ↗
• MalfunctionMay 11, 2026Mechanical Problem

  A VENTILATOR WAS RETURNED TO A MANUFACTURER'S SERVICE CENTER FOR PREVENTIVE MAINTENANCE. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION A FAILURE OF THE ACTIVE EXHALATION CONTROL MODULE TO CLOSE WAS OBSERVED. THE DEVICE'S ACTIVE EXHALATION CONTROL MODULE 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 25137707 ↗
• MalfunctionMay 7, 2026Battery Problem

  A TRILOGY 100 VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR PREVENTATIVE MAINTENANCE SERVICE. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. DURING EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, AN 'INTERNAL BATTERY DEPLETED' ERROR CODE WAS FOUND IN THE DEVICE'S ERROR LOG. THE SERVICE TECHNICIAN STATES THAT THE INTERNAL BATTERY HAD A CHARGE AMOUNT OF 100%. THE POWER MANAGEMENT PRINTED CIRCUIT ASSEMBLY (PCA) BOARD WAS REPLACED TO RESOLVE THE ISSUE. ADDITIONALLY, THE POLLEN FILTER WAS REPLACED FOR MAINTENANCE. FINAL TESTING, ALARM TEST, BATTERY CHECK, RUN IN TESTING, AND CLEANING WERE PERFORMED. THE UNIT OPERATED PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25113448 ↗
• MalfunctionMay 7, 2026Mechanical Problem; Failure to Calibrate

  A TRILOGY 100 VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR PREVENTATIVE MAINTENANCE SERVICE. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. DURING EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE DEVICE FAILED A REPAIR TEST STEP RELATING TO 'ACTIVE EXHALATION PURGE VALVE CLOSED' AND ACTIVE EXHALATION VALVE OPENED.' THE SERVICE TECHNICIAN STATES THAT THE ACTIVE EXHALATION CONTROL MODULE VALVE WAS REPLACED TO RESOLVE THE ISSUE. ADDITIONALLY, THE POLLEN FILTER, EXHAUST FAN ASSEMBLY, AND 43 MICRON FILTER WERE REPLACED FOR MAINTENANCE. FINAL TESTING, ALARM TEST, BATTERY TEST, RUN IN TESTING, AND CLEANING WERE PERFORMED. THE UNIT OPERATED PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25113443 ↗
• MalfunctionApr 27, 2026Mechanical Problem; Failure to Calibrate

  A TRILOGY 100 VENTILATOR JAPAN BT DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR ROUTINE PREVENTATIVE MAINTENANCE. NO PATIENT HARM WAS REPORTED, AND THE DEVICE WAS NOT IN PATIENT USE AT THE TIME OF THE EVENT. DURING EVALUATION AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE FAILED THE ACTIVE EXHALATION PROPORT VALVE OPENED TEST STEP. THE DEVICE'S ACTIVE EXHALATION CONTROL MODULE AECM WAS REPLACED TO ADDRESS THE ISSUE. SEPARATELY, THE DEVICE FAILED THE NURSE CALL ON TEST STEP. THE DEVICE'S INTERFACE BOARD WAS REPLACED TO CORRECT THIS ISSUE. A PERIODIC MAINTENANCE 1 PROCEDURE WAS PERFORMED, AND THE DEVICE'S POLLEN FILTER 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 25009416 ↗
• MalfunctionApr 20, 2026Circuit Failure; Electrical /Electronic Property Problem; Mechanical Jam

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A PATIENT EXPERIENCED VENTILATOR INOPERATIVE ALARM OCCURRED WHILE USING A TRILOGY 100 DEVICE. 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 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 ERROR CODS, DSP MOTOR FAILURE AND DSP MAXIMUM HOST REBOOTS, WERE OBSERVED IN THE DEVICE'S ERROR LOG. THE SERVICE TECHNICIAN FURTHER EVALUATED AND DETERMINED THE BLADES WERE LOCKED CAUSED BY THE MOTOR BLOWER ASSEMBLY HAD CAUSED THE MOTOR FAILURE AND THE SYSTEM PRINTED CIRCUIT ASSEMBLY (PCA) CAUSED THE MAXIMUM HOST REBOOTS TO OCCUR ON THE DEVICE. IN CONCLUSION, THE MOTOR ASSEMBLY AND SYSTEM PCA WERE REPLACED TO ADDRESS THE ISSUE. THE ROOT CAUSE IS CONFIRMED AT THIS TIME. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, THE SPEAKER WAS REPLACED TO ADDRESS FOR ANOTHER ERROR CODE, SPEAKER 2 FAILURE, WHICH WAS OBSERVED ON THE DEVICE'S ERROR LOG. THIS WAS UNRELATED TO THE REPORTABLE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24926860 ↗
• MalfunctionApr 17, 2026Mechanical Problem; Failure to Calibrate

  THE MANUFACTURER RECEIVED INFORMATION THAT A TRILOGY 100 VENTILATOR WAS RETURNED FOR SERVICE. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. THE DEVICE WAS EVALUATED AT A MANUFACTURER'S SERVICE CENTER. DURING TESTING, THE UNIT FAILED THE ACTIVE EXHALATION PROPORTIONAL VALVE TEST. FURTHER INVESTIGATION DETERMINED THAT THE ACTIVE EXHALATION CONTROL MODULE (AECM) REQUIRED REPLACEMENT TO CORRECT THE ISSUE. ADDITIONALLY, UNRELATED TO THE REPORTABLE MALFUNCTION, THE UNIT FAILED THE NURSE CALL ON TEST STEP. THERE WAS NO INDICATION THAT THERE WAS AN ISSUE WITH THE NURSE CALL CONNECTOR. THE INTERFACE PRINTED CIRCUIT ASSEMBLY (PCA) WAS REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, THE POLLEN FILTER WAS REPLACED AS PART OF PREVENTIVE MAINTENANCE. SINCE SCRATCHES WERE CONFIRMED, THE FRONT ENCLOSURE OVERLAY WAS REPLACED. FOLLOWING REPAIR, THE DEVICE SUCCESSFULLY PASSED ALL REQUIRED VERIFICATION PROCEDURES, INCLUDING REPAIR VERIFICATION TESTING, ALARM TESTING, BATTERY PERFORMANCE TESTING, AND RUN-IN TESTING. THE DEVICE WAS ALSO CLEANED IN ACCORDANCE WITH STANDARD PROCEDURES. THE DEVICE WAS CONFIRMED TO BE OPERATING WITHIN SPECIFICATION AND WAS RETURNED TO SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24910279 ↗
• MalfunctionApr 16, 2026Circuit Failure; Failure to Calibrate

  A TRILOGY 100 VENTILATOR, JAPAN - BT WAS RETURNED TO THE MANUFACTURER FOR ROUTINE PREVENTATIVE MAINTENANCE. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION, AND THE DEVICE WAS NOT REPORTED TO BE IN PATIENT USE. DURING THE REPAIR TEST PERFORMED AT THE MANUFACTURER'S SERVICE CENTER, THE DEVICE FAILED THE INTERNAL LI-ION BATTERY POWER SOURCE TEST STEP. THE DEVICE'S POWER MANAGEMENT BOARD WAS REPLACED TO ADDRESS THIS ISSUE. ADDITIONALLY, THE BASE ENCLOSURE WITH TAPPING SCREWS WAS REPLACED BECAUSE THE LIMIT OF TWO SCREW REINSERTIONS INTO THE BASE ENCLOSURE HAD BEEN EXCEEDED. A PERIODIC MAINTENANCE 2 PROCEDURE WAS COMPLETED. AS PART OF THIS MAINTENANCE, THE POLLEN FILTER, STIRRING FAN, CAPACITOR, BATTERY FAN, EXHAUST FAN ASSEMBLY, AND 43-MICRON FILTER WERE REPLACED IN ACCORDANCE WITH THE MAINTENANCE REQUIREMENTS TO PREVENT POTENTIAL FAILURE. THE SERVICE TECHNICIAN PERFORMED REPAIR TEST, ALARM TESTING, BATTERY TESTING, RUN-IN TESTING, AND CLEANING. THE DEVICE WAS CONFIRMED TO OPERATE PROPERLY FOLLOWING THESE PROCEDURES. THE SOFTWARE VERSION WAS VERIFIED AS 14.2.05. THE DETACHABLE BATTERY PACK AND INTERNAL BATTERY WERE NOT REPLACED DUE TO A LONG-TERM DELAY IN THE AVAILABILITY OF REPLACEMENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24900108 ↗
• MalfunctionApr 6, 2026Mechanical Problem; Failure to Calibrate

  THE MANUFACTURER RECEIVED INFORMATION THAT A TRILOGY 100 VENTILATOR WAS RETURNED FOR SERVICE. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. THE DEVICE WAS EVALUATED AT A MANUFACTURER'S SERVICE CENTER. DURING TESTING, THE UNIT FAILED THE ACTIVE EXHALATION FUNCTION TEST. FURTHER INVESTIGATION DETERMINED THAT THE ACTIVE EXHALATION CONTROL MODULE (AECM) REQUIRED REPLACEMENT TO CORRECT THE ISSUE. IN ADDITION, UNRELATED TO THE REPORTABLE MALFUNCTION, THE POLLEN FILTER, EXHAUST FAN ASSEMBLY, AND 43-MICRON FILTER WERE REPLACED AS PART OF PREVENTIVE MAINTENANCE. SINCE SCRATCHES WERE CONFIRMED, THE FRONT ENCLOSURE WAS REPLACED. FOLLOWING REPLACEMENT OF THE AECM, THE DEVICE SUCCESSFULLY PASSED ALL REQUIRED VERIFICATION PROCEDURES, INCLUDING REPAIR VERIFICATION TESTING, ALARM TESTING, BATTERY PERFORMANCE TESTING, AND RUN-IN TESTING. THE DEVICE WAS ALSO CLEANED IN ACCORDANCE WITH STANDARD PROCEDURES. THE DEVICE WAS CONFIRMED TO BE OPERATING WITHIN SPECIFICATION AND WAS RETURNED TO SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24790552 ↗
• InjuryMar 31, 2026Electrical /Electronic Property Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION THAT AN ALARM OCCURRED ON A TRILOGY 100 VENTILATOR WHILE IN USE WITH A PATIENT. THE PATIENT'S FAMILY REPORTED THE INSPIRATORY PRESSURE LIMIT ALARM WOULDN'T STOP ALARMING AND THE VENTILATION RATE WAS BELOW THE SET LEVEL. THE PHILIPS SALES REPRESENTATIVE ARRIVED AT THE PATIENT'S HOME AND CONFIRMED THAT IT WAS OBSERVED THAT THE VALUE EXCEEDS THE UPPER LIMIT OF THE INSPIRATORY PRESSURE DURING FORCED VENTILATION. ALTHOUGH IT WAS ONLY A SHORT CHECK, THE VENTILATION VOLUME REPORTED BY THE FAMILY AS ¿BEING BELOW THE SET VALUE¿ WAS NOT OBSERVED WHEN CONNECTED TO THE TEST LUNG. THE PHILIPS SALES REPRESENTATIVE REPLACED THE DEVICE WITH THE SAME MODEL. THE PATIENT HAD A DROP OF OXYGEN SATURATION FROM AROUND 98% TO 83% DURING THE EVENT. THE PATIENT RECOVERED IMMEDIATELY ON (B)(6) 2026 BY PERFORMING MANUAL VENTILATION WITH AN AMBU BAG. BASED ON INFORMATION AVAILABLE AT THE TIME OF THIS REVIEW, THERE IS SUFFICIENT EVIDENCE TO PRONOUNCE THIS EVENT AS SERIOUS INJURY. DEVICE EVALUATIONS AND A LOG ANALYSIS ARE NEEDED TO FURTHER DISPOSITION CAUSE/CONTRIBUTION OF THE REPORTED ADVERSE EVENT. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. AT

  Patient problems: Hypoxia

  MAUDE report 24746130 ↗
• MalfunctionMar 10, 2026Circuit Failure; Battery Problem

  A TRILOGY 100 DEVICE WAS RETURNED TO THE MANUFACTURER FOR PREVENTATIVE MAINTENANCE. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. DURING EVALUATION OF THE DEVICE AT THE MANUFACTURER SERVICE CENTER, AN 'INTERNAL BATTERY NOT CHARGING' ERROR CODE WAS FOUND IN THE DEVICE'S ERROR LOG. THE SERVICE TECHNICIAN STATES THAT THE POWER MANAGEMENT PRINTED CIRCUIT ASSEMBLY (PCA) BOARD WAS REPLACED TO RESOLVE THE ERROR. ADDITIONALLY, THE POLLEN FILTER, EXHAUST FAN ASSEMBLY, 43 MICRON FILTER, MOTOR BLOWER ASSEMBLY, STIRRING FAN FOAM WERE REPLACED FOR MAINTENANCE. REPAIR TESTING, ALARM CHECK, BATTERY CHECK, RUN IN TESTING, AND CLEANING WERE PERFORMED. THE UNIT OPERATED PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24561660 ↗
• MalfunctionFeb 24, 2026Failure to Calibrate; Device Sensing Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE ACTIVE EXHALATION VERIFICATION TEST STEPS HAD FAILED DURING PREVENTATIVE MAINTENANCE ON A TRILOGY 100 BT DEVICE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. DURING THE EVALUATION IT WAS NOTED THAT THE ACTIVE EXHALATION CONTROL MODULE (AECM) HAD CAUSED THE ACTIVE EXHALATION VERIFICATION TEST STEPS TO FAIL ON THE 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 POLLEN FILTER, EXHAUST FAN ASSEMBLY, AND FORTY-THREE (43) MICRON FILTER WERE REPLACED FOR PREVENTATIVE MAINTENANCE UNRELATED TO THE REPORTABLE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24433690 ↗
• MalfunctionFeb 13, 2026Mechanical Problem; Failure to Calibrate

  A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR PREVENTIVE MAINTENANCE. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION, THE DEVICE FAILED A TEST STEP INDICATING A CIRCUIT LEAK FAILURE. THE DEVICE'S ACTIVE EXHALATION CONTROL MODULE WAS REPLACED TO ADDRESS THE ISSUE. THERE WAS NO TEST SHEET AVAILABLE FOR REVIEW. ADDITIONALLY, NOT RELATED TO THE REPORTABLE ISSUE, THE DEVICE'S BLOWER MOTOR WAS FOUND TO BE NOISY AND WAS REPLACED TO ADDRESS THE ISSUE. THE DEVICE'S STIRRING FAN FOAM, POLLEN FILTER AND MICRON FILTER WERE REPLACED PREVENTATIVELY. THE DEVICE WAS CLEANED AND TESTED AND PASSED ALL FINAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24333582 ↗
• MalfunctionFeb 13, 2026Circuit Failure; Failure to Calibrate

  THE MANUFACTURER RECEIVED A REPORT INDICATING THAT DURING A TEST RUN CONDUCTED IN THE SALES OFFICE, A TRILOGY 100 VENTILATOR DISPLAYED A LOW LEAK VALUE, RESULTING IN ACTIVATION OF A "LOW CIRCUIT LEAK" ALARM. NO HARM OR INJURY WAS REPORTED IN ASSOCIATION WITH THIS EVENT. THE DEVICE WAS RETURNED TO THE MANUFACTURER¿S SERVICE CENTER FOR EVALUATION. DURING OPERATIONAL TESTING, THE "LOW CIRCUIT LEAK" ALARM WAS SUCCESSFULLY REPRODUCED. INVESTIGATION DETERMINED THAT THE ALARM CONDITION WAS CAUSED BY A MALFUNCTION OF THE FLOW SENSOR. TO CORRECT THE ISSUE, THE FLOW SENSOR PRINTED CIRCUIT ASSEMBLY (PCA) WAS REPLACED. FOLLOWING THE REPAIR, THE SERVICE TECHNICIAN PERFORMED FUNCTIONAL VERIFICATION TESTING, INCLUDING A REPAIR TEST, ALARM CHECK, BATTERY CHECK, RUN-IN TESTING, AND CLEANING. THE DEVICE WAS CONFIRMED TO BE OPERATING PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24331464 ↗
• MalfunctionFeb 12, 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 A SERVICE REQUIRED ALARM CONDITION INDICATING THE INTERNAL BATTERY WAS DEPLETED WAS OBSERVED. THE DEVICE'S POWER MANAGEMENT BOARD 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 24323384 ↗
• MalfunctionFeb 10, 2026Circuit Failure; Charging 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 A SERVICE REQUIRED ALARM INDICATING THE DEVICE FAILED TO CHARGE ACCURATELY. THE DEVICE'S POWER MANAGEMENT BOARD WAS REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, NOT RELATED TO THE REPORTABLE ISSUE THE DEVICE'S POLLEN FILTER, MOTOR BLOWER ASSEMBLY, STIRRING FAN FOAM AND MICRON FILTER WERE REPLACED PREVENTATIVELY. THE DEVICE WAS CLEANED AND TESTED AND PASSED ALL FINAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24304406 ↗
• InjuryJan 27, 2026Output Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A PATIENT EXPERIENCED A "LOW INSPIRATORY PRESSURE" ALARM AND THE PRESSURE DID NOT INCREASE WHILE USING A TRILOGY 100 DEVICE. THE PATIENT'S MOTHER INFORMED A SALES REPRESENTATIVE THAT THE PRESSURE DID NOT INCREASE ALTHOUGH THE CIRCUIT, AND THE PATIENT'S SATURATION LEVEL HAD TEMPORARILY DROPPED TO SIXTY-FOUR PERCENT (64%). THE SALES REPRESENTATIVE SIMULTANEOUSLY CONTACTED THE HOSPITAL, THEN ADVISE THE PATIENT'S MOTHER TO USE THE AMBU BAG AND CALL AN AMBULANCE IF NEEDED. THE SALES REPRESENTATIVE WAS INFORMED THAT THE PATIENT HAD TAKEN A BATH, AND THE PRESSURE HAD NOT DECREASED AFTER THAT. THE SALES REPRESENTATIVE ARRIVED AT THE PATIENT'S HOME, BUT NO ONE WAS HOME. THE PATIENT'S FATHER ARRIVED SHORTLY AFTERWARDS AND INFORMED THE SALES REPRESENTATIVE THAT THE PATIENT WAS TAKEN TO THE HOSPITAL. THE SALES REPRESENTATIVE ARRIVED AT THE HOSPITAL, AND THE PATIENT DID NOT USE A VENTILATOR. THE PATIENT'S SATURATION LEVEL RECOVERED BY THE NURSE USING AN AMBU BAG. THE DEVICE WAS REPLACED WITH ANOTHER MODEL. AS A PRECAUTION, HOSPITALIZATION WAS CONTINUED. THE SALES REPRESENTATIVE INFORMED THE PHYSICIAN THAT THE SET PRESSURE WAS BEING DELIVERED, AS CO

  Patient problems: Insufficient Information

  MAUDE report 24189828 ↗
• MalfunctionJan 13, 2026Circuit Failure; Electrical /Electronic Property Problem

  A TRILOGY 100 VENTILATOR, JAPAN - BT 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 TRILOGY 100 VENTILATOR, JAPAN - BT DEVICE AT THE MANUFACTURER'S SERVICE CENTER, AN "INTERNAL BATTERY DEPLETED " ERROR CODE WAS DISCOVERED IN THE VENTILATOR'S DOWNLOADED EVENT LOG. THE DEVICE'S POWER MANAGEMENT BOARD WAS REPLACED TO ADDRESS THE ISSUE. THE TECHNICIAN PERFORMED PERIODIC MAINTENANCE 1, REPAIR TEST, ALARM TEST, BATTERY TEST, RUN IN TESTS AND CLEANING THEN CONFIRMED THE UNIT OPERATED PROPERLY. THE POLLEN FILTER WAS REPLACED AS REGULATED BY MAINTENANCE PROCEDURE TO PREVENT FAILURE. SOFTWARE VERSION WAS CHECKED. (VER.14.2.05).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24057055 ↗