Trilogy 00 (REF 1054655)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2,059 adverse event reports that list this exact device (DI 00606959025387), received between Sep 30, 2015 and Jun 26, 2026 — classified as 15 deaths, 38 injuries, 2,006 malfunctions.

The most frequently reported specific device problem is “Failure to Recalibrate” (598 reports).

8 other recalls cover devices cleared under the same FDA submission (K083526); 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 2,059 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 26, 2026Circuit Failure

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE POWER LAMP ON THE TRILOGY 100 DEVICE DID NOT LIGHT EVEN WHEN IT WAS CONNECTED TO THE AC CORD. THE DEVICE WAS REPLACED WITH ANOTHER 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 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. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, THE BLOWER, STIRRING FAN FOAM, AND FORTY-THREE MICRON FILTER WAS REPLACED FOR A NOISE THAT OCCURRED ON THE BLOWER. THIS WAS UNRELATED TO THE REPORTABLE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25642670 ↗
• MalfunctionMay 28, 2026Mechanical Problem; Failure to Calibrate

  THE MANUFACTURER RECEIVED A REPORT THAT A TRILOGY 100 VENTILATOR WAS RETURNED FOR PERIODIC MAINTENANCE. NO PATIENT HARM OR INJURY WAS REPORTED. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. DURING OPERATIONAL TESTING, THE DEVICE FAILED THE O2 LOW FLOW TEST. THE ACTIVE EXHALATION CONTROL MODULE WAS REPLACED TO CORRECT THE ISSUE. ADDITIONALLY, THE POLLEN FILTER, CAPACITOR, BATTERY FAN, EXHAUST FAN ASSEMBLY, STIRRING FAN, 43-MICORN FILTER, MOTOR BLOWER ASSEMBLY, AND STIRRING FAN FOAM WERE REPLACED PER CUSTOMER REQUEST. A CRACK WAS ALSO IDENTIFIED IN THE BASE ENCLOSURE, WHICH REQUIRED REPLACEMENT. THE DETACHABLE BATTERY PACK AND INTERNAL BATTERY WERE NOT REPLACED DUE TO AN EXTENDED DELAY IN AVAILABILITY OF THE REPLACEMENT PARTS. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25319825 ↗
• MalfunctionMay 12, 2026Mechanical Problem; Failure to Calibrate

  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 FAILED AN ACTIVE EXHALATION CONTROL MODULE TEST STEP. 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 25153391 ↗
• MalfunctionApr 28, 2026Circuit Failure; Failure to Calibrate

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE PROXIMAL PRESSURE TEST STEPS HAD FAILED DURING PREVENTATIVE MAINTENANCE 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 BEING EVALUATED AT THE MANUFACTURER SERVICE CENTER WHEN THE REPORTED ISSUE OCCURRED ON THE DEVICE. DURING THE EVALUATION IT WAS NOTED THAT THE DEVICES SENSOR PRINTED CIRCUIT ASSEMBLY (PCA) HAD CAUSED THE PROXIMAL PRESSURE TEST STEPS TO FAIL ON THE DEVICE. IN CONCLUSION, THE DEVICE'S SENSOR PCA WAS REPLACED TO ADDRESS THE ISSUE. THE ROOT CAUSE IS CONFIRMED AT THIS TIME. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, THE MOTOR ASSEMBLY, STIRRING FAN FOAM, AND FORTY-THREE (43) MICRON FILTER WERE REPLACED DUE TO A "LIFE RELATED" SMELL ON THE DEVICE. THIS WAS UNRELATED TO THE REPORTABLE ISSUE. THE CAPACITOR/BATTERY RETAINER WAS REPLACED DUE TO PHYSICAL DAMAGE UNRELATED TO THE REPORTABLE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25017835 ↗
• MalfunctionApr 14, 2026Circuit Failure; Mechanical Problem; Failure to Calibrate; Protective Measures Problem

  THE TRILOGY 100 VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR PREVENTATIVE MAINTENANCE. THE DEVICE WAS NOT IN USE BY A PATIENT AT THE TIME OF THE OCCURRENCE. DURING THE SERVICE OF THE DEVICE AT THE MANUFACTURER SERVICE CENTER, THE DEVICE FAILED THE ACTIVE EXHALATION PURGE VALVE CLOSED, ACTIVE EXHALATION PROPORTIONAL VALVE OPEN AND NURSE CALL ON TEST STEP DURING TESTING. IN CONCLUSION, THE DEVICE'S TRILOGY 100 ACTIVE EXHALATION CONTROL MODULE AND INTERFACE BOARD WERE REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, THE FOLLOWING PARTS WERE REPLACED FOR PERIODIC MAINTENANCE 1: POLLEN FILTER. THE TECHNICIAN PERFORMED REPAIR TEST, ALARM TEST, BATTERY TEST, RUN IN TESTS AND 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 24876879 ↗
• MalfunctionApr 9, 2026Mechanical Problem; Failure to Calibrate; Device Sensing Problem

  THIS NOTIFICATION IS BEING REVIEWED DUE TO THE DEVICE REQUIRING A PREVENTATIVE MAINTENANCE. NO ALLEGATIONS OR INDICATIONS OF MALFUNCTION HAVE BEEN REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE DEVICE FAILED A TEST STEP DURING TESTING. THE DEVICE'S ACTIVE EXHALATION CONTROL MODULE WAS REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, A "SERVICE REQUIRED" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S PRESSURE SENSOR WAS REPLACED TO ADDRESS THE ISSUE. THE DEVICE PASSED ALL FINAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24829295 ↗
• MalfunctionMar 23, 2026Circuit Failure; Mechanical Problem

  THE TRILOGY 100 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 THE DOWN BUTTON / BUTTONS REACTED AS IF PRESSED TWICE WHEN PRESSED ONLY ONCE. THEREFORE, THE FRONT PANEL/KEYPAD LED BOARD WAS REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, COMPONENTS THE FOLLOWING PARTS WERE REPLACED PER THE CUSTOMER'S REQUEST. POLLEN FILTER, CAPACITOR, BATTERY FAN, EXHAUST FAN ASSEMBLY, STIRRING FAN, 43-MICRON FILTER, MOTOR BLOWER ASSEMBLY, STIRRING FAN FOAM. THE TECHNICIAN PERFORMED REPAIR TEST, ALARM CHECK, BATTERY CHECK, RUN IN TESTS, CLEANING THEN CONFIRMED THE UNIT OPERATED PROPERLY. SOFTWARE VERSION WAS CHECKED (VER.14.1.03). THE DETACHABLE BATTERY PACK AND INTERNAL BATTERY HAVE NOT BEEN REPLACED DUE TO A LONG -TERM DELAY IN ARRIVAL OF REPLACEMENT. THE CUSTOMER WILL BE NOTIFIED WHEN THE SUPPLY IS RESUMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24660395 ↗
• MalfunctionJan 8, 2026Circuit Failure; Failure to Calibrate

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE ZERO FLOW VERIFY, AND NEGATIVE FLOW VERIFY TEST STEPS 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 HAVING PREVENTATIVE MAINTENANCE PERFORMED AT THE MANUFACTURER SERVICE CENTER WHEN THIS ISSUE OCCURRED ON THE DEVICE. DURING THE EVALUATION IT WAS NOTED THAT THE DEVICES SENSOR PRINTED CIRCUIT ASSEMBLY (PCA) HAD CAUSED THE TWO TEST STEPS TO FAIL ON THE DEVICE. IN CONCLUSION, THE DEVICE'S SENSOR PCA NEEDS REPLACED TO ADDRESS THE ISSUE. THE ROOT CAUSE IS CONFIRMED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24004314 ↗
• MalfunctionDec 12, 2025Mechanical Problem; Failure to Calibrate; Mechanical Problem; Failure to Calibrate

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ALARM OCCURRED WHILE THE TRILOGY 100, JAPAN DEVICE WAS IN PATIENT USE. IT WAS REPORTED THAT THERE ARE TIMES DURING USE OF THE DEVICE WHEN LOW INSPIRATORY PRESSURE ALARM OCCURS FREQUENTLY. THERE WAS NO ALLEGATION OF HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE TRILOGY 100, JAPAN DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE CUSTOMER'S ALLEGATION WAS CONFIRMED. WHEN A TEST WAS PERFORMED FOR VERIFICATION, THE REPAIR TEST RESULTED IN FAIL, WHICH REVEALED THAT A FAILURE OCCURRED IN THE PART TO CONTROL THE EXHALATION VALVE. THE TECHNICIAN RECOMMENDED REPLACING THE DEVICE'S ACTIVE EXHALATION CONTROL MODULE TO ADDRESS THE ISSUE. THE REPAIR WAS CANCELED DUE TO THE LEASE TERM OF THE DEVICE BEING UP. THE DEVICE WILL BE SCRAPPED. ADDITIONALLY, CONFIRMED THE SOFTWARE VERSION IS 14.1.03.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23792341 ↗
• MalfunctionDec 10, 2025Circuit Failure; Device Sensing Problem; Circuit Failure; Device Sensing Problem

  A TRILOGY 100 VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THERE WAS NO REPORTED PATIENT INVOLVEMENT. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER A VENTILATOR SERVICE REQUIRED CODE WAS FOUND RELATED TO A PROX PRESS RAILED. THE SERVICE TECHNICIAN STATES THAT THE SENSOR PRINTED CIRCUIT ASSEMBLY (PCA) BOARD THAT MOUNTS THE PROXIMAL PRESSURE SENSOR WAS REPLACED. ADDITIONALLY, THE POLLEN FILTER WAS REPLACED. THE ORIGINAL SENSOR PCA WAS SENT TO THE PRODUCT INVESTIGATION LAB FOR FURTHER TESTING. REPAIR TESTING, BATTERY CHECK, VALVE CHECK, RUN IN TESTING, AND CLEANING WERE PERFORMED. THE UNIT OPERATED PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23774707 ↗
• MalfunctionNov 25, 2025Display or Visual Feedback Problem; Electrical /Electronic Property Problem; Optical Problem; Display or Visual Feedback Problem; Electrical /Electronic Property Problem; Optical Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING UPPER HALF OF THE SCREEN BECAME DARK DURING USE OF A TRILOGY 100 VENTILATOR. THE DEVICE WAS NOT REPORTED TO BE IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. THE TRILOGY 100 VENTILATOR WAS RETURNED TO THE MANUFACTURER SERVICE CENTER FOR EVALUATION, AND THE CUSTOMER¿S COMPLAINT WAS NOT DUPLICATED BY OPERATIONAL CHECKING PERFORMED, AND IT WAS CONFIRMED THAT THE SCREEN DISPLAY WAS READABLE. IN ADDITION, THE ERROR LOG WAS CHECKED, AND IT WAS CONFIRMED THAT NO ERROR INDICATING A DEVICE FAILURE HAD BEEN LOGGED. BASED ON THE SITUATION AT THE TIME OF THE EVENT, IT HAS BEEN DETERMINED THAT A TEMPORARY FAILURE OCCURRED IN THE SYSTEMS LCD. THE REPAIR WAS CANCELED, AND THE DEVICE WILL BE SCRAPPED. THE FAULTY LCD WILL BE REMOVED FROM THE DEVICE AND RETURNED TO THE MANUFACTURER SERVICE CENTER FOR FURTHER INVESTIGATION OF THE FAILURE. CONFIRMED THE SOFTWARE VERSION IS 14.1.03. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23646833 ↗
• MalfunctionNov 24, 2025Circuit Failure; Failure to Calibrate; Circuit Failure; Failure to Calibrate

  THE MANUFACTURER RECEIVED INFORMATION OF AN INQUIRY TO CONFIRM THE OPERATION OF PRESSURIZATION TO THE EXHALATION VALVE AND VERIFY THE TIDAL VOLUME IN THE VOLUME-CONTROLLED MODE FOR A TRILOGY100 VENTILATOR, JAPAN DEVICE. THERE WAS NO ALLEGATION OF PATIENT HARM. THE DEVICE WAS NOT REPORTED TO BE IN PATIENT USE. THE TRILOGY 100 DEVICE FAILED AT NEGATIVE FLOW VERIFICATION TEST STEP DURING EVALUATION AT THE MANUFACTURER'S SERVICE CENTER. THE DEVICE'S SENSOR BOARD WAS REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, A PERIODIC MAINTENANCE 1 WAS PERFORMED. THE DEVICE'S POLLEN FILTER WAS REPLACED AS REGULATED BY MAINTENANCE PROCEDURE TO PREVENT FAILURE. THE SERVICE TECHNICIAN PERFORMED REPAIR TEST, ALARM CHECK, BATTERY CHECK, RUN IN TESTS AND CLEANING THEN CONFIRMED THE UNIT OPERATED PROPERLY. THE SOFTWARE VERSION WAS CHECKED. (14.1.03). THE MEASURED TIDAL VOLUME WAS 516 ML WHEN THE SETTING WAS 500 ML WITH CV MODE, ACTIVE PAP< >, < > BREATH RATE: 12 BPM< >, < > INSPIRATORY TIME: 1.0 SECOND>, < > FLOW PATTERN: SQUARE>, < > PEEP: 0HPA, DEEP BREATH: OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23638927 ↗
• MalfunctionNov 5, 2025Circuit Failure; Circuit Failure

  A TRILOGY 100 WAS RETURNED TO THE MANUFACTURER DUE TO THE DEVICE REQUIRING PREVENTATIVE MAINTENANCE. NO ALLEGATIONS OR INDICATIONS OF MALFUNCTION HAVE BEEN REPORTED. UPON EVALUATION OF THE DEVICE, A SYSTEM FAILURE ERROR WAS FOUND. THE DEVICE'S CIRCUIT BOARD WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23479197 ↗
• MalfunctionOct 29, 2025Circuit Failure; Failure to Calibrate; Circuit Failure; Failure to Calibrate

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING WHEN SETTING THE TIDAL VOLUME (VTI) AT FIVE HUNDRED MILLILITER (500 ML) THAT THE AIRFLOW RATE WAS MEASURED AT FOUR HUNDRED TWENTY-FIVE ML (425 ML) HAD OCCURRED 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. DURING THE EVALUATION IT WAS NOTED WHEN MEASURED THE VENTILATION VOLUME USING THE SET VALUE THAT WAS USED, THE VTI WAS AT FOUR HUNDRED SEVENTY-FIVE ML (475 ML); WHICH WAS IN THE ALLOWABLE RANGE, AND IT WAS NOT CONFIRMED THAT THE VALUE WAS DEVIATED FROM THE ALLOWABLE RANGE. THE MANUFACTURER'S SERVICE TECHNICIAN STATED THAT THE "TRILOGY'S TIDAL VOLUME CONTROL ACCURACY IS FIFTEEN ML (15 ML) OR TEN PERCENT (10%) OF THE SET VALUE. THE MANUFACTURER'S SERVICE TECHNICIAN EVALUATED THE DEVICE'S ERROR LOG, AND THERE WERE NO ALARMS INDICATING AN ABNORMALITY OF THE DEVICE HAD OCCURRED. THE MANUFACTURER'S SERVICE TECHNICIAN PERFORMED THE FLOW VERIFICATION TEST STEPS ON THE DEVICE. THE FLOW VERIFICATION TEST STEPS HAD FAILED, WHICH WERE THE ITEM FOR VENTILATION VOLUME. THE MANUFACTURER'S SERVICE TECHNICIAN EVALUAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23418405 ↗
• MalfunctionOct 22, 2025Circuit Failure; Electrical /Electronic Property Problem; Circuit Failure; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A CHECK CIRCUIT ERROR CODE WAS FOUND DURING PREVENTATIVE MAINTENANCE 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 ERROR CODE, CHECK CIRCUIT (E-0291) WAS OBSERVED IN THE DEVICE'S ERROR LOG. THE MANUFACTURER SERVICE TECHNICIAN FURTHER EVALUATED AND DETERMINED THE ERROR CODE WAS GENERATED DUE TO THE SENSOR PRINTED CIRCUIT ASSEMBLY (PCA) BOARD. IN CONCLUSION, THE DEVICE'S SENSOR PCA BOARD WAS REPLACED TO ADDRESS THE ISSUE. THE ROOT CAUSE IS CONFIRMED AT THIS TIME. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, THE POLLEN FILTER WAS REPLACED FOR PREVENTATIVE MAINTENANCE UNRELATED TO THE REPORTABLE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23363568 ↗
• MalfunctionSep 4, 2025No Display/Image; No Display/Image

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A MALFUNCTION OF A TRILOGY 100 VENTILATOR'S TOUCHSCREEN. IT WAS REPORTED THAT THE SCREEN SAVER WOULD NOT CANCEL, EVEN AFTER PRESSING THE SWITCH. THERE WAS NO HARM OR INJURY REPORTED. THE TRILOGY 100 WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND THE CUSTOMER'S COMPLAINT WAS CONFIRMED. ALTHOUGH THERE WAS AIRFLOW BEING DELIVERED, THE WHOLE SCREEN REMAINED COMPLETELY BLACK, AND THE DISPLAY WAS NOT VIEWABLE. THE TECHNICIAN RECOMMENDED REPLACING THE DEVICE'S LCD DISPLAY TO ADDRESS THE ISSUE. THE ROOT CAUSE HAS BEEN DETERMINED TO BE A FAILURE IN THE LCD. THE LCD DISPLAY WAS RETURNED TO THE MANUFACTURER'S PRODUCT INVESTIGATION LABORATORY FOR FURTHER REVIEW. THE PRODUCT INVESTIGATION LABORATORY COULD NOT DUPLICATE THE FAILURE OF THE LCD DISPLAY WHEN INSTALLED INTO THE TRILOGY TEST BED. THE LCD DISPLAY FUNCTIONED AS DESIGNED. THE DISPLAY WAS SCRAPPED. ADDITIONALLY, NOT RELATED TO THE MALFUNCTION, THE LEFT DOWN BUTTON IS OVERLY SENSITIVE AS IF PRESSED TWICE WHEN ONLY PRESSING ONE TIME. THE FRONT PANEL BOARD WAS REPLACED TO ADDRESS THE ISSUE. THE TECHNICIAN PERFORMED REPAIR TESTS, ALARM CHECK, BATTERY CHECK, RUN-IN TESTS, AND CLEANING THEN C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22968702 ↗
• MalfunctionAug 15, 2025No Display/Image; No Display/Image

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THAT A SCREEN WAS COMPLETELY DARK. A SALES REP VISITED AND CONFIRMED THE ISSUE. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER. IT WAS CONFIRMED THAT NO ERROR INDICATING A DEVICE FAILURE WAS RECORDED IN THE ERROR LOG. IT HAS BEEN DETERMINED THAT THE ISSUE WAS CAUSED BY THE LCD FAILURE. THE LCD WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22815314 ↗
• MalfunctionAug 5, 2025Failure to Calibrate; Failure to Calibrate

  A TRILOGY 100 VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THERE WAS NO REPORTED PATIENT INVOLVEMENT. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE DEVICE FAILED A TEST STEP RELATING TO THE ACTIVE EXHALATION PROPORTIONAL VALVE. THE SERVICE TECHNICIAN STATES THAT THE ACTIVE EXHALATION CONTROL MODULE VALVE WAS REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, THE BLOWER, STIRRING FAN FOAM, AND 43 MICRONS FILTER WERE REPLACED DUE TO NOISE. THE FRONT ENCLOSURE WAS REPLACED DUE TO OBSERVED SCRATCHES. 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 22720116 ↗
• MalfunctionAug 4, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  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. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, AN OPERATIONAL CHECK WAS PERFORMED AND THE (RIGHT, LEFT) BUTTONS REACTED AS IF PRESSED TWICE WHEN PRESSED ONLY ONCE. THE FRONT PANEL/KEYPAD LED PCA WAS REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, THE FRONT ENCLOSURE OVERLAY WAS REPLACED DUE TO SCRATCHES. THIS IS NOT RELATED TO THE REPORTABLE MALFUNCTION/ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22705086 ↗
• MalfunctionJul 29, 2025Circuit Failure; Failure to Calibrate; Circuit Failure; Failure to Calibrate

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A LOW CIRCUIT LEAK ALARM OCCURRED ON A TRILOGY 100 VENTILATOR. THE LEAKAGE WAS NOT IMPROVED EVEN BY ADJUSTING THE CIRCUIT STRUCTURE OR CHANGING THE SETTINGS. THERE WAS NO HARM OR INJURY REPORTED. THERE WAS NO REPORTED PATIENT INVOLVEMENT. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE LOW CIRCUIT LEAK ALARM WAS FOUND IN THE DEVICE'S LOG DURING AN OPERATIONAL CHECK. THE SERVICE TECHNICIAN ALSO STATES THAT THE DEVICE FAILED A TEST STEP DURING PREVENTATIVE MAINTENANCE RELATING TO POSITIVE AND ZERO FLOW VERIFICATION. THE SENSOR PRINTED CIRCUIT ASSEMBLY (PCA) BOARD WAS REPLACED TO RESOLVE THE FAILED TEST STEP AND LOW CIRCUIT ALARM ISSUE. REPAIR TESTING, ALARM CHECK, BATTERY CHECK, RUN IN TESTING, AND CLEANING WERE PERFORMED. THE UNIT OPERATED PROPERLY. NO FURTHER INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22648229 ↗
• MalfunctionJul 28, 2025Unexpected Shutdown; Unexpected Shutdown

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE TRILOGY 100 DEVICE HAD SHUT DOWN WITHOUT ANY OPERATION. THE MECHANICAL ENGINEER (ME) RECOGNIZED THAT THEY DEVICE DID NOT OPERATE AND STARTED THE POWER. THE DEVICE OPERATED WITHOUT ANY PROBLEMS, BUT THEY WERE REQUESTING A REPLACEMENT DEVICE. THEY ALLEGED THAT THE DEVICE HAD SHUT DOWN WITHOUT TRIGGERING AN ALARM. A SALES REPRESENTATIVE WENT TO THE CUSTOMER SITE FOR THIS ISSUE. THE SALES REPRESENTATIVE STATED, "THERE WAS HISTORY OF THE POWER BEING TURNED OFF OBSERVED IN THE ALARM LOG." HOWEVER, " THE HOSPITAL NURSE HAD NOT TURNED OFF AND SUSPECTED THAT THE CAUSE WAS THE DEVICE." THE DEVICE WAS REPLACED WITH ANOTHER ONE. THERE WAS NO HARM OR INJURY REPORTED. THE VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE MANUFACTURER¿S SERVICE TECHNICIAN DID NOT CONFIRM THE CUSTOMER¿S ISSUE AND OBSERVED NO "DEVICE INOPERATIVE" ERROR CODES IN THE DEVICE¿S EVENT LOG. THE MANUFACTURER¿S SERVICE TECHNICIAN OBSERVED IN THE OPERATION HISTORY THAT IT WAS CONFIRMED TO TURN OFF THE POWER FOR THIS DEVICE. THE MANUFACTURER¿S SERVICE TECHNICIAN CHECKED THE OPERATION OF THE DEVICE, BUT IT WAS NOT DUPLICATED. THE MANUFACTURER¿S SERVICE TECHNICIA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22639025 ↗
• MalfunctionJun 30, 2025Failure to Calibrate; Failure to Calibrate

  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, THE DEVICE FAILED A TEST STEP DURING TESTING. THE DEVICE'S ACTIVE EXHALATION CONTROL MODULE WAS REPLACED TO ADDRESS THE ISSUE. IN ADDITION OF THE ABOVE EVALUATION, THE TECHNICIAN PERFORMED FINAL TEST, BATTERY CHECK, VALVE CHECK, RUN IN TESTS AND CLEANING THEN CONFIRMED THE UNIT OPERATED PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22367621 ↗
• MalfunctionMay 19, 2025No Display/Image; No Display/Image

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE SCREEN HAD BLACKED OUT. THE PATIENT INFORMED THE SALES REPRESENTATIVE THAT THERE WAS NO PROBLEM WITH THE OPERATION OF THE DEVICE. THE SALE REPRESENTATIVE OBSERVED THE SCREEN BEING BLACKED OUT AND REPLACED THE DEVICE WITH ANOTHER ONE. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE HAS NOT 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 22047456 ↗
• MalfunctionMay 13, 2025Degraded; No Display/Image; Obstruction of Flow; Audible Prompt/Feedback Problem; Degraded; No Display/Image; Obstruction of Flow; Audible Prompt/Feedback Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A TRILOGY 100 VENTILATOR INOPERATIVE CONDITION OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. A REPORT WAS RECEIVED FROM A VISITING NURSE, STATING THAT WHEN AN ALARM WAS SUPPOSED TO SOUND, IT DID NOT SOUND, AND THE DISPLAY WAS BLANK AND INDICATED ONLY THE TIME OF OCCURRENCE. THE EVENT FIRST OCCURRED WHEN SUCTION WAS BEING PERFORMED ON A PATIENT TWICE BETWEEN 12:00PM AND 3:00PM. THE ALARM WHICH HAD USUALLY SOUNDED DID NOT SOUND. THE DISPLAY WAS BLANK AND INDICATED ONLY THE TIME. THE ISSUE WAS RESOLVED BY RESETTING THE DEVICE. THE SECOND EVENT OCCURRED WHEN THE CIRCUIT WAS REMOVED TO WIPE WATER INSIDE THE HOSE AT 10:45PM. THE CUSTOMER STATES IT IS POSSIBLE THAT THIS EVENT OCCURRED BECAUSE THEY REMOVED THE CIRCUIT DURING SUCTION. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. 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 22009418 ↗
• MalfunctionMay 12, 2025No Display/Image; No Display/Image

  A TRILOGY 100 VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE WITH THE ALLEGATION THAT THE LIQUID CRYSTAL DISPLAY (LCD) WAS NOT WORKING. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE LCD SCREEN WAS CONFIRMED TO NOT BE WORKING. THE LCD WAS REPLACED TO ADDRESS THE ISSUE. NO SIGNIFICANT ERROR CODES WERE NOTED IN THE DEIVE DOWNLOAD ERROR LOG. ADDITIONAL FINDINGS NOT RELATED TO THE MALFUNCTION/ISSUE; THE FRONT ENCLOSURE WAS NOTED TO BE DAMAGED. THE OVERLAY WAS REPLACED TO ADDRESS THE ISSUE. THE DEIVE PASSED FINAL TESTING AND WAS CONFIRMED TO BE OPERATING PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22002690 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K083526. One submission often covers many models, so check the product and lot details in each record.

• Z-0884-2023 · Dec 7, 2022 · Open, Classified
  Philips Garbin Ventilator, Model Number 1058180B
• Z-0882-2023 · Dec 7, 2022 · Open, Classified
  Philips Trilogy 100 Ventilator, Model Numbers 1054260, 1054096, U1054260, U1054260B, 1054260B, CA1054096B, BT1054260, 1054096B, R1054260, RSL1054260, CA1054096, R1054260B, R1054655
• Z-1956-2021 · Jun 14, 2021 · Open, Classified
  Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators.
• 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
• Z-0296-2012 · Oct 11, 2011 · Terminated
  Trilogy 100, 200 and 202 Ventilators The device is intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used fo
• Z-1896-2010 · Jun 10, 2010 · Terminated
  Trilogy 100 Ventilator, Model/Catalog Number 1054260, U1054260 (Domestic). Philips Respironics, Monroeville, PA 15146. Provides continuous or intermittent ventilatory support for