Trilogy Trilogy 202 Ventilator InternationalRecalls & reported problems

Summary

The FDA's MAUDE database contains 1,564 adverse event reports that list this exact device (DI 00606959022706), received between Sep 23, 2015 and Jun 22, 2026 — classified as 11 deaths, 10 injuries, 1,543 malfunctions.

The most frequently reported specific device problem is “Circuit Failure” (571 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. 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 1,564 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 22, 2026Circuit Failure; Electrical /Electronic Property Problem

  A TRILOGY 202 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 OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, "SERVICE REQUIRED" ALARMS INDICATING AN OXYGEN BLENDING MODULE FLOW SENSOR FAILURE WERE 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 25578135 ↗
• MalfunctionJun 15, 2026Circuit Failure

  A TRILOGY 202 WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER WITH AN ALLEGATION OF A "VENTILATOR SERVICE REQUIRED" ALARM. NO MEDICAL INTERVENTION WAS SPECIFIED. THE DEVICE WAS NOT REPORTED TO BE IN CLINICAL USE. THE TRILOGY 202 WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR EVALUATION, AND THE CUSTOMER¿S COMPLAINT WAS CONFIRMED. DURING THE EVALUATION IT WAS NOTED THAT THE OXYGEN BLENDING MODULE WAS DEFECTIVE. IN CONCLUSION, THE DEVICE'S PRINTED CIRCUIT ASSEMBLY (PCA) NEEDS REPLACED TO ADDRESS THE ISSUE. SHOULD FURTHER INVESTIGATION PROVIDE NEW INFORMATION THAT IMPACTS THE OUTCOME OF THE INVESTIGATION OR THE ASSOCIATED MEDICAL DEVICE REPORTING, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25502705 ↗
• MalfunctionJun 5, 2026Circuit Failure

  A TRILOGY 202 WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER WITH AN ALLEGATION OF AN OBM (OXYGEN BLENDING MODULE) FAILURE ERROR APPEARING EVERY TIME THE DEVICE TURNED ON. NO MEDICAL INTERVENTION WAS SPECIFIED. THE DEVICE WAS NOT REPORTED TO BE IN CLINICAL USE. THE TRILOGY 202 WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR EVALUATION, AND THE CUSTOMER¿S COMPLAINT WAS CONFIRMED. IN CONCLUSION, THE DEVICE'S OBM CIRCUIT BOARD NEEDS TO BE REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25412487 ↗
• MalfunctionJun 3, 2026Circuit Failure; Electrical /Electronic Property Problem; Failure to Calibrate

  A TRILOGY 202 VENTILATOR, INTERNATIONAL, WAS RETURNED TO A THIRD-PARTY SERVICE CENTER WITH A REPORTED "SERVICE REQUIRED" ERROR CODE THAT APPEARED IMMEDIATELY UPON DEVICE STARTUP. NO PATIENT INVOLVEMENT WAS REPORTED, AND NO INJURY OR ADVERSE EVENT OCCURRED. DURING EVALUATION AT THE THIRD-PARTY SERVICE CENTER, THE REPORTED COMPLAINT WAS CONFIRMED. THE DEVICE DISPLAYED AN ERR_OBM_ACCY_URGENT_SERVICE ERROR CODE. BASED ON DIAGNOSTIC FINDINGS, THE SERVICE TECHNICIAN DETERMINED THAT REPLACEMENT OF THE OXYGEN BLENDER MODULE PRINTED CIRCUIT ASSEMBLY (PCA) WAS REQUIRED TO ADDRESS THE ISSUE. ADDITIONAL INSPECTION IDENTIFIED THE FOLLOWING CONDITIONS REQUIRING CORRECTION: THE FRONT COVER REQUIRED REPLACEMENT DUE TO A MISSING CARD DOOR; THE KEYPAD WAS DISCOLORED; THE HANDLE O-RING WAS DAMAGED; THE POLLEN FILTER REQUIRED REPLACEMENT AS PART OF PREVENTIVE MAINTENANCE; THE HANDLE WAS CRACKED; THE CABLE RETAINER WAS MISSING; AND THE WHISPER CAP WAS MISSING. THE DEVICE WAS OUT OF WARRANTY AND WAS AWAITING CUSTOMER APPROVAL FOR REPAIR AT THE TIME OF THIS REPORT. A FINAL REPORT IS BEING SUBMITTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE FOLLOWING COMPLETION OF THE DEVICE REPAIR THAT IMPACTS THE INV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25383199 ↗
• MalfunctionMay 29, 2026Electrical /Electronic Property Problem; Device Sensing Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THAT A VENTILATOR GENERATED A CONTINUOUS INOPERATIVE ALARM WHEN THE DEVICE WAS POWERED ON. THERE WAS NO ALLEGATION OF PATIENT INVOLVEMENT, HARM, OR INJURY ASSOCIATED WITH THE EVENT. DURING EVALUATION OF THE DEVICE AT A THIRD-PARTY SERVICE PROVIDER, THE FIELD SERVICE ENGINEER (FSE) CONFIRMED THE UNIDENTIFIED INOPERATIVE ERROR CODE. THE FSE DETERMINED THAT THE DEVICE¿S SENSOR BOARD NEEDED TO BE REPLACED TO ADDRESS THE ISSUE. A QUOTATION FOR THE REPAIR WAS SUBMITTED TO THE CUSTOMER; HOWEVER, THERE WAS NO DOCUMENTATION CONFIRMING THAT THE REPAIR WAS COMPLETED. THE DEVICE WAS RETURNED TO THE CUSTOMER IN THE SAME CONDITION. THIS IS A FINAL REPORT. IF NEW INFORMATION BECOMES AVAILABLE FOLLOWING COMPLETION OF THE DEVICE REPAIR THAT CHANGES THE OUTCOME OF THE INVESTIGATION OR ASSOCIATED MEDICAL DEVICE REPORTING, A FOLLOW-UP/SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25336578 ↗
• MalfunctionMay 20, 2026Electrical /Electronic Property Problem; Mechanical Problem; Calibration Problem; Infusion or Flow Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A LOW OXYGEN FLOW OCCURRED ON A TRILOGY 202 VENTILATOR. THE DEVICE WAS NOT REPORTED TO BE IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. PHILIPS IS CURRENTLY INVESTIGATING THIS COMPLAINT. A SUPPLEMENTAL REPORT WILL BE SUBMITTED AS DUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25230660 ↗
• MalfunctionMay 7, 2026Circuit Failure; Electrical /Electronic Property Problem

  THE MANUFACTURER PREVIOUSLY RECEIVED INFORMATION ALLEGING A SERVICE REQUIRED ALARM INDICATING AN ISSUE WITH THE OXYGEN BLENDING MODULE O2 SENSOR WAS OBSERVED. THIS ISSUE IS NOT A REPORTABLE CONDITION. THE EVALUATION HAD NOT YET BEEN COMPLETED. THE PRELIMINARY DEVICE EVALUATION WAS COMPLETED BY A THIRD-PARTY SERVICE CENTER. VENTILATOR INOPERATIVE ALARMS INDICATING MAX REBOOTS WERE OBSERVED. THE DEVICE'S SYSTEM BOARD NEEDS TO BE REPLACED TO ADDRESS THE ISSUES. ADDITIONALLY, NOT RELATED TO THE REPORTABLE ISSUE, THE DEVICE'S OXYGEN BLENDING MODULE WILL BE REPLACED TO ADDRESS THE O2 SENSOR SERVICE REQUIRED ALARM. THIS ISSUE WOULD NOT AFFECT THE DEVICE'S ABILITY TO DELIVER THERAPY AS DESIGNED. A FINAL REPORT IS BEING SUBMITTED. IF NEW INFORMATION BECOMES AVAILABLE FOLLOWING THE COMPLETION OF THE DEVICE REPAIR 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 25116360 ↗
• MalfunctionApr 29, 2026Circuit Failure

  THE MANUFACTURER RECEIVED INFORMATION THAT A TRILOGY 202 VENTILATOR WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR EVALUATION. THERE WAS NO PATIENT INVOLVEMENT, AND NO HARM OR INJURY REPORTED. ON DEVICE EVALUATION, IT WAS DETERMINED THE SENSOR PRINTED CIRCUIT BOARD ASSEMBLY REQUIRED REPLACEMENT DUE TO A SYSTEM FAILURE. THE OXYGEN BLENDING MODULE PRINTED CIRCUIT BOARD ASSEMBLY REQUIRED REPLACEMENT DUE TO FAILURE WITH COMMUNICATION LOST BETWEEN THE HOST AND THE OXYGEN BLENDING MODULE. NO COMPONENTS WERE REPLACED; THE DEVICE WAS SCRAPPED. ADDITIONAL FINDINGS NOT RELATED TO THE MALFUNCTION/ISSUE: SPEAKER #1 WAS NOTED TO HAVE FAILED EVIDENCED BY ERROR CODE E-106 WHICH INDICATES NO IMPACT ON THERAPY. THE WHISPER CAP WAS NOTED TO BE CONTAMINATED. THE HANDLE O-RINGS WERE DAMAGED. THE OXYGEN BLENDING MODULE GASKET WAS LEAKING AIR. RUBBER FEET WERE DAMAGED/MISSING. THE POLLEN FILTER AND MAINTENANCE LABELS NEEDED REPLACED DUE TO PREVENTIVE MAINTENANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25028689 ↗
• MalfunctionApr 28, 2026Circuit Failure; Calibration Problem

  A TRILOGY 202 VENTILATOR WAS RETURNED TO A THIRD PARTY SERVICE CENTER REPRESENTATIVE MAINTENANCE. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. DURING EVALUATION OF THE DEVICE AT THE THIRD PARTY SERVICE CENTER, THE DEVICE FAILED A REPAIR TEST STEP RELATING TO 'NEGATIVE FLOW VERIFICATION.' THE SERVICE TECHNICIAN STATES THAT THE INTERFACE PRINTED CIRCUIT ASSEMBLY (PCA) BOARD WAS REPLACED DUE TO MULTIPLE COMMUNICATION ERRORS IN ORDER TO RESOLVE THE TEST STEP FAILURE. IT IS NOTED THAT THE DC1 AND HV1 FORM WAS INCORRECTLY PROCESSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25024104 ↗
• MalfunctionApr 10, 2026Leak/Splash; Failure to Calibrate

  THE MANUFACTURER RECIEVED INFORMATION ALLEGING A VENTILATOR SERVICE REQUIRED ALARM OCCURRED ON A TRILOGY 202 VENTILATOR. NO MEDICAL INTERVENTION WAS SPECIFIED. THE DEVICE WAS NOT REPORTED TO BE IN CLINICAL USE AT THE TIME OF THE ALLEGATION. THE TRILOGY 202 VENTILATOR WAS RETURNED TO THE MANUFACTURER'S SERVICE CENTER FOR EVALUATION, AND THE CUSTOMER'S COMPLAINT WAS CONFIRMED. DURING THE EVALUATION OF THE DEVICE, IT WAS NOTED THAT THE DEVICE FAILED A LEAK TEST. IN CONCLUSION, THE DEVICE'S PCA SENSOR NEEDS TO BE REPLACED TO ADDRESS THE ISSUE. SHOULD FURTHER INVESTIGATION PROVIDE NEW INFORMATION THAT IMPACTS THE OUTCOME OF THE INVESTIGATION OR THE ASSOCIATED MEDICAL DEVICE REPORTING, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24844378 ↗
• MalfunctionApr 7, 2026Circuit Failure; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR SERVICE REQUIRED ALARM HAD OCCURRED ON A TRILOGY 202 DEVICE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. THE TRILOGY 202 DEVICE WAS EVALUATED BY A THIRD-PARTY SERVICE TECHNICIAN, AND THE CUSTOMER¿S COMPLAINT WAS CONFIRMED. DURING THE EVALUATION IT WAS NOTED THAT ERROR CODES, PROXIMAL PRESSURE RAILED AND DRIFT PROXIMAL PRESSURE TOO HIGH, WERE OBSERVED IN THE DEVICE'S ERROR LOG. THE THIRD-PARTY SERVICE TECHNICIAN EVALUATED AND DETERMINED THE OXYGEN BLENDING MODULE (OBM) PRINTED CIRCUIT ASSEMBLY (PCA) AND OXYGEN (O2) PCA HAD CAUSED THESE TWO ERROR CODES TO OCCUR ON THE DEVICE. IN CONCLUSION, THE DEVICE'S OBM PCA AND O2 PCA NEED REPLACING TO ADDRESS THE ISSUE. A QUOTE WAS PROVIDED TO THE CUSTOMER FOR REPAIRS TO BE MADE FOR THIS ISSUE. NO REPAIRS OR PARTS WERE REPLACED AT THIS TIME. THE ROOT CAUSE IS CONFIRMED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24803327 ↗
• MalfunctionApr 7, 2026Circuit Failure

  THE MANUFACTURER RECEIVED INFORMATION THAT A TRILOGY 202 VENTILATOR WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR COMPLETION OF DEVICE EVALUATION. ON DEVICE EVALUATION, ERROR CODE E-344 WAS NOTED IN THE DEVICE ERROR LOG INDICATING AN OXYGEN BLENDING MODULE ACCURACY ISSUE. THIS IS POTENTIALLY A FAILURE OF THE OXYGEN BLENDING MODULE, WHICH MAY IMPACT THERAPY (DELIVERY OF OXYGEN). THE OXYGEN BLENDING MODULE PRINTED CIRCUIT BOARD ASSEMBLY WAS REPLACED TO ADDRESS THIS ISSUE. THE DEVICE PASSED EVALUATION AND REPAIR. ADDITIONAL FINDINGS NOT RELATED TO THE MALFUNCTION/ISSUE: RUBBER FEET WERE DAMAGED AND ONE WAS MISSING AND REQUIRED REPLACEMENT. THE FRONT ENCLOSURE WAS DAMAGED AND REQUIRED REPLACEMENT. THE HANDLE O-RINGS WERE DAMAGED AND REQUIRED REPLACEMENT. COMPONENTS WERE REPLACED DUE TO PREVENTATIVE MAINTENANCE SCHEDULE. THE MACHINE FLOW SENSOR WAS CONTAMINATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24799840 ↗
• MalfunctionApr 6, 2026Circuit Failure; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING VENTILATOR SERVICE REQUIRED ERROR CODE WAS OBSERVED DURING SERVICE OF TRILOGY 202 DEVICE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. THE TRILOGY 202 DEVICE WAS EVALUATED BY A THIRD-PARTY SERVICE ENGINEER. DURING THE EVALUATION IT WAS NOTED THAT THE THIRD-PARTY SERVICE ENGINEER OBSERVED AN ERROR CODE, OXYGEN BLENDING MODULE ACCURACY URGENT, IN THE DEVICE'S ERROR LOG. THE THIRD-PARTY SERVICE ENGINEER FURTHER EVALUATED AND DETERMINED THE OXYGEN (O2) PRINTED CIRCUIT ASSEMBLY (PCA) BOARD HAD CAUSED THE ERROR CODE TO OCCUR ON THE DEVICE. IN CONCLUSION, THE DEVICE'S O2 PCA BOARD WAS REPLACED TO ADDRESS THE ISSUE. THE ROOT CAUSE IS CONFIRMED AT THIS TIME. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, THE SENSOR BOARD, KEYPAD, FILTER, AND SD CARD WERE REPLACED UNRELATED TO THE REPORTABLE ISSUE. THE DEVICE PASSED ALL FINAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24793714 ↗
• MalfunctionMar 30, 2026Circuit Failure; Electrical /Electronic Property Problem

  A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION A SERVICE REQUIRED ALARM CONDITION INDICATING AN AIR FLOW SENSOR FAILURE WAS OBSERVED IN THE DEVICE'S DOWNLOADED EVENT LOG. THE DEVICE'S OXYGEN BLENDING MODULE BOARD WAS REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, NOT RELATED TO THE REPORTABLE ISSUE, AN ALARM INDICATING THE MOTOR CAPACITOR NEEDED REPLACED. THE DEVICE WILL CONTINUE TO OPERATE AS DESIGNED. THE CAPACITOR WAS REPLACED TO ADDRESS THE ISSUE. SEVERAL COMPONENTS WERE REPLACED DUE TO DAMAGE OR CONTAMINATION. THE DEVICE WAS TESTED AND PASSED ALL FINAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24717478 ↗
• MalfunctionMar 17, 2026Battery Problem

  THE TRILOGY 202 VENTILATOR WAS EVALUATED BY A REMOTE SERVICE ENGINEER FOR THE COMPLAINT OF BATTERY BACKUP ISSUES. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. DURING THE EVALUATION THE DEVICE REQUIRED A FOLLOW UP BY A THIRD-PARTY SERVICE ONSITE SERVICE ENGINEER AND THE CUSTOMERS COMPLAINT WAS CONFIRMED. THE SERVICE ENGINEER CHECKED THE DEVICE AND FOUND THAT THE DEVICE WAS NOT SWITCHING ON, WHILE ON BATTERY OR AC SOURCE. THEREFORE, SERVICE ENGINEER PROVIDED A WORK AROUND SOLUTIONS TO THE CUSTOMER AND RESET THE INTERNAL CONNECTION WHICH RESOLVED THE ISSUE. THE SYSTEM MEETS THE SPECIFICATION FOR THE PERFORMED SERVICE AND WAS RETURNED TO THE CUSTOMER. A GFE ATTEMPT IS BEING MADE TO GATHER ADDITIONAL INFORMATION REGARDING THE REPAIR OF THE DEVICE. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24619400 ↗
• MalfunctionMar 9, 2026Circuit Failure; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THAT A VENTILATOR SERVICE REQUIRED ERROR CODE WAS FOUND DURING PREVENTATIVE MAINTENANCE ON A TRILOGY 202 DEVICE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. THE TRILOGY 202 DEVICE WAS BEING EVALUATED AT A THIRD-PARTY SERVICE CENTER SERVICE CENTER WHEN THE REPORTED ISSUE OCCURRED ON THE DEVICE. DURING THE EVALUATION OF THE DEVICE, IT HAD FAILED OXYGEN BLENDING MODULE (OBM) CALIBRATION TESTING ON THIS DEVICE. THE THIRD-PARTY SERVICE TECHNICIAN FOUND AN ERROR CODE, OXYGEN BLENDING MODULE (OBM) ACCURACY URGENT SERVICE, WAS OBSERVED ON THE DEVICE'S ERROR LOG. THE THIRD-PARTY SERVICE TECHNICIAN FURTHER EVALUATED AND DETERMINED THE OBM PRINTED CIRCUIT ASSEMBLY (PCA) HAD CAUSED THE OBM CALIBRATION TESTING TO FAIL ON THE DEVICE. IN CONCLUSION, THE DEVICE'S OBM PCA WAS REPLACED TO ADDRESS THE ISSUE. THE ROOT CAUSE IS CONFIRMED AT THIS TIME. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, THE THIRD-PARTY SERVICE TECHNICIAN HEARD A LOUD WHISTLING VIBRATION WHEN PRODUCING THE HIGH PRESSURES AND ALLEGED IT SOUNDED LIKE A VALVE WAS NOT SEATED CORRECTLY ON THE DEVICE. THE THIRD-PARTY SERVICE TECHNICIAN INSPECTED THE DEVICE AN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24549154 ↗
• MalfunctionFeb 12, 2026Circuit Failure; Computer Software Problem; Electrical /Electronic Property Problem; Failure to Calibrate

  A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION AFTER PREVIOUS REPAIR. THERE WAS NO HARM OR INJURY REPORTED. THIS DEVICE WAS RETURNED PREVIOUSLY IN APRIL 2025 FOR THE SAME ISSUE AND THE OXYGEN BLENDING MODULE WAS REPLACED AT THAT TIME. DURING THE EVALUATION, SERVICE REQUIRED ALARM CONDITIONS INDICATING A FAILURE OF THE OXYGEN BLENDING MODULE AND A FAILURE TO COMMUNICATE WITH THE OXYGEN BLENDING MODULE WERE OBSERVED AGAIN. THE DEVICE'S OXYGEN BLENDING MODULE NEEDS TO BE REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, NOT RELATED TO THE REPORTABLE ISSUE, THE DEVICE'S RUBBER FEET WERE MISSING AND NEED REPLACED. THE DEVICE'S POLLEN FILTER AND PREVENTIVE MAINTENANCE LABEL WILL BE REPLACED PER PREVENTIVE MAINTENANCE PROTOCOL. A FINAL REPORT IS BEING SUBMITTED. IF NEW INFORMATION BECOMES AVAILABLE FOLLOWING THE COMPLETION OF THE DEVICE REPAIR 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 24324065 ↗
• InjuryFeb 9, 2026Insufficient Flow or Under Infusion; Failure to Calibrate; Gas/Air Leak

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A MALFUNCTION OCCURRED ON A TRILOGY EV300 DEVICE, IN WHICH THE VENTILATOR DID NOT DELIVER THE SELECTED VOLUMES IN ANY VENTILATION MODE AND DISPLAYED A MESSAGE INDICATING THE DEVICE NEEDS SERVICING. NO PATIENT IMPACT OR MEDICAL INTERVENTION WAS SPECIFIED, AND CLINICAL USE WAS NOT CONFIRMED. PHILIPS IS CURRENTLY INVESTIGATING THIS COMPLAINT; HOWEVER, THE DEVICE EXAMINATION HAS NOT BEGUN BECAUSE THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24300591 ↗
• MalfunctionJan 28, 2026Circuit Failure

  THE MANUFACTURER RECEIVED A COMPLAINT OF ¿ALARM SERVICE REQUIRED¿ FOR A TRILOGY 202 VENTILATOR. THE DEVICE WAS NOT REPORTED TO BE IN PATIENT USE AT THE TIME OF THE EVENT, AND NO PATIENT INVOLVEMENT WAS REPORTED. THE TRILOGY 202 WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR EVALUATION, AND THE CUSTOMER¿S COMPLAINT WAS CONFIRMED. DURING THE EVALUATION, IT WAS NOTED THAT MULTIPLE SERVICE-REQUIRED ERROR CODES WERE IDENTIFIED, INDICATING OXYGEN BLENDING MODULE (OBM)¿RELATED FAULTS AND LOSS OF COMMUNICATION BETWEEN THE HOST AND THE OBM, WHICH MAY IMPACT THERAPY DELIVERY. THE OBM PRINTED CIRCUIT ASSEMBLY (PCA) WAS REPLACED TO RESOLVE THE ISSUE. A FINAL REPORT IS BEING SUBMITTED. IF NEW INFORMATION BECOMES AVAILABLE, A FOLLOW-UP/SUPPLEMENTAL REPORT WILL BE COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24206304 ↗
• MalfunctionJan 28, 2026Circuit Failure; Battery Problem

  THE MANUFACTURER RECEIVED A REPORT THAT A TRILOGY 202 VENTILATOR WAS RETURNED FOR ROUTINE PREVENTIVE MAINTENANCE. THERE WERE NO REPORTS OR ALLEGATIONS OF PATIENT HARM OR INJURY. THE VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION. REVIEW OF THE DEVICE LOG FILES IDENTIFIED A ¿VENTILATOR SERVICE REQUIRED¿ ERROR INDICATING A LOSS OF COMMUNICATION BETWEEN THE HOST CONTROLLER AND THE OXYGEN BLENDING MODULE (OBM). TO ADDRESS THIS ISSUE, THE OXYGEN BLENDING MODULE (OBM) PRINTED CIRCUIT ASSEMBLY (PCA) WAS REPLACED. ADDITIONALLY, A SEPARATE ¿VENTILATOR SERVICE REQUIRED¿ ERROR WAS IDENTIFIED INDICATING THAT THE INTERNAL LITHIUM-ION BATTERY STATE OF HEALTH WAS LESS THAN OR EQUAL TO 50%, WITH FULL CHARGE CAPACITY (FCC) BELOW 51% OF THE DESIGN CAPACITY. THIS CONDITION REFLECTS EXPECTED BATTERY LIFE HAS DECLINED DUE TO USE. THE ASSOCIATED ALARM IS INTENDED TO NOTIFY THE USER THAT BATTERY LIFE HAS DECLINED. WHILE THE BATTERY IS STILL FUNCTIONAL AND THE DEVICE COULD CONTINUE TO OPERATE USING AC POWER, THE BATTERY IS NO LONGER FUNCTIONING TO SPECIFICATION. THE INTERNAL BATTERY WAS REPLACED TO ADDRESS THIS CONDITION. FOLLOWING SERVICE, THE DEVICE SUCCESSFULLY PASSED ALL REQUIR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24200354 ↗
• MalfunctionJan 28, 2026Circuit Failure

  THE MANUFACTURER RECEIVED A COMPLAINT OF ¿ALARM SERVICE REQUIRED¿ FOR A TRILOGY 202 VENTILATOR. THE DEVICE WAS NOT REPORTED TO BE IN PATIENT USE AT THE TIME OF THE EVENT, AND NO PATIENT INVOLVEMENT WAS REPORTED. THE TRILOGY 202 WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR EVALUATION, AND THE CUSTOMER¿S COMPLAINT WAS CONFIRMED. DURING THE EVALUATION, IT WAS NOTED THAT MULTIPLE SERVICE-REQUIRED ERROR CODES WERE IDENTIFIED, INDICATING OXYGEN BLENDING MODULE (OBM)¿RELATED FAULTS AND LOSS OF COMMUNICATION BETWEEN THE HOST AND THE OBM, WHICH MAY IMPACT THERAPY DELIVERY. THE OBM PRINTED CIRCUIT ASSEMBLY (PCA) WAS REPLACED TO RESOLVE THE ISSUE. A FINAL REPORT IS BEING SUBMITTED. IF NEW INFORMATION BECOMES AVAILABLE, A FOLLOW-UP/SUPPLEMENTAL REPORT WILL BE COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24198421 ↗
• MalfunctionJan 27, 2026Battery Problem

  THE MANUFACTURER RECEIVED INFORMATION THAT A TRILOGY 202 VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION OF AN ALLEGED VENTILATOR SERVICE REQUIRED ALARM. THERE WAS NO PATIENT INVOLVEMENT, AND NO HARM OR INJURY REPORTED. ON DEVICE EVALUATION, VENTILATOR SERVICE REQUIRED ERROR CODE E-195 WAS NOTED INDICATING THE BATTERY LIFE HAS DECLINED DUE TO USE. THE BATTERY IS STILL FUNCTIONAL, AND AC POWER CAN STILL BE USED; HOWEVER, THE BATTERY IS NOT FUNCTIONING TO SPECIFICATION. THE INTERNAL LITHIUM-ION BATTERY REQUIRES REPLACEMENT TO ADDRESS THIS ISSUE. ADDITIONAL FINDINGS NOT RELATED TO THE MALFUNCTION/ISSUE: THE WHISPER CAP, MICRON FILTER, BLOWER, TUBING AND FLOW SENSOR ASSEMBLY ARE CONTAMINATED WITH DUST. THE OXYGEN BLENDING MODULE GASKET WAS KINKED. THERE WERE NO REPORTED DEVICE ERROR CODES ASSOCIATED WITH THESE ISSUES. A FINAL REPORT IS BEING SUBMITTED. IF NEW INFORMATION BECOMES AVAILABLE FOLLOWING THE COMPLETION OF THE DEVICE REPAIR 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 24192603 ↗
• MalfunctionJan 26, 2026Gas Output Problem; Mechanical Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR'S FLOW FAILED TO BE ADEQUATE AND THE TIDAL VOLUME WAS NOT DELIVERING. THERE WAS NO HARM OR INJURY REPORTED. THERE WAS NO EVIDENCE THE DEVICE WAS IN PATIENT USE. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE ISSUE WAS DUPLICATED. THE DEVICE'S O2 CELL MALFUNCTIONED AND WAS REPLACED TO ADDRESS THE ISSUE. THEN DEVICE WAS TESTED AND WORKS AS DESIGNED. THE DEVICE WAS RETURNED TO THE CUSTOMER IN WORKING ORDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24176526 ↗
• MalfunctionJan 22, 2026Circuit Failure; Failure to Calibrate

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A TRILOGY 202 VENTILATOR REQUIRES MAINTENANCE SERVICE. THERE WAS NO PATIENT INVOLVEMENT, AND NO HARM OR INJURY REPORTED. THE DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION WITH THE FOLLOWING FINDINGS: A CRITICAL VENTILATOR SERVICE REQUIRED ERROR CODE E-147 WAS NOTED IN THE DEVICE'S DOWNLOAD ERROR LOG INDICATING THE PROXIMAL PRESSURE SENSOR HAS DRIFTED SO MUCH THAT THE DEVICE CANNOT ADJUST FOR IT. THE DEVICE WAS CONFIRMED TO HAVE BEEN POWERED ON AT THE TIME THIS EVENT OCCURRED. EVALUATION DETERMINED THE SENSOR PRINTED CIRCUIT BOARD ASSEMBLY REQUIRED REPLACEMENT TO ADDRESS THIS ISSUE. ADDITIONAL FINDINGS NOT RELATED TO THE MALFUNCTION/ISSUE: THE RUBBER FEET AND THE WHISPER CAP WERE MISSING AND REQUIRED REPLACEMENT. THE WARNING LABEL AND SERIAL NUMBER LABEL HAD SCRATCHES ON THEM AND REQUIRED REPLACEMENT, THE FRONT ENCLOSURE REQUIRED REPLACEMENT WITH THE NEW VERSION SO THE SAFETY DATA (SD) CARD COULD NO LONGER HAVE SPACE TO SLIDE AROUND INSIDE THE DEVICE. THE PORTING BLOCK WAS DEFORMED AND REQUIRED REPLACEMENT. THE OXYGEN BLENDING MODULE GASKET WAS NOTED TO BE CONTAMINATED AND REQUIRED REPLACEMENT. THE POLLEN FILTER NEE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24145604 ↗
• MalfunctionJan 21, 2026Circuit Failure

  THE MANUFACTURER RECEIVED A COMPLAINT OF ¿ALARM SERVICE REQUIRED¿ FOR A TRILOGY 202 VENTILATOR. THE DEVICE WAS NOT REPORTED TO BE IN PATIENT USE AT THE TIME OF THE EVENT, AND NO PATIENT INVOLVEMENT WAS REPORTED. THE TRILOGY 202 WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR EVALUATION, AND THE CUSTOMER¿S COMPLAINT WAS CONFIRMED. DURING THE EVALUATION, IT WAS NOTED THAT MULTIPLE SERVICE-REQUIRED ERROR CODES WERE IDENTIFIED, INDICATING OXYGEN BLENDING MODULE (OBM)¿RELATED FAULTS AND LOSS OF COMMUNICATION BETWEEN THE HOST AND THE OBM, WHICH MAY IMPACT THERAPY DELIVERY. THE OBM PRINTED CIRCUIT ASSEMBLY (PCA) WAS REPLACED TO RESOLVE THE ISSUE. A FINAL REPORT IS BEING SUBMITTED. IF NEW INFORMATION BECOMES AVAILABLE, A FOLLOW-UP/SUPPLEMENTAL REPORT WILL BE COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24141570 ↗

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