Trilogy Trilogy 202 Ventilator, United StatesRecalls & reported problems

Summary

The FDA's MAUDE database contains 1,594 adverse event reports that list this exact device (DI 00606959005150), received between Sep 23, 2015 and Jun 15, 2026 — classified as 2 deaths, 4 injuries, 1,588 malfunctions.

The most frequently reported specific device problem is “Circuit Failure” (496 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 1,594 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 15, 2026Mechanical Problem

  THE MANUFACTURER RECIEVED A COMPLAINT THAT A TRILOGY 202 DEVICE IS NOT REACHING THE CORRECT PRESSURES AND IS REQUESTING BENCH REPAIR. AN EVALUATION WAS NOT PERFORMED AS THE PRODUCT HAS REACHED ITS END OF SUPPORT. THE MANUFACTURER PROVIDED THE CUSTOMER WITH THE DOCUMENT ON THE DISCONTINUANCE OF THE CUSTOMER LETTER. NO FURTHER INVESTIGATION ACTIVITIES CAN BE COMPLETED AT THIS TIME. A FINAL IS BEING SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25510979 ↗
• MalfunctionMay 18, 2026Circuit Failure; Failure to Recalibrate

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, A "SERVICE REQUIRED" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG WHICH INDICATES A FAULTY OXYGEN BLENDING MODULE BOARD AND, THE DEVICE FAILED TEST STEPS FOR ACTIVE EXHALATION PURGE VALVE STEP DURING TESTING. THE DEVICE'S O2, 202 PCA KIT AND ACTIVE EXHALATION CONTROL MODULE WERE REPLACED TO ADDRESS THE ISSUES. THE DEVICE PASSED TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25204240 ↗
• MalfunctionMay 14, 2026Circuit Failure; Contamination; Failure to Calibrate; Device Sensing Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE POSITIVE AND NEGATIVE FLOW VERIFY, AND SIGNIFICANT EVENT LOG TEST STEPS HAD FAILED ON A TRILOGY 202 DEVICE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. DURING THE EVALUATION IT WAS NOTED THAT AN ERROR CODE, OXYGEN BLENDING MODULE (OBM) ACCURACY URGENT, WAS OBSERVED IN THE DEVICE'S ERROR LOG HAD CAUSED THE SIGNIFICANT EVENT LOG TEST CASE TO FAIL ON THE DEVICE. THE MANUFACTURER'S SERVICE TECHNICIAN EVALUATED AND DETERMINED THE OBM PRINTED CIRCUIT ASSEMBLY (PCA) HAD CAUSED THE ERROR CODE TO GENERATE AND THE SIGNIFICANT EVENT LOG TEST CASE TO FAIL ON THE DEVICE. THE MANUFACTURER'S SERVICE TECHNICIAN FOUND CONTAMINATION ON THE FLOW ASSEMBLY, BLOWER, MUFFLER, BELLOWS, 200/202/O2 TUBING, THERMISTOR, PORTING BLOCK ADAPTER AND ADAPTER CAP, THERMISTOR O-RING, AND PHYSICAL DAMAGE TO THE STIRRING FAN RETAINER. IN CONCLUSION, THE DEVICE'S OBM PCA, FLOW ASSEMBLY, BLOWER, MUFFLER, BELLOWS, 200/202/O2 TUBING, THERMISTOR, PORTING BLOCK ADAPTER AND ADAPTER CAP, THERMISTOR O-RING, AND PHYSICAL DAMAGE TO THE STIRRING FAN RETAINER WERE REPLACED TO ADDRESS THE ISSUE. THE ROOT CAUSE IS CONFIRMED AT THIS TIME. ADDITIONALLY, DURIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25177706 ↗
• MalfunctionMay 11, 2026Circuit Failure; Adverse Event Without Identified Device or Use Problem

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, A "SERVICE REQUIRED" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S OXYGEN BLENDING MODULE BOARD NEEDS TO BE REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, INCOMING INSPECTION PER (B)(6) SHOWS DAMAGED INLET AIRPATH SCREW BOSSES AND MISSING POWER CORD, CORD RETAINER, AND THREADED CAP, AND ADDITIONALLY THE KEYS ARE INTERMITTENTLY RESPONSIVE, INDICATING A FAULTY FRONT PANEL PCA. CTQ INSPECTION SHOWS DAMAGED ENCLOSURE SEAL. WHILE REPAIRING THE DEVICE, DAMAGE WAS FOUND TO THE OBM HOUSING, STIRRING FAN RETAINER, FILTER DUCT, EXHALATION MODULE, AND THE PORTING BLOCK ADAPTER, AS WELL AS YELLOWING/CONTAMINATION TO THE LOW FLOW TUBING, OBM TUBING, BOTH OBM FLOW ELEMENTS, FLOW SENSOR ASSEMBLY, EXHAUST FAN, AND PORTING BLOCK ADAPTER CAPS. DEVICE PASSED FINAL TEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25141511 ↗
• MalfunctionMay 7, 2026No Display/Image

  A USER CONTACTED THE MANUFACTURER DUE TO A TRILOGY 202 DEVICE EXHIBITING SCREEN PROBLEMS. THEY REPORTED THAT WHEN POWERED UP THE SCREEN COMES UP BLANK AND HAS TO BE POWERED DOWN SEVERAL TIMES BEFORE IT COMES BACK UP AGAIN. THE CUSTOMER ADVISED THE MANUFACTURER CUSTOMER SERVICE THAT THEY WILL BE TAKING RESPONSIBILITY TO CORRECT AND REPAIR THE DEVICE. THE CUSTOMER HAS BEEN NOTIFIED TO CONTACT PHILIPS IF THIS DOES NOT ADDRESS THEIR DEVICE ISSUE AT WHICH POINT A NEW SERVICE ORDER WILL BE CREATED. NO FURTHER INFORMATION WILL BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25113568 ↗
• MalfunctionMar 20, 2026Mechanical Problem; Failure to Calibrate

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING VENTILATOR SERVICE REQUIRED. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. THE TRILOGY 202 WAS RETURNED AND EVALUATED BY A THIRD-PARTY SERVICE CENTER. DURING EVALUATION OF THE ERROR LOGS, AN ERROR CODE RELATED TO THE OXYGEN BLENDING MODULE WAS OBSERVED. ERR_OBM_REPLACE_O2_SENSOR MEANS THERE WAS A FAILURE OF THE O2 SENSOR. THE O2 SENSOR MEASURES AMBIENT OXYGEN CONCENTRATION AND DOES NOT IMPACT THERAPY. THIS IS NOT A REPORTABLE ERROR CODE. THE OXYGEN BLENDING BOARD WAS REPLACED TO ADDRESS THE ISSUE. DURING TESTING OF DEVICE, WHICH OCCURS OUTSIDE OF PATIENT USE, AFTER REPAIR, THE DEVICE FAILED THE CHECK OBM (OXYGEN BLENDING MODULE) -TRILOGY LEAK TEST STEP. THE 200/202/O2 TUBING AND PORTING BLOCK ADAPTER WERE FOUND TO BE WEATHERED AND REPLACED. DEVICE STILL FAILED LEAK TEST. THE OBM TUBING AND GASKET, AS WELL AS THE BLOWER BELLOWS AND CLIP WERE REPLACED. THE DEVICE PASSED ALL TESTING AFTER PARTS REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24650341 ↗
• MalfunctionMar 19, 2026Circuit Failure

  THE MANUFACTURER RECEIVED INFORMATION THAT A TRILOGY 202 VENTILATOR WAS REPORTED TO HAVE A VENTILATOR SERVICE REQUIRED ALARM FOR PREVENTATIVE MAINTENANCE. THERE WAS NO PATIENT INVOLVEMENT, AND NO HARM OR INJURY REPORTED. IT WAS REPORTED THE CUSTOMER REQUESTED BENCH SERVICE TO HAVE THE DEVICE EVALUATED AND REPAIRED FOR WHAT IS NEEDED FOR THE VENTILATOR SERVICE REQUIRED ALARM. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S SERVICE CENTER FOR EVALUATION AND REPAIR. ON DEVICE EVALUATION, A DEVICE ERROR CODE E-344 WAS NOTED IN THE DOWNLOAD ERROR LOG INDICATING AN ISSUE WITH THE ACCURACY OF THE OXYGEN BLENDING MODULE (OBM). DURING BENCH SERVICE, FULL FACTORY CALIBRATION AND TESTING WAS COMPLETED. THE SYSTEM DID NOT MEET THE SPECIFICATION FOR THE PERFORMED SERVICE. IT WAS REPORTED THE DEVICE'S MAIN PRINTED CIRCUIT BOARD ASSEMBLY CAUSED THE ERROR CODE E-344. DUE TO THE OBM ERROR, THE PRINTED CIRCUIT BOARD ASSEMBLY WAS REPLACED. AFTER REPAIR, FULL FACTORY CALIBRATION AND TESTING PROCEDURES WERE COMPLETED. ADDITIONAL FINDINGS NOT RELATED TO THE MALFUNCTION/ISSUE: THE POLLEN FILTER WAS CONTAMINATED AND WAS REPLACED, AND THE PORTING BLOCK WAS MISSING AND WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24637623 ↗
• MalfunctionMar 3, 2026Circuit Failure

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, A "SERVICE REQUIRED" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S BOARD NEEDS TO BE REPLACED TO ADDRESS THE ISSUE. THE DEVICE PASSED FINAL TEST. ADDITIONALLY, INCOMING INSPECTION PER PUR5103123V02 SHOWS DAMAGED FRONT ENCLOSURE, POWER CORD, AND AC POWER INLET, AS WELL AS MISSING TOP PLATE ENCLOSURE AND THREADED CAP. CTQ INSPECTION SHOWS DAMAGED ENCLOSURE SEAL. WHILE REPAIRING THE DEVICE, CONTAMINATION WAS FOUND IN THE MANIFOLD ASSEMBLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24500254 ↗
• MalfunctionMar 3, 2026Failure to Charge; Battery Problem

  THE MANUFACTURER RECEIVED INFORMATION THAT A TRILOGY 202 VENTILATOR INTERNAL BATTERY WAS DEPLETED AND WOULD NOT CHARGE WHEN PLUGGED IN. 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 CONFIRMED. THE DEVICE WAS SERVICED BY A REMOTE SERVICE ENGINEER, AND IT WAS DETERMINED THAT THE BATTERY HAS REACHED ITS END OF SUPPORT WITH NO PARTS OR REPAIR AVAILABLE. THE CUSTOMER WAS PROVIDED WITH A DISCONTINUE LETTER. THE TECHNICIAN DETERMINED THE SYSTEM DOES NOT MEET THE SPECIFICATION FOR THE PERFORMED SERVICE AND IS NOT RETURNED TO USE. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24494134 ↗
• MalfunctionFeb 17, 2026Circuit Failure

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR ROUTINE PREVENTATIVE MAINTENANCE. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, A "SERVICE REQUIRED" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S BOARD NEEDS TO BE REPLACED TO ADDRESS THE ISSUE. NO RESPONSE FROM CUSTOMER AND DEVICE TO BE RETURNED UNREPAIRED. ADDITIONALLY, INCOMING INSPECTION PER (B)(4) SHOWS DAMAGED HANDLE, PORTING BLOCK, AND FRONT, REAR, AND OBM ENCLOSURES, AND MISSING POWER CORD, CORD CLAMP, AND THREADED CAP. ADDITIONALLY, AN UNKNOWN ORANGE SUBSTANCE WAS FOUND CONTAMINATING THE OBM GASKET, MIXER ELEMENT, BOTH FLOW ELEMENTS, AND TUBING. CTQ INSPECTION SHOWS NO ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24369121 ↗
• MalfunctionFeb 13, 2026Electrical /Electronic Property Problem

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, A "SERVICE REQUIRED" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG RELATED TO ERR_RIPC_COMM_TO_OBM_FAILED, WHICH INDICATES A FAULTY OBM WIRE. THE DEVICE'S O2 AND 202 WIRE HARNESS NEEDS TO BE REPLACED TO ADDRESS THE ISSUE. THE DEVICE WAS RETURNED UNREPAIRED PER CUSTOMER REQUEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24330465 ↗
• MalfunctionJan 28, 2026Circuit Failure; Failure to Recalibrate

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, A SERVICE REQUIRED CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG AND THE DEVICE FAILED A TEST STEP FOR OXYGEN BLENDING MODULE NEGATIVE FLOW CALIBRATION. THE DEVICE'S OXYGEN BLENDING MODULE BOARD WAS FOUND FAULTY. ADDITIONALLY, CONTAMINATION WAS ALSO OBSERVED IN THE BLOWER MOTOR, TUBING, AND PORTING BLOCK ADAPTER AND CAPS. THE DEVICE'S OXYGEN BLENDING MODULE BOARD, OXYGEN BLENDING MODULE MANIFOLD, BLOWER MOTOR, TUBING, AND PORTING BLOCK ADAPTER AND CAPS WERE REPLACED TO ADDRESS THE ISSUE. THE DEVICE PASSED THE TEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24206450 ↗
• MalfunctionJan 28, 2026Circuit Failure; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATION SERVICE REQUIRED AND ACTIVE EXHALATION VALVE (AEV) ERROR CODES WERE FOUND DURING PREVENTATIVE MAINTENANCE ON A TRILOGY 202 DEVICE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. DURING THE EVALUATION IT WAS NOTED THAT THE ERROR CODES, AEV FAILURE AND OXYGEN FLOW RAILED LOW, ERROR CODES WERE OBSERVED ON THE DEVICE'S ERROR LOG. THE MANUFACTURER'S SERVICE TECHNICIAN EVALUATED AND DETERMINED THE SENSOR BOARD HAD CAUSED THESE ERROR CODES TO OCCUR ON THE DEVICE. IN CONCLUSION, THE DEVICE'S SENSOR BOARD WAS REPLACED TO ADDRESS THE ISSUE. THE ROOT CAUSE IS CONFIRMED AT THIS TIME. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, THE SPEAKER WAS REPLACED FOR A NON-REPORTABLE ERROR CODE THAT WAS OBSERVED ON THE DEVICE'S ERROR LOG, WHICH WAS UNRELATED TO THE REPORTABLE ISSUE. THE POWER CORD, PLASTIC THREAD CAP, AND CORD RETAINER WERE REPLACED FOR MISSING ON THE DEVICE, WHICH WAS UNRELATED TO THE REPORTABLE ISSUE. THE DEVICE PASSED ALL FINAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24201728 ↗
• MalfunctionJan 28, 2026Computer Software Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATION SERVICE REQUIRED ERROR CODE WAS FOUND ON A TRILOGY 202 DEVICE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. DURING THE EVALUATION IT WAS NOTED THAT AN ERROR CODE, OXYGEN BLENDING MODULE (OBM) ACCURACY URGENT, WAS OBSERVED ON THE DEVICE'S ERROR LOG. THE MANUFACTURER'S SERVICE TECHNICIAN FURTHER EVALUATED, AND THE SOFTWARE WAS OUTDATED ON THE DEVICE. IN CONCLUSION, THE DEVICE'S SOFTWARE WAS UPGRADED TO ADDRESS THE ISSUE. THE ROOT CAUSE IS CONFIRMED AT THIS TIME. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, THE THREADED CAP WAS REPLACED FOR MISSING ON THE DEVICE, WHICH IS UNRELATED TO THE REPORTED ISSUE. THE POLLEN FILTER WAS REPLACED FOR PREVENTATIVE MAINTENANCE UNRELATED TO THE REPORTABLE ISSUE. THE DEVICE PASSED ALL FINAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24201561 ↗
• MalfunctionJan 27, 2026Battery Problem; Charging Problem

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR ROUTINE PREVENTATIVE MAINTENANCE. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, "SERVICE REQUIRED" CODES RELATED TO THE CHARGING OF THE INTERNAL BATTERY WAS OBSERVED. THE DEVICE'S INTERNAL BATTERY WILL BE REPLACED TO ADDRESS THE ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24188114 ↗
• MalfunctionJan 21, 2026Circuit Failure; Leak/Splash; Mechanical Problem; Failure to Recalibrate

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE DEVICE FAILED AT THE DP CALIBRATION STEP DUE TO PRESSURE CONTINUOUSLY FALLING. REPLACED SENSOR BOARD CABLE, DEVICE STILL FAILED TESTING. WHEN CHECKING INSIDE DEVICE FOR FAULTY CONNECTIONS AND FOUND MINOR COSMETIC DAMAGE TO THE REPLACED PORTING BLOCK ADAPTER, SO IT WAS REPLACED AGAIN. DEVICE STILL FAILED TESTING, SO THE TUBING WAS REPLACED AGAIN. DEVICE STILL FAILED TESTING. AT THIS POINT USED THE INDIVIDUAL STEP TESTING PROCEDURE TO DETERMINE THE CAUSE OF THE FAILURES, AND FOUND THAT THE ACTIVE EXHALATION MODULE WAS LIKELY NOT CLOSING FULLY, SO A NEW UNIT WAS INSTALLED AGAIN, HOWEVER THE DEVICE STILL FAILED TESTING, SO THE MAINBOARD WAS REPLACED AS WELL UNDER THE ASSUMPTION THAT A FAULTY SIGNAL WAS PREVENTING THE EXHALATION MODULE FROM CLOSING PROPERLY. DEVICE STILL FAILED TESTING. FURTHER INVESTIGATION FOUND THAT THE SENSOR BOARD WAS LIKELY DEFECTIVE, SO IT WAS REPLACED AGAIN, AND THE DEVICE PASSED THE STEP THAT WAS PREVIOUSLY FAILING, SO THE BOARD HAS BEEN SET ASIDE AS DEFOA. DEVICE THEN FAILED THE OXYGEN BL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24130142 ↗
• MalfunctionJan 15, 2026Circuit Failure

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, A SERVICE REQUIRED CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG ALONG WITH CONTAMINATION. THE DEVICE'S OXYGEN BLENDING MODULE BOARD WAS REPLACED TO ADDRESS THE ISSUE. THE DEVICE PASSED THE FINAL TEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24086534 ↗
• MalfunctionJan 15, 2026Failure to Recalibrate

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR ROUTINE PREVENTATIVE MAINTENANCE. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE DEVICE FAILED A TEST STEP FOR POSITIVE FLOW VERIFY DURING TESTING. DEVICE TO BE RETURNED UNREPAIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24086160 ↗
• MalfunctionJan 15, 2026Mechanical Problem; Failure to Recalibrate

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR ROUTINE PREVENTATIVE MAINTENANCE. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE DEVICE FAILED A TEST STEP FOR DP PURGE VALVE, WITH THE TESTING TECHNICIAN NOTING WHISTLING HEARD FROM THE DEVICE DURING THE TEST. INVESTIGATION FOUND NO OBVIOUS LEAKS, SO THE RECOMMENDATION IS FOR THE REPLACEMENT OF THE PORTING BLOCK ADAPTER AND TUBING. CUSTOMER DECLINED REPAIR UPCHARGE; DEVICE TO BE RETURNED UNREPAIRED. ADDITIONALLY, INCOMING INSPECTION PER PUR5103123 SHOWS DEVICE HAS NO DAMAGED COMPONENTS BUT IS MISSING ITS RUBBER FEET AND THREADED CAP. CTQ INSPECTION SHOWS NO ISSUES. DEVICE ERROR LOGS SHOW NO URGENT SERVICE ALARMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24085825 ↗
• MalfunctionJan 14, 2026Circuit Failure; Mechanical Problem

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, A "SERVICE REQUIRED" CODES WERE FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S BOARD KIT AND WIRE HARNESS WERE REPLACED TO ADDRESS THE ISSUES. DEVICE IS IN BECAUSE IT IS "DISPLAYING A LOW OXYGEN INLET PRESSURE ERROR." CAN CONFIRM ERRORS 344 AND 349 IN THE ERROR LOGS, WHICH COULD BE CAUSING OXYGEN PRESSURE INACCURACY. DEVICE IS ALSO DUE FOR 10K/24-MONTH PM. DEVICE ERROR LOGS SHOW E-344 ERR_OBM_ACCY_URGENT_SERVICE AND E-349 ERR_RIPC_COMM_TO_OBM_FAILED, WHICH INDICATE A FAULTY OXYGEN BLENDING MODULE BOARD AND WIRE HARNESS, RESPECTIVELY. ADDITIONALLY, INCOMING INSPECTION PER (B)(4) SHOWS EVIDENCE OF TOBACCO CONTAMINATION IN THE FRONT, REAR, AND BASE ENCLOSURE, AS WELL AS THE HANDLE AND OXYGEN BLENDING MODULE HOUSING. DEVICE HAS A DAMAGED FRONT ENCLOSURE, AND IS MISSING ITS CORD RETAINER, POWER CORD, CORD CLAMP, WHISPER CAP, AND THREADED CAP. INCOMING CTQ INSPECTION SHOWS NO DAMAGED COMPONENTS. CUSTOMER CANCELLED REPAIR; DEVICE TO BE RETURNED UNREPAIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24072772 ↗
• MalfunctionJan 14, 2026Circuit Failure

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, A SERVICE REQUIRED CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG ALONG WITH CONTAMINATION. THE DEVICE'S OXYGEN BLENDING MODULE BOARD WAS REPLACED TO ADDRESS THE ISSUE. THE DEVICE PASSED THE FINAL TEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24065839 ↗
• MalfunctionJan 13, 2026Failure to Recalibrate

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE DEVICE FAILED TEST STEPS DURING TESTING. THE DEVICE'S O2 MANIFOLD, OBM BLENDER GASKET, AND MOTOR BLOWER WERE REPLACED TO ADDRESS THE ISSUE. THE DEVICE PASSED ALL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24056016 ↗
• MalfunctionJan 13, 2026Circuit Failure; Gas/Air Leak

  THE TRILOGY 202 VENTILATOR WAS RETURNED TO THE THIRD-PARTY 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 AT THE THIRD-PARTY SERVICE CENTER AN ERROR CODE IN RELATION TO (LOW FLOW) WAS RECORDED IN THE DEVICE EVENT LOG AND THE BLENDER GASKET LEAK OCCURRED. IN CONCLUSION THE SYSTEM BOARD AND OXYGEN BLENDER GASKET KITS WERE REPLACED TO ADDRESS THE ISSUES. THE ROOT CAUSE IS CONFIRMED AT THIS TIME. ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, THE POLLEN FILTER WAS REPLACED DUE TO CONTAMINATION, INTERNAL BATTERY PACK WAS REPLACED DUE TO AGE, FRONT ENCLOSURE OVERLAY WAS REPLACED, AND THE WHISPER CAP WAS MISSING AND REPLACED. THE SERVICE CENTER COMPLETED FULL FACTORY CALIBRATION AND TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24051710 ↗
• MalfunctionJan 9, 2026Electrical /Electronic Property Problem

  A TRILOGY 202 VENTILATOR, U.S.A. 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 202 VENTILATOR, U.S.A. DEVICE AT THE MANUFACTURER'S SERVICE CENTER, A "SERVICE REQUIRED" ERR_PROX_PRESS_RAILED ERROR CODE WAS DISCOVERED IN THE VENTILATOR'S DOWNLOADED EVENT LOG. THE TECHNICIAN DOCUMENTED PER SERVICE GUIDE, THIS ERROR COULD INDICATE FAULTY TUBING, OBM MANIFOLD, SENSOR BOARD CABLE, AND/OR SENSOR BOARD. THE TUBING WILL BE CHECKED FOR LEAKS AND REPLACE THEM IF NECESSARY. THERE IS NO DOCUMENTATION OF ANY COMPONENT NEEDING TO BE REPLACED. THE CUSTOMER CANCELLED REPAIR. THE DEVICE TO BE RETURNED UNREPAIRED. ADDITIONALLY, THE DEVICE'S POLLEN FILTER, SD CARD, AND CASE WERE REPLACED PER PERIODIC MAINTENANCE. THE POWER CORD, C7-END, R.A. FEMALE-END, US, POWER CORD CLAMP, AND PLASTIC THREADED CAP WERE REPLACED DUE TO HAVING BEEN MISSING AT INSPECTION. THE HOUSING AND FRONT ENCLOSURE KIT WERE REPLACED HAVING BEEN DAMAGED AT INSPECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24027672 ↗
• MalfunctionJan 8, 2026Failure to Power Up

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE TRILOGY 202 DEVICE WOULD NOT POWER UP. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. A PHILIPS REMOTE SERVICE ENGINEER (RSE) ASSISTED THE CUSTOMER ON THIS ISSUE. THE PHILIPS RSE INFORMED THE CUSTOMER THAT THE DEVICE HAD REACHED END OF SERVICE SO, THERE WAS NO FINDINGS AVAILABLE FOR THIS ISSUE. THE CUSTOMER WAS ADVISED BY THE PHILIPS RSE THAT A THERE WAS A THIRD-PARTY PROVIDER THAT MAY SUPPORT THE REPAIRS OF THE DEVICE. THE PHILIPS RSE PROVIDED THE INFORMATION TO THE CUSTOMER. THERE WERE NO PART(S) REPLACED, OR NO REPAIRS MADE TO THE DEVICE FOR THIS ISSUE. A FINAL REPORT IS BEING SUBMITTED. 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 24011228 ↗

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