Trilogy Trilogy 202 Ventilator, CanadaRecalls & reported problems

Summary

The FDA's MAUDE database contains 129 adverse event reports that list this exact device (DI 00606959022799), received between Dec 9, 2015 and Jun 17, 2026 — classified as 2 injuries, 127 malfunctions.

The most frequently reported specific device problem is “Circuit Failure” (52 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 129 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2026Circuit Failure; Electrical /Electronic Property Problem

  A TRILOGY 202 VENTILATOR DEVICE HAD A VENTILATOR SERVICE REQUIRED ERROR MESSAGE AND THE DEVICE COULD NOT BE USED WHILE THE MESSAGE WAS DISPLAYED. THERE WAS NO ALLEGATION OF HARM OR INJURY REPORTED. THE DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. DURING THE EVALUATION, THE SERVICE TECHNICIAN OBSERVED ERROR CODE E349 R VENTILATOR SERVICE REQUIRED (ERR_RIPC_COMM_TO_OBM_FAILED), WHICH IS A COMMUNICATION LOSS BETWEEN THE HOST AND THE OXYGEN BLENDER MODULE (OBM). THE OBM PCA BOARD WAS REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, A R VENT SERVICE REQUIRED ERROR CODE E344 (ERR_OBM_ACCY_URGENT_SERVICE) WAS DISCOVERED, AND THE ACTIVE EXHALATION CONTROL MODULE WAS REPLACED. A FULL REPAIR AND CALIBRATION TEST WAS CONDUCTED AND THE DEVICE PASSED TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25538189 ↗
• MalfunctionJun 12, 2026Mechanical Problem

  A TRILOGY 202 VENTILATOR WAS EVALUATED DURING PREVENTATIVE MAINTENANCE AT A THIRD-PARTY SERVICE CENTER. THERE WAS NO PATIENT INVOLVEMENT, AND NO HARM OR INJURY WAS REPORTED. DURING PREVENTATIVE MAINTENANCE, IT WAS NOTED THE OXYGEN BLENDING MODULE REQUIRED REPLACEMENT AS EVIDENCED BY RECORD OF DEVICE ERROR CODE E-344 INDICATING OXYGEN BLENDING MODULE ACCURACY ISSUE. THE DEVICE'S OXYGEN BLENDING MODULE WAS REPLACED TO ADDRESS THE ISSUE. AFTER REPLACEMENT OF THE OXYGEN BLENDING MODULE, THE DEVICE PASSED TESTING AND WAS CONFIRMED TO OPERATE PROPERLY WITH NO FURTHER ISSUE DETECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25494487 ↗
• MalfunctionJun 3, 2026Circuit Failure

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR SERVICE REQUIRED ALARM OCCURRED ON A TRILOGY 202 DEVICE DURING PREVENTATIVE MAINTENANCE. NO MEDICAL INTERVENTION WAS SPECIFIED. THE DEVICE WAS NOT REPORTED TO BE IN CLINICAL USE AT THE TIME OF THE ALLEGATION. THE TRILOGY 202 DEVICE WAS RETURNED AND EVALUATED BY A PHILIPS ENGINEER. TROUBLESHOOTING IDENTIFIED THE OBM (OXYGEN BLENDING MODULE) AS THE LIKELY SOURCE OF THE "VENTILATOR SERVICE REQUIRED" ERROR. THE OBM WAS REPLACED SUCCESSFULLY, AFTER WHICH THE ERROR CLEARED, AND THE DEVICE PASSED OPERATIONAL VERIFICATION TESTING. A FINAL REPORT IS BEING SUBMITTED. IF NEW INFORMATION BECOMES AVAILABLE FOLLOWING FURTHER EVALUATION THAT CHANGES THE OUTCOME OF THE INVESTIGATION AND ASSOCIATED MEDICAL DEVICE REPORTING, A SUPPLEMENTAL REPORT WILL BE COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25379078 ↗
• MalfunctionMay 20, 2026Circuit Failure; Electrical /Electronic Property Problem

  A TRILOGY 202 VENTILATOR WAS EVALUATED BY A THIRD-PARTY FIELD SERVICE ENGINEER FOR PREVENTATIVE MAINTENANCE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. DURING THE EVALUATION IT WAS NOTED AN ERROR CODE IN RELATION TO AIR_FLOW_SENSOR_FAILED WAS RECORDED IN THE DEVICE EVENT LOG. IN CONCLUSION, THE DEVICE'S OXYGEN BLENDER MODULE WAS REPLACED TO ADDRESS THE ISSUE. THE DEVICE PASSED ALL TEST, AND THE SYSTEM MEETS THE SPECIFICATION FOR THE PERFORMED SERVICE AND IS RETURNED TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25232778 ↗
• MalfunctionMay 19, 2026Circuit Failure; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THAT WHEN POWER WAS TURNED ON, AND APPROXIMATELY ONE HOUR LATER, A RED ERROR MESSAGE APPEARED ON THE SCREEN OF A TRILOGY 202 VENTILATOR CANADA DEVICE. ACCORDING TO THE EVENT LOG, THIS OCCURRED ON EVERY POWER-ON AND AFTER APPROXIMATELY ONE HOUR OF USE FOR ABOUT ONE WEEK. THE MESSAGE DISAPPEARED WHEN RESET WAS PRESSED. ACCORDING TO THE PATIENT, THE VENTILATOR CONTINUED TO FUNCTION WITHOUT ISSUE. NO HARM OR INJURY WAS REPORTED. THE TRILOGY 202 VENTILATOR DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE MANUFACTURER'S INVESTIGATION IS ONGOING. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25223521 ↗
• MalfunctionFeb 9, 2026Electrical /Electronic Property Problem; Charging Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR WAS ALARMING FOR SERVICE REQUIRED ALARM CONDITIONS INDICATING THE INTERNAL BATTERY HAD A CHARGING ISSUE AND THE OXYGEN BLENDING MODULE FAILED TO FUNCTION AS DESIGNED. THERE WAS NO HARM OR INJURY REPORTED. THERE WAS NO EVIDENCE THE DEVICE WAS IN PATIENT USE. THE DEVICE WAS EVALUATED BY THE MANUFACTURER'S FIELD SERVICE ENGINEER (FSE) AND THE INTERNAL BATTERY CHARGING ISSUE WAS CONFIRMED. THE DEVICE'S INTERNAL BATTERY WAS REPLACED TO ADDRESS THE ISSUE. THE "SERVICE REQUIRED" ALARM INDICATING AN ISSUE WITH THE OXYGEN BLENDING MODULE O2 SENSOR WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. FOR ALL INSTANCES OF THE ALARM, THE ERROR LOG INDICATES THAT THE CODE WAS GENERATED DUE TO A FAULT WITH THE OXYGEN BLENDER MODULE'S O2 SENSOR. THE O2 SENSOR IS USED TO MONITOR THE OXYGEN LEVEL INSIDE THE OXYGEN BLENDING MODULE. THE DEVICE'S OXYGEN BLENDING MODULE WAS REPLACED TO ADDRESS THE ISSUE. THIS TYPE OF FAILURE WOULD NOT AFFECT THE ABILITY OF THE DEVICE TO PROVIDE THERAPY TO PUBLISHED SPECIFICATIONS. THE DEVICE WAS TESTED AND PASSED ALL FINAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24298946 ↗
• MalfunctionFeb 3, 2026Circuit Failure; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A TRILOGY 202 VENTILATOR EXPERIENCED A VENTILATOR SERVICE REQUIRED ALARM RELATING TO AN OXYGEN BLENDING MODULE (OBM) FAILURE DURING PREVENTATIVE MAINTENANCE. IT IS ADDITIONALLY NOTED THAT THERE IS PORT DAMAGE AND THE RUBBER FEET ARE MISSING. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. THE TRILOGY 202 VENTILATOR WAS RETURNED AND EVALUATED BY A THIRD PARTY SERVICE CENTER, AND THE FAILURE WAS CONFIRMED. THE SERVICE TECHNICIAN STATES THAT THE FAILURE INDICATES AN OBM PRINTED CIRCUIT ASSEMBLY (PCA) BOARD FAILURE OCCURRED. THE SERVICE TECHNICIAN REPLACED THE OBM PCA BOARD TO RESOLVE THE ISSUE. ADDITIONALLY, IT IS NOTED THAT THE EXHALATION PORT WAS CONFIRMED TO BE DEFECTIVE DUE TO DAMAGE. THE EXHALATION PORT WAS REPLACED. THE POLLEN FILTER WAS REPLACED FOR MAINTENANCE. THE DEVICE PASSED ALL REPAIR TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24246199 ↗
• MalfunctionJan 26, 2026Circuit Failure; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATION 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 HAVING PREVENTATIVE MAINTENANCE PERFORMED AT THE MANUFACTURER SERVICE CENTER WHEN THE ERROR CODE, OXYGEN BLENDING MODULE (OBM) ACCURACY URGENT SERVICE (E-0344), WAS OBSERVED ON THE DEVICE. DURING THE EVALUATION IT WAS NOTED THAT THE OBM PRINTED CIRCUIT ASSEMBLY (PCA) HAD CAUSED THE ERROR CODE TO OCCUR 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 MOTOR BLOWER WAS REPLACED FOR THE BLOWER HOUR BEING TOO HIGH, WHICH WAS UNRELATED TO THE REPORTABLE ISSUE. THE INTERFACE PCA WAS REPLACED TO ADDRESS ANOTHER ERROR CODE, URGENT REMINDER (E0290), THAT WAS FOUND ON THE DEVICE'S ERROR LOG. THIS ERROR CODE WAS UNRELATED TO THE REPORTABLE ISSUE. THE DEVICE PASSED ALL FINAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24183440 ↗
• MalfunctionDec 29, 2025Circuit Failure; Circuit Failure

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR PREVENTATIVE MAINTENANCE. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. NO PATIENT HARM OR INJURY WAS REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, A "VENTILATOR SERVICE REQUIRED" CONCERNING THE SYSTEM OBM (OXYGEN BLENDING MODULE) WAS FOUND. THE OBM BOARD WAS REPLACED TO ADDRESS THE ISSUE. THE DEVICE PASSED ALL FINAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23908921 ↗
• MalfunctionDec 5, 2025Circuit Failure; Battery Problem; Circuit Failure; Battery Problem

  THE MANUFACTURER RECEIVED INFORMATION THAT AN TRILOGY 202 VENTILATOR WAS EVALUATED BY THE MANUFACTURER'S SERVICE CENTER FOR THE COMPLAINT OF AN ERROR CODE. THERE WAS NO HARM OR INJURY REPORTED. UPON INSPECTING THE ERROR LOGS OF THE DEVICE, URGENT CODE E-344 WAS DISCOVERED, INDICATING AN OXYGEN BLENDING MODULE PCA BOARD FAILURE. IN ORDER TO ADDRESS THIS CODE, THE CORRESPONDING BOARD AND GASKET WERE REPLACED, AND THE REPAIR TEST WAS CONDUCTED. DURING THE FINAL STEPS OF THE REPAIR TEST, IT WAS DISCOVERED THAT THE INTERNAL BATTERY WAS ALSO NOT PROPERLY HOLDING CHARGE. TO ADDRESS THIS ISSUE, THE INTERNAL BATTERY WAS REPLACED, AND THE TEST WAS RESTARTED WHICH THEN RESULTED IN A PASS. THE DEVICE PASSED FINAL TESTING AFTER REPAIR AND WAS DETERMINED TO OPERATE PROPERLY. THE SYSTEM MEETS THE SPECIFICATION FOR THE PERFORMED SERVICE AND IS RETURNED TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23726822 ↗
• MalfunctionDec 3, 2025Circuit Failure; Circuit Failure

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THAT DURING SERVICE OF DEVICE BY CUSTOMER, AN ERROR CODE RELATED TO THE OXYGEN BLENDING MODULE WAS FOUND IN THE ERROR LOG. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. ERR_OBM_ACCY_URGENT_SERVICE IS POTENTIALLY A FAILURE OF THE OXYGEN BLENDING MODULE, WHICH MAY IMPACT THERAPY (DELIVERY OF O2). THE OXYGEN BLENDING MODULE BOARD WAS REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, AN URGENT REMINDER ERROR CODE WAS FOUND IN THE ERROR LOG. THIS IS A NOTIFICATION TO THE USER THAT ONE OR MORE ¿VENTILATOR SERVICE REQUIRED¿ ERRORS ARE ACTIVE IN THE SYSTEM. THIS IS INFORMATIONAL AND NO REPLACEMENT PARTS ARE NECESSARY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23707757 ↗
• MalfunctionNov 25, 2025Circuit Failure; Electrical /Electronic Property Problem; Circuit Failure; Electrical /Electronic Property Problem

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS NOT REPORTED TO BE IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE CUSTOMER'S COMPLAINT WAS CONFIRMED. A "SERVICE REQUIRED" ERROR CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED EVENT LOG. THE DEVICE'S OXYGEN BLENDER CIRCUIT BOARD WAS REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, THE DEVICES BLOWER HOURS WERE ALSO FOUND TO BE TOO HIGH, THE MICRON FILTER LOCATED INSIDE TO BE INCORRECT, THE AUDIO PAUSE BUTTON TO BE NON-FUNCTIONAL, AND MISSING RUBBER FEET. TO ADDRESS THESE ISSUES, THE MOTOR BLOWER, MICRON FILTER WITH TUBING, FRONT ENCLOSURE BUTTONS, AND RUBBER FEET WERE ALL REPLACED. THE REPAIR/CALIBRATION TEST THAT FOLLOWED WAS PERFORMED AND SUCCESSFULLY PASSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23649401 ↗
• MalfunctionAug 25, 2025Circuit Failure; Circuit Failure

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING DURING PREVENTIVE MAINTENANCE, AN ERROR CODE RELATED TO THE OXYGEN BLENDING MODULE WAS DISCOVERED IN THE LOG FILE. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE'S OXYGEN BLENDING MODULE BOARD WAS REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, A GENERIC URGENT REMINDER ERROR CODE WAS DISCOVERED IN THE LOG FILE. THIS ERROR CODE IS INFORMATIONAL. IT IS A NOTIFICATION TO THE USER THAT THERE IS A VENTILATOR SERVICE REQUIRED ERROR ACTIVE, AND NO SPECIFIC REPLACEMENT PARTS ARE REQUIRED FOR THIS ERROR MESSAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22885229 ↗
• MalfunctionJun 4, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE TRILOGY 202 WAS NOT WORKING AND ALLEGED THE OXYGEN BLENDING MODULE (OBM) PRINTED CIRCUIT ASSEMBLY (PCA) BOARD HAD FAILED AND NEEDS REPLACING ON THE DEVICE. THERE WAS NO HARM OR INJURY REPORTED. THE CUSTOMER PLACED A SERVICE CALL TO THE LOCAL PHILIPS HELPDESK FOR THIS ISSUE. 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 22145482 ↗
• MalfunctionJun 4, 2025Circuit Failure; Electrical /Electronic Property Problem; Circuit Failure; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE TRILOGY 202 WAS NOT WORKING AND ALLEGED THE OXYGEN BLENDING MODULE (OBM) PRINTED CIRCUIT ASSEMBLY (PCA) BOARD HAD FAILED AND NEEDS REPLACING ON THE DEVICE. THERE WAS NO HARM OR INJURY REPORTED. THE CUSTOMER PLACED A SERVICE CALL TO THE LOCAL PHILIPS HELPDESK FOR THIS ISSUE. 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 22143576 ↗
• MalfunctionJun 4, 2025Circuit Failure; Electrical /Electronic Property Problem; Circuit Failure; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE TRILOGY 202 WAS NOT WORKING AND ALLEGED THE OXYGEN BLENDING MODULE (OBM) PRINTED CIRCUIT ASSEMBLY (PCA) BOARD HAD FAILED AND NEEDS REPLACING ON THE DEVICE. THERE WAS NO HARM OR INJURY REPORTED. THE CUSTOMER PLACED A SERVICE CALL TO THE LOCAL PHILIPS HELPDESK FOR THIS ISSUE. 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 22143570 ↗
• MalfunctionMay 16, 2025Circuit Failure; Circuit Failure

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR SERVICE REQUIRED ALARM OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. THE VENTILATOR WAS EVALUATED BY A FIELD SERVICE ENGINEER AND THE CUSTOMER¿S COMPLAINT WAS CONFIRMED. THE DEVICE'S OXYGEN BLENDING MODULE BOARD WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22033948 ↗
• MalfunctionMar 31, 2025Circuit Failure; Circuit Failure

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR ROUTINE PREVENTATIVE MAINTENANCE. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, A "SERVICE REQUIRED" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S OXYGEN BLENDING MODULE BOARD WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21730026 ↗
• MalfunctionMar 26, 2025Circuit Failure; Electrical /Electronic Property Problem; Circuit Failure; Electrical /Electronic Property Problem

  A CUSTOMER WAS PERFORMING PREVENTATIVE MAINTENANCE ON A TRILOGY 202 VENTILATOR AND A VENTILATOR SERVICE REQUIRED CODE WAS FOUND RELATED TO A POTENTIAL FAILURE TO THE OXYGEN BLENDING MODULE. THE CUSTOMER REQUESTED MANUFACTURER REMOTE SERVICING. THERE WAS NO REPORTED PATIENT INVOLVEMENT. ADDITIONALLY, A VENTILATOR SERVICE REQUIRED REMINDER ERROR CODE WAS FOUND AND THE SERIAL PORT HAS LIQUID DAMAGE. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. THE MANUFACTURER'S REMOTE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21702790 ↗
• MalfunctionMar 5, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR MAY NEED SERVICE AND HAS NOT STARTED IN A WHILE. 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 SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21525871 ↗
• MalfunctionMar 4, 2025Unexpected Shutdown; Unexpected Shutdown

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED. 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 21519277 ↗
• MalfunctionMar 4, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  A VENTILATOR IS RETURNING TO THE MANUFACTURER FOR PREVENTIVE MAINTENANCE. THERE WAS NO HARM OR INJURY REPORTED. THE CUSTOMER INDICATED THE DEVICE WAS ALARMING FOR A SERVICE REQUIRED ALARM CONDITION INDICATING AN OXYGEN BLENDING MODULE BOARD ISSUE. ADDITIONALLY, THE BLOWER HOURS WERE HIGH, AND THERE WAS LIQUID INGRESS IN THE INTERFACE BOARD. THE DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. 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 21517805 ↗
• MalfunctionMar 4, 2025No Display/Image; Electrical /Electronic Property Problem; No Display/Image; Electrical /Electronic Property Problem

  A VENTILATOR IS RETURNING TO THE MANUFACTURER FOR PREVENTIVE MAINTENANCE. THERE WAS NO HARM OR INJURY REPORTED. THE CUSTOMER INDICATED THE DEVICE'S DISPLAY WAS BLANK, THE BLOWER HOURS WERE HIGH, AND THERE WAS LIQUID INGRESS IN THE INTERFACE BOARD. THE DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. 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 21517799 ↗
• MalfunctionFeb 24, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  A TRILOGY 202 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 PRINTED CIRCUIT ASSEMBLY BOARD WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21446488 ↗
• MalfunctionJan 17, 2025Circuit Failure; Electrical /Electronic Property Problem; Circuit Failure; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR WAS ALARMING FOR A "SERVICE REQUIRED" ALARM CONDITION INDICATING A POSSIBLE OXYGEN BLENDING MODULE BOARD ISSUE. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE EVALUATION HAS NOT YET BEEN COMPLETED. 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 21182160 ↗

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