Trilogy 200 Trilogy 200 Ventilator, Japan-RentalRecalls & reported problems

Summary

The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 00606959033863), received between Sep 26, 2016 and Aug 31, 2026 — classified as 2 deaths, 54 malfunctions.

The most frequently reported specific device problem is “Incorrect Or Inadequate Test Results” (18 reports).

5 other recalls cover devices cleared under the same FDA submission (K093416); 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 56 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 31, 2026Electrical /Electronic Property Problem; Battery Problem

  A Trilogy 200 ventilator was returned to the third-party service center in reference to the voluntary Field Safety Notice / recall notification related to the sound abatement foam in certain CPAP, BiPAP, and mechanical ventilator devices. There was no allegation of serious or permanent harm or injury. During the evaluation of the device at a third-party service center, the device was visually inspected and found no evidence of foam degradation. However, an error code indicating a BATT_LOW_STATE_OF_HEALTH_INT_LI_ION Failure occurred was observed in the device event log. No repairs were performed and the device will be scrapped.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50525178 ↗
• MalfunctionJun 10, 2024Electrical /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. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, AN "INTERNAL BATTERY" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S POWER MANAGEMENT BOARD WAS REPLACED TO ADDRESS THE ISSUE. ADDITIONAL FINDINGS NOT RELATED TO THE MALFUNCTION/ISSUE WERE THE DETACHABLE BATTERY, POLLEN FILTER, EXHAUST FAN ASSEMBLY, 43-MICRON FILTER WERE PROACTIVELY REPLACED ON THE DEVICE. AFTER REPLACING THE PARTS ON THE SYSTEM, THE REPAIR TEST AND RUNNING TEST, BATTERY AND VALVE CHECKS, AND A CLEANING OF THE DEVICE WERE PERFORMED. THE DEVICE WAS FOUND TO BE OPERATIONAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19502839 ↗
• MalfunctionMar 7, 2022Degraded; Degraded

  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 BLOWER AND STIRRING FAN FOAM KIT WERE REPLACED. 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 13685191 ↗
• MalfunctionMar 1, 2022Degraded; Degraded

  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 AIR INLET PATH ASSEMBLY WAS REPLACED DUE TO SPONGE PEELED OFF AND POLLEN FILTER AND AIR PATH FOAM WERE REPLACED. 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 13634055 ↗
• MalfunctionMar 20, 2019Leak/Splash; Leak/Splash

  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 LEAK WAS OBSERVED FROM THE DEVICE'S EXHALATION PORT. THE DEVICE'S ACTIVE EXHALATION CONTROL MODULE WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 8435842 ↗
• MalfunctionNov 5, 2018Failure to Recalibrate; Failure to Recalibrate

  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 TEST STEPS DURING TESTING. THE DEVICE'S ACTIVE EXHALATION CONTROL MODULE WAS REPLACED TO ADDRESS THE ISSUES.

  Patient problems: No Patient Involvement

  MAUDE report 8037379 ↗
• MalfunctionOct 19, 2018Circuit Failure; Circuit Failure

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR "SERVICE REQUIRED" ALARM CONDITION OCCURRED. THE DEVICE WAS NOT IN PATIENT USE. DURING EVALUATION, A "SERVICE REQUIRED" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S SENSOR BOARD WAS REPLACED TO ADDRESS THE ISSUE. THE SENSOR BOARD WAS RETURNED TO THE MANUFACTURER'S QUALITY ASSURANCE LABORATORY FOR FURTHER INVESTIGATION. DURING THE INVESTIGATION, THE ROOT CAUSE OF THE SENSOR BOARD FAILURE WAS RELATED TO A SENSOR DRIFT.

  Patient problems: No Patient Involvement

  MAUDE report 7984789 ↗
• MalfunctionSep 12, 2018Mechanical Problem; Mechanical Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR'S ACTIVE EXHALATION CONTROL MODULE FAILED TO OPEN OR CLOSE CORRECTLY. THERE WAS NO HARM OR INJURY REPORTED. THE VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND THE CUSTOMER'S COMPLAINT WAS CONFIRMED. THE DEVICE'S ACTIVE EXHALATION CONTROL MODULE WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7868164 ↗
• MalfunctionSep 5, 2018Failure to Recalibrate; Failure to Recalibrate

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR ROUTINE PREVENTIVE 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 STEP DURING TESTING. THE DEVICE'S ACTIVE EXHALATION CONTROL MODULE WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 7845985 ↗
• MalfunctionSep 5, 2018Circuit Failure; Circuit 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, AN ERROR CODE RELATED TO THE CHARGING OF THE INTERNAL BATTERY WAS OBSERVED. THE DEVICE'S POWER MANAGEMENT BOARD WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7845963 ↗
• MalfunctionAug 20, 2018Failure to Recalibrate; Failure to Recalibrate

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR ROUTINE PREVENTIVE 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 STEP DURING TESTING. THE DEVICE WAS RECALIBRATED TO ADDRESS THE ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 7798768 ↗
• MalfunctionAug 1, 2018Circuit Failure; Circuit Failure

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR ROUTINE PREVENTIVE 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, AN "INTERNAL BATTERY DEPLETED" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S POWER MANAGEMENT BOARD WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 7738545 ↗
• MalfunctionJul 17, 2018Circuit Failure; Circuit Failure

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR ROUTINE PREVENTIVE 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 POWER MANAGEMENT BOARD WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 7693687 ↗
• MalfunctionMay 30, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  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 RELATED TO THE SENSOR BOARD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7552624 ↗
• MalfunctionMay 16, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR ROUTINE PREVENTIVE 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 STEP DURING TESTING. THE DEVICE'S SENSOR BOARD WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 7518113 ↗
• MalfunctionApr 24, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR ROUTINE PREVENTIVE 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 TEST STEPS DURING TESTING. THE DEVICE'S ACTIVE EXHALATION CONTROL MODULE WAS REPLACED TO ADDRESS THE ISSUES.

  Patient problems: No Patient Involvement

  MAUDE report 7454062 ↗
• MalfunctionMar 14, 2018Device Operational Issue; Device Operational Issue

  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, AN ERROR CODE RELATED TO THE CHARGING OF THE INTERNAL BATTERY WAS OBSERVED. THE DEVICE WAS RECALIBRATED TO ADDRESS THE ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 7337460 ↗
• MalfunctionJan 11, 2018Device Operational Issue; Device Operational Issue

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR ROUTINE PREVENTIVE 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, AN ISSUE RELATED TO THE ACTIVE EXHALATION CONTROL MODULE WAS OBSERVED. THE DEVICE'S ACTIVE EXHALATION CONTROL MODULE WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 7181751 ↗
• MalfunctionJan 11, 2018Device Operational Issue; Device Operational Issue

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR ROUTINE PREVENTIVE 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, AN ERROR CODE RELATED TO THE CHARGING OF THE INTERNAL BATTERY WAS OBSERVED. THE DEVICE'S POWER MANAGEMENT BOARD WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 7181737 ↗
• MalfunctionDec 4, 2017Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR ROUTINE PREVENTIVE 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 STEP DURING TESTING. THE DEVICE'S SYSTEM BOARD WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 7079348 ↗
• MalfunctionNov 1, 2017Failure to Charge; Failure to Charge

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR "SERVICE REQUIRED" ALARM CONDITION OCCURRED RELATED TO A FAILURE TO CHARGE INTERNAL BATTERY. THERE WAS NO HARM OR INJURY REPORTED. THE VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND THE CUSTOMER'S COMPLAINT WAS CONFIRMED. THE DEVICE'S POWER MANAGEMENT BOARD WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6993409 ↗
• DeathOct 5, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A PATIENT EXPIRED AFTER BECOMING DISCONNECTED FROM A VENTILATOR. THE REPORTED DAY OF THE EVENT WAS (B)(6) 2017. ACCORDING TO THE REPORTER OF THE EVENT, THE PATIENT'S WIFE CHECKED ON HIM AT APPROXIMATELY 15:00:00 LOCAL TIME ON (B)(6) 2017 AND THEN RETURNED TO WORK. A RELATIVE VISITED THE HOUSE AND FOUND THE PATIENT DISCONNECTED FROM THE VENTILATOR. THE RELATIVE RECONNECTED THE PATIENT AND ATTEMPTED TO CONTACT THE WIFE. THE PATIENT WAS TAKEN TO A HOSPITAL WHERE HE EXPIRED. THE VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE DEVICE PASSED ALL TESTING AND WAS FOUND TO OPERATE AND ALARM AS DESIGNED. THE VENTILATOR'S DOWNLOADED EVENT LOGS WERE REVIEWED. THE DEVICE MAINTAINS THE EVENT LOGS IN NON-VOLATILE MEMORY. AN EVENT, AS LOGGED BY THE DEVICE, INCLUDES EVERY KEYPRESS, ALARM OR FAILURE OF THE DEVICE TO REMAIN WITHIN SPECIFICATIONS. THERE WERE NO EVENTS LOGGED RELATED TO DEVICE PERFORMANCE OR DEVICE MALFUNCTIONS. IF A DEVICE MALFUNCTION OCCURRED, THE EVENT LOGS WOULD HAVE CONTAINED ENTRIES RELATED TO THE MALFUNCTION. ON THE REPORTED DAY OF THE EVENT, (B)(6) 2017, THE VENTILATOR BEGAN ALARMING FOR A LOW PEAK EXPIRATORY PRESSU

  Patient problems: Death

  MAUDE report 6916787 ↗
• MalfunctionSep 27, 2017Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR ROUTINE PREVENTIVE 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 STEP DURING TESTING. THE DEVICE'S ACTIVE EXHALATION CONTROL MODULE WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 6896882 ↗
• MalfunctionAug 28, 2017Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR ROUTINE PREVENTIVE 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 STEPS DURING TESTING. THE DEVICE'S ACTIVE EXHALATION CONTROL MODULE WAS REPLACED TO ADDRESS THE ISSUES.

  Patient problems: No Patient Involvement

  MAUDE report 6824278 ↗
• DeathJun 27, 2017Adverse Event Without Identified Device or Use Problem; Disconnection; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A PATIENT BECAME DISCONNECTED FROM A VENTILATOR. ACCORDING TO THE REPORTER OF THE EVENT, THE VENTILATOR WAS ALARMING FOR A PATIENT CIRCUIT DISCONNECT FOR A SUBSTANTIAL TIME UNTIL THE CAREGIVER ACKNOWLEDGED THE DISCONNECT CONDITION. THE PATIENT WAS MOVED TO AN INTENSIVE CARE UNIT FOLLOWING THE EVENT. THE MANUFACTURER'S INVESTIGATION IS CURRENTLY ON-GOING. A FOLLOW-UP REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.

  Patient problems: Low Oxygen Saturation; No Known Impact Or Consequence To Patient

  MAUDE report 6670119 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K093416. One submission often covers many models, so check the product and lot details in each record.

• Z-0883-2023 · Dec 7, 2022 · Open, Classified
  Philips Trilogy 200 Ventilator, Model Numbers 1040005, U1040005, 1040005B, U1040005B, CA1032800B, CA1032800, KO1032800, 1032800, R1032804TP, R1032804B, R1032804TPV, 1032804B
• 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