Trilogy 200 Trilogy200, Aeris 200, BluetoothRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00606959027763), received between Jul 20, 2016 and May 27, 2026 — classified as 2 deaths, 15 malfunctions.

The most frequently reported specific device problem is “Circuit Failure” (7 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2026Electrical /Electronic Property Problem; Mechanical Problem

  A TRILOGY 200 WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR PREVENTIVE MAINTENANCE AND CALIBRATION. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS NOT IN PATIENT USE. DURING THE INITIAL EVALUATION A VENTILATOR INOPERATIVE ALARM WAS OBSERVED. THE EVALUATION HAS NOT YET BEEN COMPLETED. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. IF ANY ADDITIONAL INFORMATION IS RECEIVED ONCE THE INVESTIGATION IS COMPLETE, A FOLLOW-UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25303403 ↗
• MalfunctionApr 13, 2026Circuit Failure

  A DEVICE WAS RETURNED TO A 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 REPORT OF PATIENT HARM OR INJURY. A TRILOGY 200 VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR FOAM REMEDIATION ON THE DEVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THERE WERE NO FOAM PARTICLES FOUND IN THE DEVICE. THE DEVICE FAILED FUNCTIONAL TESTING RELATING TO THE DP PURGE VALVE TEST STEP. THE SERVICE TECHNICIAN STATES THAT THE TRILOGY 200/202/O2 SENSOR PRINTED CIRCUIT ASSEMBLY (PCA) BOARD WAS REPLACED TO RESOLVE THE ISSUE. THE DEVICE PASSED FINAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24865350 ↗
• MalfunctionApr 7, 2026Mechanical Problem; Calibration Problem

  A DEVICE WAS RETURNED TO A 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 REPORT OF PATIENT HARM OR INJURY. A TRILOGY 200 VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR FOAM REMEDIATION ON THE DEVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THERE WERE NO FOAM PARTICLES FOUND IN THE DEVICE. THE DEVICE FAILED FUNCTIONAL TESTING RELATING TO THE ACTIVE EXHALATION PROPORTIONAL VALVE OPEN AND PURGE VALVE TEST STEPS. THE SERVICE TECHNICIAN STATES THAT THE ACTIVE EXHALATION CONTROL MODULE VALVE WAS REPLACED TO RESOLVE THE ISSUE. THE DEVICE PASSED FINAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24802041 ↗
• MalfunctionApr 7, 2026Mechanical Problem; Calibration Problem

  A DEVICE WAS RETURNED TO A 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 REPORT OF PATIENT HARM OR INJURY. A TRILOGY 200 VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR FOAM REMEDIATION ON THE DEVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THERE WERE NO FOAM PARTICLES FOUND IN THE DEVICE. THE DEVICE FAILED FUNCTIONAL TESTING RELATING TO THE ACTIVE EXHALATION PURGE VALVE CLOSED AND PURGE VALVE TEST STEPS. THE SERVICE TECHNICIAN STATES THAT THE TRILOGY ACTIVE EXHALATION CONTROL MODULE VALVE WAS REPLACED TO RESOLVE THE ISSUE. THE DEVICE PASSED FINAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24802034 ↗
• MalfunctionMar 26, 2026Electrical /Electronic Property Problem

  A DEVICE WAS RETURNED TO A 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 REPORT OF PATIENT HARM OR INJURY. A TRILOGY 200 VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR FOAM REMEDIATION ON THE DEVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THERE WERE NO FOAM PARTICLES FOUND IN THE DEVICE. THE SERVICE TECHNICIAN STATES THAT DEVICE EXPERIENCED A VENTILATOR INOPERATIVE CONDITION AND THAT IT WAS RETEST AND WORKED PROPERLY. THERE IS NO DOCUMENTATION STATED ON A ROOT CAUSE OR ANY COMPONENT REPLACEMENT. THE DEVICE PASSED FINAL TESTING. THE CAPA PROCESS IDENTIFIED COMPLAINTS NOT BEING CREATED FOR QUALITY ISSUES FOUND DURING THIRD PARTY SERVICING. BASED ON A REVIEW OF RECORDS IMPACTED BY THE IDENTIFIED ISSUE, IT WAS DETERMINED THAT THIS RECORD NEEDED TO BE CORRECTED AND IS NOW BEING SUBMITTED ACCORDINGLY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24702336 ↗
• MalfunctionOct 2, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE HAS NOT YET 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 20351888 ↗
• DeathMay 3, 2024Degraded; Degraded

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE ALLEGATION THE PATIENT WENT TO THE HOSPITAL FOR COVID, AND THEN HE RETURNED AT HOME WITH O2 (OXYGEN) PRESCRIPTION DURING THE DAY AND THE VENTILATOR DURING THE NIGHT. THE PATIENT CONDITIONS DECREASED; A FILTER WAS ADDED TO THE VENTILATOR. THE PATIENT WENT IN A COMA DUE A SURPLUS OF CO2 (CARBON DIOXIDE). THE PATIENT DIED IN THE SAME MONTH. THE MANUFACTURER WAS MADE AWARE OF THIS COMPLAINT THROUGH A REPRESENTATIVE OF THE CUSTOMER. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE REQUESTED AT THIS TIME. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

  Patient problems: Unspecified Respiratory Problem; Viral Infection

  MAUDE report 19237358 ↗
• DeathOct 20, 2023Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE MANUFACTURER RECEIVED INFORMATION ALLEGING "THE PATIENT WENT TO THE HOSPITAL FOR COVID, AND THEN HE RETURNED AT HOME WITH O2 (OXYGEN) PRESCRIPTION DURING THE DAY AND THE VENTILATOR DURING THE NIGHT. THE PATIENT CONDITIONS DECREASED; A FILTER WAS ADDED TO THE VENTILATOR. THE PATIENT WENT INTO A COMA DUE TO A SURPLUS OF CO2 (CARBON DIOXIDE). THE PATIENT DIED IN THE SAME MONTH". THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Unspecified Respiratory Problem; Viral Infection

  MAUDE report 17977075 ↗
• MalfunctionOct 28, 2021Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A VENTILATOR'S SOUND ABATEMENT FOAM. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. 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 12711936 ↗
• MalfunctionMay 2, 2019Circuit Failure; Circuit Failure

  A VENTILATOR WAS RETURNED TO THE MANUFACTURE FOR SERVICE. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, AN ISSUE RELATED TO THE DEVICE'S FRONT PANEL BOARD WAS OBSERVED. THE DEVICE'S FRONT PANEL/KEYPAD LED PCA WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 8574397 ↗
• MalfunctionMar 20, 2019No Display/Image; No Display/Image

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR'S LCD SCREEN WAS DARK. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE CUSTOMER'S COMPLAINT WAS CONFIRMED. THE DEVICE'S LCD SCREEN WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 8437465 ↗
• MalfunctionMar 20, 2019Circuit Failure; Circuit Failure

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, A "VENTILATOR INOPERATIVE" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S SYSTEM BOARD WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 8435852 ↗
• MalfunctionMar 20, 2019Circuit Failure; Circuit Failure

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, A "VENTILATOR INOPERATIVE" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S SYSTEM BOARD WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 8435850 ↗
• MalfunctionMar 20, 2019Circuit Failure; Circuit Failure

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, A FAILURE OF THE DEVICE'S KEYPAD WAS OBSERVED. THE DEVICE'S FRONT PANEL/KEYPAD LED PCA WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 8435843 ↗
• MalfunctionOct 24, 2018Circuit Failure; Circuit Failure

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED. THE DEVICE WAS NOT IN PATIENT USE. THE VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND THE CUSTOMER'S COMPLAINT WAS CONFIRMED. THE DEVICE'S SYSTEM BOARD WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 7999476 ↗
• MalfunctionAug 1, 2018Circuit Failure; Circuit Failure

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, A "VENTILATOR INOPERATIVE" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S SYSTEM BOARD WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 7738541 ↗
• MalfunctionJul 20, 2016Device Operational Issue; Device Operational Issue

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. 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 SENSOR BOARD WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 5808852 ↗

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