Trilogy 200Recalls & reported problems across all models

We found 8 models of Trilogy 200 by Respironics, Inc. in the FDA's device registry (GUDID). Together they are named in 249 adverse event reports in the FDA's MAUDE database, received between Jul 20, 2016 and Sep 25, 2026 — classified as 5 deaths, 244 malfunctions.

The most frequently reported specific device problem is “Circuit Failure” (33 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Trilogy 200 problems

Trilogy 200 models

8 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Trilogy 200 Trilogy 200 Bluetooth, U.S.A.

  VENTILATOR, CONTINUOUS, FACILITY USE
  92 reports
• Trilogy 200 Trilogy 200 Ventilator, Japan-Rental

  VENTILATOR, CONTINUOUS, FACILITY USE
  2 deaths56 reports
• Trilogy 200 LifeVent200 Ventilator, Sapio, Bluetooth

  Oximeter
  1 death32 reports
• Trilogy 200 Trilogy 200 Ventilator, Bluetooth, Canada

  CONTINUOUS, VENTILATOR, HOME USE
  23 reports
• Trilogy 200 Trilogy200, Aeris 200, Bluetooth

  CONTINUOUS, VENTILATOR, HOME USE
  2 deaths17 reports
• Trilogy 200 Trilogy 200 Ventilator, Italy, Bluetooth

  Medical device data system
  13 reports
• Trilogy 200 Trilogy200, Ventilator, Bluetooth, International

  VENTILATOR, CONTINUOUS, FACILITY USE
  9 reports
• Trilogy 200 Trilogy200 Ventilator, Korea (Philips)

  Oximeter
  7 reports

Recent Trilogy 200 adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Failure to Power Up

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50902455 ↗
• MalfunctionSep 25, 2026Electrical /Electronic Property Problem

  The manufacturer received information alleging a cell undervoltage error code was observed on a Trilogy 100 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, cell undervoltage, was observed on the device's error log. The service technician provided no documentation stated on a root cause and/or any component replacement to resolve the cell undervoltage error code. There was no repair information was provided, and no part(s) were replaced to address this issue. 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 supplemental report will be completed. The root cause isn't confirmed at this time. Additionally, during the service of the device, the rubber feet were replaced for missing on the device. This was unrelated to the reportable issue. The device passed all final testing.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50896040 ↗
• MalfunctionSep 2, 2026Circuit Failure; Failure to Calibrate

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50565630 ↗
• 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 ↗
• MalfunctionJul 1, 2026Mechanical Problem; Failure to Calibrate

  THE TRILOGY 200 VENTILATOR WAS RETURNED TO THE MANUFACTURER SERVICE CENTER FOR PREVENTATIVE MAINTENANCE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. DURING THE EVALUATION IT WAS NOTED THE DEVICE RETURNED TO THE TECHNICIAN FOR ADDITIONAL EVALUATION DUE TO A FAILED ACTIVE EXHALATION PURGE VALVE CLOSED AND ACTIVE EXHALATION PROPORTIONAL VALVE OPEN TEST STEP DURING TESTING. THERE WERE NO SIGNIFICANT EVENT(S) IN THE ERROR LOG(S). ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, THE DEVICE FAILED TESTING FOR INTERNAL BATTERY CAPACITY THEREFORE THE INTERNAL BATTERY NEEDS TO BE REPLACED TO ADDRESS THE ISSUE. ADDITIONAL COMPONENTS REQUIRED REPLACEMENT AS PART OF MAINTENANCE OF THE DEVICE OR DUE TO PHYSICAL/COSMETIC DAMAGE. THE DEVICE WAS SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25676612 ↗
• MalfunctionJun 10, 2026Circuit Failure; Failure to Calibrate; Charging Problem

  A TRILOGY 200 WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION. THERE WAS NO HARM OR INJURY REPORTED. THERE WAS NO EVIDENCE THE DEVICE WAS IN PATIENT USE. DURING THE EVALUATION THE DEVICE FAILED A TEST STEP INDICATING AN INTERNAL BATTERY CHARGE FAILURE. THE DEVICE'S POWER MANAGEMENT BOARD NEEDS TO BE REPLACED TO ADDRESS THE ISSUE. NO COMPONENTS WERE REPLACED. THE DEVICE WAS RETURNED UNREPAIRED AS PER THE CUSTOMER'S REQUEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25460754 ↗
• MalfunctionJun 10, 2026Circuit Failure; Electrical /Electronic Property Problem

  A TRILOGY 200 VENTILATOR DEVICE WAS RETURNED TO A SERVICE CENTER FOR RECERTIFICATION. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. DURING THE EVALUATION, THE SERVICE TECHNICIAN OBSERVED R VENT SERVICE REQUIRED ERROR CODES E201 (ERR_VSUPPLY_FAILURE) AND E202 (ERR_12V_FAILURE) IN THE ERROR LOG. THE SUPPLY VOLTAGE IS OUT OF RANGE FOR 10 SECONDS, DUE TO A POWER MANAGEMENT BOARD FAILURE. THE POWER MAY FAIL. THE SYSTEM AND POWER MANAGEMENT PRINTED CIRCUIT ASSEMBLY (PCA) WILL NEED TO BE REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, THE FEET WERE MISSING, THE CORD RETAINER WAS MISSING, THE WARNING LABEL WAS DAMAGED, THE HANDLE WAS CRACKED, THE PORTING BLOCK WAS CRACKED, THE OVERLAY DISPLAY WAS DAMAGED, AND THE MAC ADDRESS LABEL WAS ILLEGIBLE. THE DEVICE WAS DISQUALIFIED FROM RECERTIFICATION. DEVICE WILL BE SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25460380 ↗
• MalfunctionMay 29, 2026Circuit Failure

  THE MANUFACTURER RECEIVED INFORMATION THAT A TRILOGY 200 WAS RETURNED TO THE MANUFACTURER'S SERVICE CENTER FOR EVALUATION. THERE WAS NO PATIENT INVOLVEMENT, AND NO HARM OR INJURY REPORTED. ON DEVICE EVALUATION, THE DEVICE FAILED REPAIR TESTING DUE TO DIFFERENTIAL PRESSURE (DP) PURGE VALVES V3/V4 OPENED. THE DEVICE WAS RETURNED TO THE TECHNICIAN FOR ADDITIONAL EVALUATION WHERE THE TEST FAILURE WAS CONFIRMED. THE DEVICE PRINTED CIRCUIT BOARD ASSEMBLY REQUIRED REPLACEMENT TO ADDRESS THIS ISSUE. ADDITIONAL FINDINGS NOT RELATED TO THE MALFUNCTION/ISSUE: PREVENTIVE MAINTENANCE WAS COMPLETED WITH REQUIRED COMPONENTS BEING REPLACED PER MAINTENANCE SCHEDULE. DEVICE ERROR CODE E-194 WAS NOTED INDICATING THE DETACHABLE BATTERY FAILED. THE DETACHABLE BATTERY IS AN OPTIONAL ACCESSORY, AND A FAILURE WOULD RESULT IN USE OF THE INTERNAL BATTERY. THE DETACHABLE BATTERY POWER IS USED FIRST, WITH THE INTERNAL BATTERY POWER AS A BACK-UP. THEREFORE, THIS SCENARIO WOULD NOT RESULT IN A LOSS OF THERAPY. MISSING AND/OR DAMAGED DEVICE COMPONENTS WERE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25331870 ↗
• 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 ↗
• MalfunctionMay 26, 2026Computer Software Problem; Failure to Calibrate

  A TRILOGY 200 WAS RETURNED TO THE MANUFACTURER FOR RECERTIFICATION. THERE WAS NO HARM OR INJURY REPORTED. THERE WAS NO EVIDENCE THE DEVICE WAS IN PATIENT USE. DURING THE EVALUATION THERE WERE NO CRITICAL ERRORS OBSERVED IN THE DOWNLOADED EVENT LOG. SEVERAL COMPONENTS WERE REPLACED DUE TO MISSING/PHYSICAL DAMAGE. DURING FINAL TESTING THE DEVICE FAILED A PPROXIMAL PRESSURE VERIFICATION TEST STEP. THE DEVICE'S SENSOR TABLE WAS RECALIBRATED TO ADDRESS THE ISSUE. NO COMPONENTS WERE REPLACED FOR THIS ISSUE. THE DEVICE PASSED ALL FINAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25279199 ↗
• MalfunctionMay 21, 2026Circuit Failure; No Display/Image; Calibration Problem; Intermittent Communication Failure

  THE MANUFACTURER RECEIVED INFORMATION THAT A TRILOGY 200 VENTILATOR DEVICE WAS RETURNED TO A SERVICE CENTER FOR SERVICE. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. DURING THE EVALUATION, THE SERVICE TECHNICIAN OBSERVED THAT THE DEVICE FAILED TESTING FOR LCD SCREEN TEST. THE DEVICE WAS POWERED ON AND LEFT TO OPERATE. AFTER SEVERAL MINUTES, THE SCREEN WENT BLANK AND WAS ILLEGIBLE. IT WAS DETERMINED THAT THE TEST FAILURE WAS CAUSED BY A FAULTY SYSTEM BOARD PRINTED CIRCUIT ASSEMBLY (PCA). THE SYSTEM BOARD PCA WILL NEED TO BE REPLACED DUE TO THE TEST FAILURE. IN ADDITION, THE ENCLOSURE FEET WERE MISSING AND REPLACED, AND THE CAPACITOR AND FRONT CASE OVERLAY WERE REPLACED DUE TO PHYSICAL DAMAGE. THE INTERFACE PCA BOARD HAD A COMMUNICATION ISSUE AND WAS REPLACED, AND THE DETACHABLE BATTERY WILL NEED TO BE REPLACED DUE TO ERROR CODE E194 (ERR_PERM_FAIL_DET_LI_ION). THE DEVICE REPAIR HAD NOT BEEN COMPLETED THE SERVICE CENTER WAS STILL AWAITING PARTS. 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/SUPPLEME

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25246754 ↗
• MalfunctionMay 20, 2026Electrical /Electronic Property Problem; Mechanical Problem

  THE MANUFACTURER RECEIVED INFORMATION THAT A TRILOGY 100 VENTILATOR DEVICE WAS RETURNED TO A SERVICE CENTER FOR SERVICE. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. DURING THE EVALUATION, THE SERVICE TECHNICIAN OBSERVED AN R VENTILATOR INOPERATIVE ERROR CODE E009 (ERR_DSP_MOTOR_FAILURE) IN THE ERROR LOG. THE BLOWER WILL BE REPLACED TO ADDRESS THE ERROR CODE. IN ADDITION, THE CORD RETAINER WAS MISSING AND REPLACED, THE KEYPAD, FRONT CASE, REAR CASE, BASE ENCLOSURE WITH LABELS AND FEET, HANDLE, AND ENCLOSURE TOP PLATE HAVE ALL BEEN REPLACED FOR PHYSICAL DAMAGE. THE PORTING BLOCK ADAPTER KIT HAD A BROKEN SCREW BOSS MOUNT AND WAS REPLACED, THE INTERFACE PCA WAS REPLACED DUE TO A COMMUNICATION FAILURE, AND THE EXHAUST FAN AND TUBING KIT WERE REPLACED DUE TO CONTAMINATION. THE DEVICE PASSED ALL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25233006 ↗
• MalfunctionMay 11, 2026Failure to Calibrate; Infusion or Flow Problem

  A TRILOGY 200 VENTILATOR WAS RETURNED TO THE MANUFACTURER'S SERVICE CENTER FOR SERVICE. NO PATIENT HARM OR INJURY WAS REPORTED. THE DEVICE WAS NOT IN CLINICAL USE. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE TRILOGY 200 VENTILATOR FAILED TESTING FOR "CHECK LEAK: CONTROL FLOW". THE SENSOR BOARD WILL NEED TO BE REPLACED TO ADDRESS THE FAILED TEST. THE REPAIR IS AWAITING CUSTOMER APPROVAL AT THIS TIME. 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 25135089 ↗
• MalfunctionMay 6, 2026Computer Software 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. DURING THE EVALUATION AND FUNCTIONAL TESTING OF THE DEVICE AN ERROR CODE RELATED TO O2 FLOW WAS IDENTIFIED. THE DEVICE WAS TESTED AGAIN AND PASSED TESTING. IN ADDITION, THE DEVICE WAS VISUALLY INSPECTED AND FOUND NO EVIDENCE OF FOAM DEGRADATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25096308 ↗
• MalfunctionMay 4, 2026Computer Software 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 LIFE VENT 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 POSITIVE FLOW TEST STEP. THE SOFTWARE WAS UPGRADED AND THE RUN-IN TESTING WAS REDONE TO ADDRESS THE ISSUE. THE DEVICE PASSED FINAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25068781 ↗

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