Trilogy O2Recalls & reported problems across all models

We found 2 models of Trilogy O2 by Respironics, Inc. in the FDA's device registry (GUDID). Together they are named in 82 adverse event reports in the FDA's MAUDE database, received between Oct 5, 2016 and Dec 15, 2025 — classified as 2 injuries, 80 malfunctions.

The most frequently reported specific device problem is “Incorrect Or Inadequate Test Results” (26 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 O2 problems

Trilogy O2 models

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

• Trilogy O2 Trilogy O2 Ventilator, Japan, Rental

  Oximeter
  81 reports
• Trilogy O2 Trilogy O2 Ventilator, w/ Bluetooth, Japan

  Oximeter
  1 report

Recent Trilogy O2 adverse event reports

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

• MalfunctionDec 15, 2025Circuit Failure; Electrical /Electronic Property Problem; Circuit Failure; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED A REPORT REGARDING A ¿VENTILATOR SERVICE REQUIRED¿ ALARM ON A TRILOGY VENTILATOR. NO PATIENT HARM OR INJURY WAS REPORTED OR ALLEGED IN CONNECTION WITH THIS EVENT. THE VENTILATOR WAS RETURNED TO THE MANUFACTURER¿S SERVICE CENTER FOR EVALUATION. DURING AN OPERATIONAL CHECK, THE REPORTED ISSUE WAS CONFIRMED. REVIEW OF THE DEVICE LOG FILES IDENTIFIED AN ERROR INDICATING LOSS OF COMMUNICATION BETWEEN THE HOST CONTROLLER AND THE OXYGEN BLENDING MODULE (OBM). FURTHER INVESTIGATION DETERMINED THAT REPLACEMENT OF THE INTERFACE PRINTED CIRCUIT ASSEMBLY (PCA) AND OXYGEN BLENDER PRINTED CIRCUIT ASSEMBLY (PCA) WAS REQUIRED. FOLLOWING REPLACEMENT OF THE IDENTIFIED COMPONENTS, THE SERVICE TECHNICIAN PERFORMED POST-REPAIR VERIFICATION TESTING, INCLUDING ALARM VERIFICATION, BATTERY TESTING, RUN-IN TESTING, AND CLEANING. THE VENTILATOR WAS CONFIRMED TO BE OPERATING WITHIN SPECIFICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23804373 ↗
• MalfunctionJul 11, 2025Circuit Failure; Circuit Failure

  THE MANUFACTURER RECIEVED AN ALLEGATION OF AN ERROR INDICATING A FAILURE IN THE OXYGEN BLENDING MODULE. 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 22487902 ↗
• MalfunctionJun 26, 2025Circuit Failure; Circuit Failure

  A TRILOGY O2 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 "VENTILATOR SERVICE REQUIRED" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG INDICATING AN OXYGEN BLENDING MODULE ACCURACY URGENT SERVICE ISSUE. THIS ERROR CODE WAS NO REPRODUCED DURING OPERATIONAL TESTING OF THE VENTILATOR. ALTHOUGH THE ISSUE WAS NOT DUPLICATED DURING DEVICE EVALUATION, THE DEVICE'S OXYGEN BLENDING MODULE PRINTED CIRCUIT BOARD ASSEMBLY WAS REPLACED AS A PREVENTATIVE MEASURE. PREVENTATIVE MAINTENANCE WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22338224 ↗
• MalfunctionMay 23, 2025Battery Problem; Battery Problem

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR ROUTINE PREVENTATIVE MAINTENANCE ON A TRILOGY O2 DEVICE. 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 MANUFACTURER'S SERVICE TECHNICIAN REPLACED THE DEVICE'S POWER MANAGEMENT PRINTED CIRCUIT ASSEMBLY BOARD TO ADDRESS THE ISSUE. ADDITIONAL FINDINGS NOT RELATED TO THE MALFUNCTION/ISSUE WAS THE FOLLOWING PARTS BEING PROACTIVELY REPLACED ON THE DEVICE: O2 PREVENTATIVE MAINTENANCE KIT, EXHAUST FAN ASSEMBLY, AND FORTY-THREE MICRON FILTER. AFTER ALL THE PARTS WERE REPLACED ON THE DEVICE, THE MANUFACTURER'S SERVICE TECHNICIAN PERFORMED THE REPAIR AND RUN-IN TESTS, ALONG WITH THE BATTERY AND ALARM CHECKS. THE MANUFACTURER'S SERVICE TECHNICIAN DETERMINED THE DEVICE WAS OPERATIONAL AND IT WAS CLEANED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22079015 ↗
• MalfunctionMay 8, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR SERVICE REQUIRED ALARM HAD GONE OFF ON A TRILOGY O2 DEVICE. THE DEVICE WAS REPLACED BY ANOTHER DEVICE. 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 21989090 ↗
• MalfunctionApr 28, 2023Circuit 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, A "SERVICE REQUIRED" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S OXYGEN BLENDING MODULE BOARD AND INTERFACE BOARD NEEDS TO BE REPLACED TO ADDRESS THE ISSUE. THE UNIT WILL NEED TO BE SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16831940 ↗
• MalfunctionDec 21, 2021Circuit 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, 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 13051575 ↗
• MalfunctionApr 29, 2019Failure to Charge; Failure to Charge

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

  Patient problems: No Patient Involvement

  MAUDE report 8560465 ↗
• MalfunctionMar 13, 2019Circuit Failure; Failure to Recalibrate; Circuit 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. THE DEVICE'S OXYGEN BLENDING MODULE BOARD WAS REPLACED TO ADDRESS THE ISSUE. DURING EVALUATION, THE DEVICE FAILED STEPS DURING TESTING. THE DEVICE'S SENSOR BOARD WAS REPLACED TO ADDRESS THE ISSUES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8416611 ↗
• MalfunctionDec 21, 2018Mechanical Problem; Mechanical Problem

  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 DEVICE'S NAVIGATIONAL BUTTON WAS OBSERVED. THE DEVICE'S FRONT PANEL/KEYPAD LED BOARD WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 8190670 ↗
• MalfunctionDec 13, 2018Circuit 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 Patient Involvement

  MAUDE report 8161555 ↗
• MalfunctionDec 13, 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 OXYGEN BLENDING MODULE BOARD WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 8161515 ↗
• MalfunctionNov 13, 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 A TEST STEP DURING TESTING. THE DEVICE'S SENSOR BOARD WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 8063885 ↗
• MalfunctionNov 13, 2018Circuit 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 Patient Involvement

  MAUDE report 8063874 ↗
• MalfunctionNov 13, 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 A TEST STEP DURING TESTING. THE DEVICE'S SYSTEM BOARD WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 8063864 ↗

Other Respironics, Inc. products

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