Trilogy O2 Trilogy O2 Ventilator, Japan, RentalRecalls & reported problems

Summary

The FDA's MAUDE database contains 81 adverse event reports that list this exact device (DI 00606959033887), received between Oct 5, 2016 and Dec 15, 2025 — classified as 2 injuries, 79 malfunctions.

The most frequently reported specific device problem is “Incorrect Or Inadequate Test Results” (26 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 81 reports, 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 ↗
• 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 ↗
• MalfunctionOct 17, 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 TEST STEPS DURING TESTING. THE DEVICE'S OXYGEN BLENDING MODULE BOARD WAS REPLACED TO ADDRESS THE ISSUES.

  Patient problems: No Patient Involvement

  MAUDE report 7973330 ↗
• MalfunctionOct 3, 2018Circuit Failure; Incorrect, Inadequate or Imprecise Result or Readings; Circuit Failure; Incorrect, Inadequate or Imprecise Result or Readings

  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 OXYGEN BLENDING MODULE BOARD WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 7929555 ↗
• MalfunctionSep 5, 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 AND INTERFACE BOARD WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 7846242 ↗
• MalfunctionAug 29, 2018Mechanical Problem; Mechanical 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, A FAILURE OF THE DEVICE'S NAVIGATION BUTTONS WAS OBSERVED. THE DEVICE'S FRONT PANEL/LED BOARD WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 7826376 ↗
• MalfunctionAug 15, 2018Circuit Failure; Circuit Failure

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A "SERVICE REQUIRED" ALARM CONDITION OCCURRED. 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 Consequences Or Impact To Patient

  MAUDE report 7784400 ↗
• MalfunctionJul 17, 2018False Alarm; Circuit Failure; False Alarm; Circuit Failure

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR WAS ALARMING FOR AN INTERNAL BATTERY DEPLETED CONDITION. 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 7694144 ↗
• MalfunctionJul 17, 2018Circuit Failure; Contamination; Failure to Recalibrate; Circuit Failure; Contamination; Failure to Recalibrate

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR WAS ALARMING RELATED TO A LOW OXYGEN FLOW CONDITION. THERE WAS NO HARM OR INJURY REPORTED. THE VENTILATOR WAS RETURNED TO THE MANUFACTURER'S SERVICE CENTER FOR EVALUATION AND THE CUSTOMER'S COMPLAINT WAS CONFIRMED. DURING EVALUATION, A "SERVICE REQUIRED" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG AND THE DEVICE FAILED A TEST STEP DUE TO CONTAMINATED FROM A FOREIGN SUBSTANCE. THE DEVICE'S OXYGEN BLENDING MODULE BOARD AND OXYGEN BLENDING MODULE FLOW ELEMENT WERE REPLACED TO ADDRESS THE ISSUES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7693694 ↗
• MalfunctionJul 11, 2018Circuit Failure; Circuit Failure

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR WAS ALARMING FOR AN INTERNAL BATTERY DEPLETED CONDITION. 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 7677580 ↗
• MalfunctionJul 11, 2018Circuit Failure; Circuit Failure

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A "SERVICE REQUIRED" ALARM CONDITION OCCURRED. 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 Consequences Or Impact To Patient

  MAUDE report 7677492 ↗
• MalfunctionJul 3, 2018Device Inoperable; Device Displays Incorrect Message; Device Inoperable; Device Displays Incorrect Message

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED. 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 SYSTEM BOARD NEEDS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7659236 ↗
• MalfunctionMay 16, 2018Device Operational Issue; Device Operational Issue

  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 SYSTEM BOARD WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7518101 ↗

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