Trilogy 00 (REF R1054260)Recalls & reported problems

Summary

The FDA's MAUDE database contains 119 adverse event reports that list this exact device (DI 00606959026308), received between Nov 4, 2015 and May 30, 2025 — classified as 4 deaths, 1 injury, 114 malfunctions.

The most frequently reported specific device problem is “Incorrect Or Inadequate Test Results” (20 reports).

8 other recalls cover devices cleared under the same FDA submission (K083526); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 119 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 30, 2025Circuit Failure; Circuit Failure

  A TRILOGY 100 VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THERE WAS NO SERIOUS HARM OR INJURY REPORTED. THERE WAS NO ALLEGATION AGAINST THE DEVICE. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, UNUSUAL OPERATION WAS OBSERVED. THE DEVICE'S SYSTEM AND CPU BOARD ASSEMBLY NEEDS TO BE REPLACED TO ADDRESS THE ISSUES. NO ADDITIONAL REPAIRS WERE PERFORMED. IT WAS NOTED THAT THE DEVICE WAS NOT NEEDED FOR INVENTORY AND THE UNIT WAS SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22113939 ↗
• MalfunctionMay 6, 2025Mechanical Problem; Mechanical Problem

  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 VENTILATOR INOPERATIVE ERROR CODE RELATED TO A MOTOR FAILURE WAS OBSERVED. THERE WAS NO REPORTED PATIENT INVOLVEMENT. THE MANUFACTURER¿S SERVICE TECHNICIAN OBSERVED ERR_DSP_MOTOR_FAILURE IN THE DEVICE'S EVENT LOG. THE TECHNICIAN RECOMMENDED REPLACING THE DEVICE'S SYSTEM BOARD AND CPU BOARD ASSEMBLY TO ADDRESS THE ISSUE. NO REPAIR WAS PERFORMED. THE DEVICE IS NOT NEEDED FOR INVENTORY AND WAS SCRAPPED. NO FURTHER INVESTIGATION IS WARRANTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21968847 ↗
• MalfunctionMay 6, 2025Improper Flow or Infusion; Improper Flow or Infusion

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR WAS NOT BLOWING ENOUGH. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE, THE DEVICE'S UNUSUAL OPERATION WAS OBSERVED. THE DEVICES SYSTEM AND CPU BOARD ASSEMBLY NEEDS REPLACED TO ADDRESS THE ISSUE. NO REPAIR PERFORMED DUE TO THE DEVICE NOT NEEDED FOR INVENTORY. THE UNIT WILL BE SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21968289 ↗
• DeathApr 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION THAT A TRILOGY 100 DEVICE IS RETURNING BECAUSE THE PATIENT HAS PASSED AWAY. THERE WAS NO ALLEGATION THAT THE DEVICE CONTRIBUTED TO THE DEATH. LIMITED INFORMATION WAS PROVIDED BY THE CUSTOMER. HOWEVER, THE CUSTOMER DID INDICATE THAT THE PATIENT EXPIRED DUE TO A NON-SPECIFIC NATURAL DISEASE PROGRESSION. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE DEVICE POWERED ON AS IT SHOULD. NO ADDITIONAL REPAIRS WERE PERFORMED. IT WAS NOTED THAT THE DEVICE WAS NOT NEEDED FOR INVENTORY AND THE UNIT WILL BE SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21936152 ↗
• MalfunctionFeb 25, 2025Failure to Charge; Battery Problem; Failure to Charge; Battery Problem

  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 AND PERMANENT FAILURE OF THE DEVICE'S INTERNAL BATTERY. NO REPAIRS PERFORMED. THE UNIT WILL BE SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21459368 ↗
• MalfunctionFeb 25, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  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 "VENTILATOR INOPERATIVE" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. NO REPAIRS PERFORMED. THE UNIT WILL BE SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21457482 ↗
• MalfunctionOct 23, 2024Battery Problem; Battery Problem

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER BECAUSE, DUE TO AN ALLEGATION OF INTERNAL BATTERY ERROR CODES, IT DID NOT MEET THE ACCEPTANCE CRITERIA OF THE EVALUATION PROCESS. THE COMPLAINT WAS CONFIRMED DURING THE DEVICE'S EVALUATION AT THE MANUFACTURER'S SERVICE CENTER. THE INTERNAL BATTERY NEEDED TO BE REPLACED. THE DEVICE WAS SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20517597 ↗
• MalfunctionOct 22, 2024Battery Problem; Battery Problem

  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 INTERNAL BATTERY SHOULD BE REPLACED TO ADDRESS THE ISSUE. NO REPAIR WAS PERFORMED AS THE DEVICE IS TO BE SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20507926 ↗
• InjuryAug 9, 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 MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A VENTILATOR'S SOUND ABATEMENT FOAM. THE REPORTER ALLEGED OF HAVING ASTHMA (NEW OR WORSENING) FROM A TRILOGY 100 DEVICE. MEDICAL INTERVENTION WAS NOT SPECIFIED. NO ADDITIONAL INFORMATION CAN BE REQUESTED AT THIS TIME. THE MANUFACTURER WAS MADE AWARE OF THIS COMPLAINT THROUGH A REPRESENTATIVE OF THE CUSTOMER. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: Asthma

  MAUDE report 19951602 ↗
• MalfunctionDec 11, 2023Failure to Power Up; Failure to Power Up

  DURING THE EVALUATION OF THE TRILOGY100 AT THE MANUFACTURER'S SERVICE CENTER, IT WAS CONFIRMED THAT THE DEVICE DID NOT MEET CRITERIA OF EVALUATION PROCESS FOR INITIAL POWER UP FAILURE. THE DEVICE WAS SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18300296 ↗
• MalfunctionDec 7, 2023Battery Problem; Battery Problem

  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. AT THIS TIME THE EVALUATION AND REPAIR HAVE NOT BEEN COMPLETED. A SUPPLEMENTAL REPORT WILL BE SENT WHEN IT HAS BEEN COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18285026 ↗
• MalfunctionAug 4, 2022Failure to Recalibrate; 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, THE DEVICE FAILED STEPS DURING TESTING. THE DEVICE'S ACTIVE EXHALATION CONTROL MODULE AND SENSOR BOARD WERE REPLACED TO ADDRESS THE ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15164154 ↗
• MalfunctionJun 7, 2022Low Readings; Low Readings

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR WAS DELIVERING LOW AIRFLOW. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE HAS NOT YET BEEN EVALUATED BY 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 14622606 ↗
• MalfunctionApr 13, 2022Degraded; Electrical /Electronic Property Problem; Degraded; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING VISUALIZATION OF PARTICLES IN THE AIR PATH. 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 14102834 ↗
• MalfunctionApr 13, 2022Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING VISUALIZATION OF PARTICLES IN THE AIR PATH. 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 14102719 ↗
• MalfunctionApr 8, 2022Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING VISUALIZATION OF PARTICLES IN THE AIR PATH. 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 14052084 ↗
• MalfunctionMar 17, 2022Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING VISUALIZATION OF PARTICLES IN THE AIR PATH. THERE WAS NO REPORT OF SERIOUS 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 13793283 ↗
• MalfunctionMar 17, 2022Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING VISUALIZATION OF PARTICLES IN THE AIR PATH. THERE WAS NO REPORT OF SERIOUS 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 13793273 ↗
• MalfunctionMar 1, 2022Degraded; Degraded

  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 BLOWER BELLOWS, INLET FOAM, FLOW SENSOR ASSEMBLY AND INLET AIR PATH ASSEMBLY WERE REPLACED DUE TO DIRT AND DUST CONTAMINATION. 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 13638883 ↗
• MalfunctionJan 20, 2022Circuit 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 POWER MANAGEMENT BOARD NEEDS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13308846 ↗
• MalfunctionOct 8, 2021Mechanical Problem; Mechanical Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR WAS ALARMING FOR A LOW INSPIRATORY PRESSURE ALARM 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 ACTIVE EXHALATION CONTROL MODULE WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12597087 ↗
• MalfunctionMay 26, 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 SYSTEM BOARD NEEDS TO BE REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11886908 ↗
• MalfunctionApr 27, 2021Failure to Charge; Failure to Charge

  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 FAILURE OF THE DEVICE TO CHARGE IT'S INTERNAL BATTERY WAS OBSERVED. THE DEVICE'S INTERNAL BATTERY WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11731952 ↗
• MalfunctionNov 19, 2020Circuit Failure; Battery Problem; Circuit Failure; Battery Problem

  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, ERROR CODES RELATED TO THE CHARGING OF THE INTERNAL BATTERY WERE OBSERVED. THE DEVICE'S INTERNAL BATTERY AND POWER MANAGEMENT BOARD WERE REPLACED TO ADDRESS THE ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10869166 ↗
• MalfunctionNov 12, 2020Mechanical 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 ACTIVE EXHALATION CONTROL MODULE WAS OBSERVED. THE DEVICE'S ACTIVE EXHALATION CONTROL MODULE WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10829543 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K083526. One submission often covers many models, so check the product and lot details in each record.

• Z-0882-2023 · Dec 7, 2022 · Open, Classified
  Philips Trilogy 100 Ventilator, Model Numbers 1054260, 1054096, U1054260, U1054260B, 1054260B, CA1054096B, BT1054260, 1054096B, R1054260, RSL1054260, CA1054096, R1054260B, R1054655
• Z-0884-2023 · Dec 7, 2022 · Open, Classified
  Philips Garbin Ventilator, Model Number 1058180B
• 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
• Z-0296-2012 · Oct 11, 2011 · Terminated
  Trilogy 100, 200 and 202 Ventilators The device is intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used fo
• Z-1896-2010 · Jun 10, 2010 · Terminated
  Trilogy 100 Ventilator, Model/Catalog Number 1054260, U1054260 (Domestic). Philips Respironics, Monroeville, PA 15146. Provides continuous or intermittent ventilatory support for