Trilogy Trilogy100 Ventilator, GermanyRecalls & reported problems

Summary

The FDA's MAUDE database contains 696 adverse event reports that list this exact device (DI 00606959022751), received between Sep 23, 2015 and Sep 30, 2026 — classified as 696 malfunctions.

The most frequently reported specific device problem is “Failure to Recalibrate” (214 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 696 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Electrical /Electronic Property Problem; Battery Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950685 ↗
• MalfunctionSep 30, 2026Electrical /Electronic Property Problem; Battery Problem

  The Trilogy 100 was returned to the third-party service center for evaluation. The device was not reported to be in clinical use, and no medical intervention was specified.During evaluation, the device error log was reviewed, and the following errors were identified:E009 ¿ Ventilator Inoperative / Motor Failure: This error indicates a motor blower failure. The motor blower requires replacement.E364 ¿ Internal Li-Ion Battery Fuse Open: This error indicates that the internal Li-Ion battery fuse is open. The internal battery is the final power source and requires replacement.The device also exceeded 30,000 blower hours and was due for 30,000-hour preventive maintenance. The air path kit was noted to be missing. Based on the evaluation findings, replacement of the motor blower and internal battery would be required to address the identified conditions. No parts were replaced because the device was scrapped at the customer's request.Should further investigation provide new information that impacts the outcome of the investigation or the associated medical device reporting, a supplemental report will be submitted accordingly.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50944416 ↗
• MalfunctionJul 1, 2026Failure to Charge; Battery Problem

  A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THIRD-PARTY SERVICE CENTER, A "SERVICE REQUIRED" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S INTERNAL BATTERY WAS REPLACED, AND THE SOFTWARE WAS UPGRADED TO ADDRESS THE ISSUE. ADDITIONALLY, THE PATIENT¿S COMPLAINT WAS NOT CONFIRMED ALONG WITH CONTAMINATION, AND THE DEVICE WAS CORRECTED. AC POWER CORD RETAINER IS MISSING. RUBBER FEET ARE MISSING. HANDLE IS CRACKED. FRONT LOGO IS DETERIORATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25675651 ↗
• MalfunctionJun 30, 2026Electrical /Electronic Property Problem

  A TRILOGY 100 VENTILATOR DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. DURING THE EVALUATION, THE SERVICE TECHNICIAN OBSERVED CELL UNDERVOLTAGE ERROR CODE E210 (ERR_TDA_CELL_UNDER_VOLTAGE_INT_BATTERY_LOG _ONLY) IN THE ERROR LOG. THIS ERROR IS GENERATED FROM A BATTERY CELL UNDER-VOLTAGE INSIDE THE BATTERY PACK. NO DOCUMENTATION OF A REPLACED COMPONENT TO ADDRESS THE ISSUE. ADDITIONALLY, ONE RUBBER FOOT, THE PASSIVE PORTING BLOCK, AND POWER CORD CLAMP WERE MISSING. THE MAINTENANCE LABEL AND POLLEN AIR FILTER NEED TO BE REPLACED FOR PREVENTIVE MAINTENANCE. NO PARTS WILL BE REPLACED; THE DEVICE WILL BE SCRAPPED AS PER CUSTOMER REQUEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25669953 ↗
• MalfunctionJun 29, 2026Failure to Charge; Battery Problem

  A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THIRD-PARTY SERVICE CENTER, A SERVICE REQUIRED CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG RELATED TO ERR_PERM_FAIL_INT_LI_ION. THE DEVICE'S INTERNAL BATTERY WAS REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, THE DEVICE WAS CORRECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25659482 ↗
• MalfunctionJun 19, 2026Failure to Charge; Battery Problem

  A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THIRD-PARTY SERVICE CENTER, A "SERVICE REQUIRED" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S INTERNAL BATTERY NEED TO BE REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, CONTAMINATION WAS ALSO OBSERVED AND THE DEVICE WAS CORRECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25557883 ↗
• MalfunctionMay 29, 2026Failure to Recalibrate

  A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE FAILED TEST STEPS FOR OXYGEN LOW FLOW AND POSITIVE FLOW VERIFY DURING TESTING. THE FOAM HAD BEEN VERIFIED AND WAS INSTALLED CORRECTLY. ADDITIONALLY, CONTAMINATION WAS ALSO OBSERVED AND THE DEVICE WAS CORRECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25340488 ↗
• MalfunctionMay 29, 2026Failure to Recalibrate

  A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE FAILED TEST STEPS FOR LOW OXYGEN FLOW DURING TESTING. THE FOAM WAS INSTALLED CORRECTLY. ADDITIONALLY, DUST ON BLOWER BOX WAS ALSO OBSERVED AND THE DEVICE WAS CORRECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25337895 ↗
• MalfunctionMay 28, 2026Failure to Recalibrate

  A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE FAILED TEST STEPS FOR OXYGEN LOW FLOW, ACTIVE EXHALATION PURGE VALVE OPEN AND CLOSED, NURSE CALL OFF DURING TESTING. THE FOAM HAD BEEN INSTALLED CORRECTLY. ADDITIONALLY, CONTAMINATION WAS ALSO OBSERVED AND THE DEVICE WAS CORRECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25326033 ↗
• MalfunctionMay 28, 2026Failure to Recalibrate

  A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE FAILED A TEST STEP FOR OXYGEN LOW FLOW DURING TESTING. THE FOAM HAD BEEN INSTALLED CORRECTLY. ADDITIONALLY, THE DEVICE WAS CORRECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25326032 ↗
• MalfunctionMay 28, 2026Failure to Recalibrate

  A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE FAILED TEST STEPS FOR OXYGEN LOW FLOW AND POSITIVE FLOW VERIFY DURING TESTING. THE FOAM HAD BEEN VERIFIED AND WAS INSTALLED CORRECTLY. ADDITIONALLY, CONTAMINATION WAS ALSO OBSERVED AND THE DEVICE WAS CORRECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25326028 ↗
• MalfunctionMay 28, 2026Failure to Recalibrate

  A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, A "SERVICE REQUIRED" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG AND THE DEVICE FAILED TEST STEPS FOR ACTIVE EXHALATION PROPORTIONAL VALVE OPEN AND CLOSED, POSITIVE FLOW VERIFY DURING TESTING. ADDITIONALLY, CONTAMINATION WAS ALSO OBSERVED AND THE DEVICE WAS CORRECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25326026 ↗
• MalfunctionMay 28, 2026Failure to Recalibrate

  A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE FAILED TEST STEPS FOR LCD BRIGHTNESS AND SCREEN TEST, MONITOR PRESS. VER. DURING TESTING. ADDITIONALLY, DUST ON BLOWER BOX WAS ALSO OBSERVED AND THE DEVICE WAS CORRECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25324513 ↗
• MalfunctionMay 28, 2026Failure to Recalibrate

  A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE FAILED TEST STEPS FOR LOW OXYGEN FLOW DURING TESTING. THE FOAM WAS INSTALLED CORRECTLY. ADDITIONALLY, DUST ON BLOWER BOX WAS ALSO OBSERVED AND THE DEVICE WAS CORRECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25324491 ↗
• MalfunctionMay 6, 2026Failure to Recalibrate

  A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE FAILED A TEST STEP FOR LOW OXYGEN FLOW DURING TESTING. THE FOAM HAS BEEN INSTALLED CORRECTLY. ADDITIONALLY, BOTTOM CASE IS CRACKED, HANDLE IS CRACKED, RUBBER FEET ARE MISSING. THE UNIT CAME FOR REMEDIATION ONLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25093342 ↗
• MalfunctionMay 6, 2026Failure to Recalibrate

  A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE FAILED TEST STEPS FOR ACTIVE EXHALATION PROPORTIONAL VALVE OPENED, POSITIVE FLOW VERIFY AND NEGATIVE FLOW VERIFY DURING TESTING. THE FOAM HAS BEEN VERIFIED AND WAS INSTALLED CORRECTLY. ADDITIONALLY, O-RINGS REPLACEMENT REQUIRED. NO PM REQUIRED. RUBBER FEET ARE MISSING. THERE WAS DUST ON BLOWER BOX. THE UNIT CAME FOR REMEDIATION ONLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25093326 ↗
• MalfunctionMay 6, 2026Failure to Calibrate

  A TRILOGY 100 VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR FOAM REMEDIATION ON THE DEVICE. THERE WAS NO HARM OR INJURY REPORTED. THERE WAS NO EVIDENCE THAT THE DEVICE WAS IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE FAILED A LOW O2 FLOW TEST STEP AND A NEGATIVE FLOW VERIFICATION TEST STEP. NO FURTHER TESTING WAS PERFORMED. THE DEVICE WAS VISUALLY INSPECTED AND FOUND NO EVIDENCE OF FOAM DEGRADATION. THE SOUND ABATEMENT FOAM WAS REPLACED PREVENTATIVELY. THE DEVICE WAS RETURNED FOR REMEDIATION ONLY AND WAS RETURNED TO THE CUSTOMER UNREPAIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25091919 ↗
• MalfunctionMay 5, 2026Failure to Recalibrate

  A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE FAILED TEST STEPS FOR OXYGEN LOW FLOW, LCD SCREEN TEST AND POSITIVE FLOW VERIFY DURING TESTING. THE FOAM HAD BEEN VERIFIED AND WAS INSTALLED CORRECTLY. ADDITIONALLY, CONTAMINATION WAS ALSO OBSERVED AND THE DEVICE WAS CORRECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25089352 ↗
• MalfunctionMay 5, 2026Failure to Recalibrate

  A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE FAILED TEST STEPS FOR POSITIVE AND NEGATIVE FLOW VERIFY DURING TESTING. ADDITIONALLY, CONTAMINATION WAS ALSO OBSERVED AND THE DEVICE WAS CORRECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25089351 ↗
• MalfunctionMay 5, 2026Failure to Recalibrate

  A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE FAILED TEST STEPS FOR OXYGEN LOW FLOW, CONTROL PRESSURE VERIFY, MONITOR PRESSURE VERIFY, PROXIMAL PRESSURE VERIFY DURING TESTING. THE FOAM HAD BEEN VERIFIED AND WAS INSTALLED CORRECTLY. ADDITIONALLY, CONTAMINATION WAS ALSO OBSERVED AND THE DEVICE WAS CORRECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25089350 ↗
• MalfunctionMay 5, 2026Failure to Recalibrate

  A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE FAILED A TEST STEP FOR OXYGEN LOW FLOW DURING TESTING. ADDITIONALLY, CONTAMINATION WAS ALSO OBSERVED AND THE DEVICE WAS CORRECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25089349 ↗
• MalfunctionMay 5, 2026Failure to Recalibrate

  A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE FAILED TEST STEPS FOR OXYGEN LOW FLOW AND NEGATIVE FLOW VERIFY DURING TESTING. THE FOAM WAS VERIFIED AND WAS CORRECTLY INSTALLED. ADDITIONALLY, THE DEVICE WAS CORRECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25089348 ↗
• MalfunctionMay 5, 2026Failure to Recalibrate

  A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE FAILED A TEST STEP FOR OXYGEN LOW FLOW DURING TESTING. THE FOAM HAS BEEN INSTALLED CORRECTLY. ADDITIONALLY, THE DEVICE WAS CORRECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25089347 ↗
• MalfunctionMay 5, 2026Failure to Recalibrate

  A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE FAILED A TEST STEP FOR LOW OXYGEN FLOW DURING TESTING. THE FOAM HAS BEEN VERIFIED AND WAS INSTALLED CORRECTLY. ADDITIONALLY, NO ERRORS OCCURRED. LCD GLASS IS CRACKED, FRONT CASE IS DAMAGED, REAR CASE IS DAMAGED, HANDLE IS DAMAGED, BOTTOM CASE IS DAMAGED. NO PM REQUESTED. THERE WAS DUST ON BLOWER BOX. THE UNIT CAME FOR REMEDIATION ONLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25086276 ↗
• MalfunctionMay 5, 2026Failure to Recalibrate

  A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE FAILED A TEST STEP FOR LOW OXYGEN FLOW DURING TESTING. THE FOAM HAS BEEN INSTALLED CORRECTLY. ADDITIONALLY, THERE WAS DUST ON BLOWER BOX. THE UNIT CAME FOR REMEDIATION ONLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25086268 ↗

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-0884-2023 · Dec 7, 2022 · Open, Classified
  Philips Garbin Ventilator, Model Number 1058180B
• 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-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