Trilogy 100 Trilogy100 Ventilator, Bluetooth, ItalyRecalls & reported problems

Summary

The FDA's MAUDE database contains 146 adverse event reports that list this exact device (DI 00606959042933), received between Mar 20, 2019 and Jun 30, 2026 — classified as 1 injury, 145 malfunctions.

The most frequently reported specific device problem is “Calibration Problem” (43 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. 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 146 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 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, NEG FLOW VERIFY: DP2, MONITOR PRESSURE VERIFICATION 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 25670329 ↗
• MalfunctionJun 19, 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. 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 25557875 ↗
• MalfunctionMay 6, 2026Electrical /Electronic Property Problem; Battery Problem

  THE TRILOGY 100 VENTILATOR WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR REMEDIATION. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. DURING THE EVALUATION OF THE DEVICE ERROR CODES IN RELATION TO CELL UNDERVOLTAGE WAS OBSERVED IN THE DEVICE EVENT LOG. THE TECHNICIAN CONFIRMED THAT THERE WERE NO FUNCTIONAL ISSUES DETECTED AND NO PARTS WERE REPLACED IN REGARD TO THE ERROR CODES OBSERVED. THE DEVICE WAS SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25100682 ↗
• 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 25094794 ↗
• 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 TRILOGY 100 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, THE DEVICE WAS VISUALLY INSPECTED AND FOUND NO EVIDENCE OF FOAM DEGRADATION. THE DEVICE FAILED FUNCTIONAL TESTING RELATING TO THE POSITIVE FLOW VERIFICAITON TEST STEP. THE SOFTWARE WAS UPGRADED TO ADDRESS THE ISSUE. RUN-IN TESTING WAS PERFORMED AGAIN AND THE DEVICE PASSED. ADDITIONALLY, A NOT-REPORTABLE INTERNAL BATTERY DEPLETED ERROR CODE WAS FOUND IN THE DEVICE'S ERROR LOG. THE SERVICE TECHNICIAN STATES THAT THE INTERNAL BATTERY WAS CHARGED TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25068394 ↗
• MalfunctionApr 30, 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 25048809 ↗
• MalfunctionApr 30, 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 TRILOGY 100 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, THE DEVICE WAS VISUALLY INSPECTED AND FOUND NO EVIDENCE OF FOAM DEGRADATION. THE DEVICE FAILED FUNCTIONAL TESTING RELATING TO THE POSITIVE FLOW VERIFICAITON TEST STEP. THE SOFTWARE WAS UPGRADED TO ADDRESS THE ISSUE. RUN-IN TESTING WAS PERFORMED AGAIN AND THE DEVICE PASSED. ADDITIONALLY, A NOT-REPORTABLE LOW INTERNAL BATTERY ERROR CODE WAS FOUND IN THE DEVICE'S ERROR LOG. THE SERVICE TECHNICIAN STATES THAT THE INTERNAL BATTERY WAS CHARGED TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25046893 ↗
• MalfunctionApr 30, 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 TRILOGY 100 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, THE DEVICE WAS VISUALLY INSPECTED AND FOUND NO EVIDENCE OF FOAM DEGRADATION. THE FOAM WAS REPLACED PREVENTATIVELY. THE DEVICE FAILED FUNCTIONAL TESTING RELATING TO THE POSITIVE FLOW VERIFICAITON TEST STEP. THE SOFTWARE WAS UPGRADED TO ADDRESS THE ISSUE. RUN-IN TESTING WAS PERFORMED AGAIN AND THE DEVICE PASSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25046650 ↗
• MalfunctionApr 30, 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 TRILOGY 100 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 POSITIVE FLOW VERIFICATION. THE SOFTWARE WAS UPGRADED TO ADDRESS THE ISSUE. THE SERVICE TECHNICIAN STATES THAT THE DEVICE ALSO FAILED THE FOLLOWING NOT-REPORTABLE REPAIR TEST STEPS: NEW PORTING BLOCK, SD CARD TO SHIP, TIME OUT EVENT LOG ERROR, DEBUG LOG, AND RESET OPERATIONAL HOURS. THE DEVICE PASSED FINAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25045580 ↗
• MalfunctionApr 30, 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 TRILOGY 100 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, THE DEVICE WAS VISUALLY INSPECTED AND FOUND NO EVIDENCE OF FOAM DEGRADATION. THE DEVICE FAILED FUNCTIONAL TESTING RELATING TO THE POSITIVE FLOW VERIFICATION TEST STEP. THE SOFTWARE WAS UPGRADED TO ADDRESS THE ISSUE. RUN-IN TESTING WAS PERFORMED AGAIN AND THE DEVICE PASSED. ADDITIONALLY, A NOT-REPORTABLE INTERNAL BATTERY DEPLETED AND CHECK CIRCUIT ERROR CODE WERE FOUND IN THE DEVICE'S ERROR LOG. THE SERVICE TECHNICIAN STATES THAT THE INTERNAL BATTERY WAS CHARGED AND THE TUBING WAS RECONNECTED TO RESOLVE THE ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25044938 ↗
• MalfunctionApr 30, 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 TRILOGY 100 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, THE DEVICE WAS VISUALLY INSPECTED AND FOUND NO EVIDENCE OF FOAM DEGRADATION. THE DEVICE FAILED FUNCTIONAL TESTING RELATING TO THE POSITIVE FLOW VERIFICATION TEST STEP. THE SOFTWARE WAS UPGRADED TO ADDRESS THE ISSUE. ADDITIONALLY, THE DEVICE FAILED A NOT-REPORTABLE TEST STEP RELATING TO A DAMAGED LCD DISPLAY. THERE IS NO DOCUMENTATION STATED ON A ROOT CAUSE OR A COMPONENT REPLACEMENT. ADDITIONALLY, A NOT-REPORTABLE INTERNAL BATTERY DEPLETED, AND CHECK CIRCUIT ERROR CODE WERE FOUND IN THE DEVICE'S ERROR LOG. THE SERVICE TECHNICIAN STATES THAT THE INTERNAL BATTERY WAS CHARGED AND THE TUBING WAS RECONNECTED TO RESOLVE THE ISSUES. RUN-IN TESTING WAS PERFORMED AGAIN AND THE DEVICE PASSED. THE CUSTOMER REQUESTED THE RETURN OF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25044524 ↗
• MalfunctionApr 30, 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 TRILOGY 100 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, THE DEVICE WAS VISUALLY INSPECTED AND FOUND NO EVIDENCE OF FOAM DEGRADATION. THE DEVICE FAILED FUNCTIONAL TESTING RELATING TO THE POSITIVE FLOW VERIFICATION TEST STEP. THE SOFTWARE WAS UPGRADED TO ADDRESS THE ISSUE. ADDITIONALLY, THE DEVICE FAILED A NOT-REPORTABLE TEST STEP RELATING TO THE NURSE CALL. THE DEVICE WAS CHECKED AGAIN, AND THE NURSE CALL WAS FUNCTIONAL. ALSO, A NOT-REPORTABLE INTERNAL BATTERY DEPLETED, AND LOW EXPIRATORY PRESSURE ERROR CODE WERE FOUND IN THE DEVICE'S ERROR LOG. THE SERVICE TECHNICIAN STATES THAT THE INTERNAL BATTERY WAS CHARGED TO RESOLVE THE ISSUE. RUN-IN TESTING WAS PERFORMED AGAIN AND THE DEVICE PASSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25043651 ↗
• MalfunctionApr 29, 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 25037701 ↗
• MalfunctionApr 29, 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 ONLY CAME IN FOR REMEDIATION, THEREFORE NO REPAIR WAS PERFORMED. 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 25037606 ↗
• MalfunctionApr 29, 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 ONLY CAME IN FOR REMEDIATION, THEREFORE NO REPAIR WAS PERFORMED. IN ADDITION, THE DEVICE WAS VISUALLY INSPECTED AND FOUND NO EVIDENCE OF FOAM DEGRADATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25037357 ↗
• MalfunctionApr 29, 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 TRILOGY 100 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 NEGATIVE FLOW TEST STEP. THE SOFTWARE WAS UPGRADED TO ADDRESS THE ISSUE. ADDITIONALLY, A NOT-REPORTABLE CHECK CIRCUIT ERROR CODE WAS FOUND IN THE DEVICE'S ERROR LOG. THE SERVICE TECHNICIAN STATES THAT THE CIRCUIT/TUBING WAS CHECKED TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25036866 ↗
• MalfunctionApr 29, 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 TRILOGY 100 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 POSITICE FLOW TEST STEP. THE SOFTWARE WAS UPGRADED TO ADDRESS THE ISSUE. RUN-IN TESTING WAS PERFORMED AGAIN AND THE DEVICE PASSED. ADDITIONALLY, A NOT-REPORTABLE INTERNAL BATTERY DEPLETED ERROR CODE WAS FOUND IN THE DEVICE'S ERROR LOG. THE SERVICE TECHNICIAN STATES THAT THE INTERNAL BATTERY WAS CHARGED RESOLVE THE ISSUE. THE DEVICE PASSED ALL FINAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25036855 ↗
• MalfunctionApr 29, 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 TRILOGY 100 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 AND NEGATIVE FLOW TEST STEPS. THE SOFTWARE WAS UPGRADED TO ADDRESS THE ISSUES. RUN-IN TESTING WAS PERFORMED AGAIN AND THE DEVICE PASSED. ADDITIONALLY, A NOT-REPORTABLE INTERNAL BATTERY DEPLETED AND CHECK CIRCUIT ERROR CODE WERE FOUND IN THE DEVICE'S ERROR LOG. THE SERVICE TECHNICIAN STATES THAT THE INTERNAL BATTERY WAS RECHARGED AND THE CIRCUIT/TUBING WAS CHECKED TO RESOLVE THE ERRORS. THE DEVICE PASSED ALL FINAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25036363 ↗
• MalfunctionApr 29, 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 TRILOGY 100 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 AND NEGATIVE FLOW TEST STEPS. THE SOFTWARE WAS UPGRADED TO ADDRESS THE ISSUES. ADDITIONALLY, A NOT-REPORTABLE INTERNAL BATTERY DEPLETED ERROR CODE WAS FOUND IN THE DEVICE'S ERROR LOG. THE SERVICE TECHNICIAN STATES THAT THE INTERNAL BATTERY WAS RECHARGED TO RESOLVE THE ERROR. THE DEVICE PASSED ALL FINAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25036362 ↗
• MalfunctionApr 29, 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 25036349 ↗
• MalfunctionApr 29, 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 25036023 ↗
• MalfunctionApr 29, 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 TRILOGY 100 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 TO ADDRESS THE ISSUE. RUN-IN TESTING WAS PERFORMED AGAIN AND THE DEVICE PASSED. ADDITIONALLY, A NOT-REPORTABLE INTERNAL BATTERY DEPLETED ERROR CODE WAS FOUND IN THE DEVICE'S ERROR LOG. THE SERVICE TECHNICIAN STATES THAT THE INTERNAL BATTERY WAS RECHARGED TO RESOLVE THE ERROR. THE DEVICE PASSED ALL FINAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25036022 ↗
• MalfunctionApr 29, 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 ONLY CAME IN FOR REMEDIATION, THEREFORE NO REPAIR WAS PERFORMED. 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 25035835 ↗
• MalfunctionApr 29, 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 ONLY CAME IN FOR REMEDIATION, THEREFORE NO REPAIR WAS PERFORMED. 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 25034902 ↗
• MalfunctionApr 29, 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 ONLY CAME IN FOR REMEDIATION, THEREFORE NO REPAIR WAS PERFORMED. THE DEVICE WAS RUN IN AND 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 25034693 ↗

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