Trilogy 200 LifeVent200 Ventilator, Sapio, BluetoothRecalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00606959050099), received between Jan 28, 2019 and May 6, 2026 — classified as 1 death, 31 malfunctions.

The most frequently reported specific device problem is “Computer Software Problem” (17 reports).

5 other recalls cover devices cleared under the same FDA submission (K093416); 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 32 reports, in the reporter's own words as published by the FDA.

• 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 25096308 ↗
• 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 LIFE VENT 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 AND THE RUN-IN TESTING WAS REDONE TO ADDRESS THE ISSUE. THE DEVICE PASSED FINAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25068781 ↗
• 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. 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 25068165 ↗
• MalfunctionMay 1, 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 25054259 ↗
• MalfunctionMay 1, 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 25054216 ↗
• MalfunctionMay 1, 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 25054212 ↗
• 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 HW POWER FAIL 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 25049564 ↗
• 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 25049490 ↗
• 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 25047204 ↗
• 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 25046424 ↗
• 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 25038522 ↗
• 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 25038483 ↗
• 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 25038469 ↗
• 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 25038438 ↗
• MalfunctionApr 29, 2026Device Sensing 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 FAILED A TEST STEP RELATED TO THE LCD SCREEN. THE DEVICE WAS REQUESTED TO RETURN UNREPAIRED TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25032728 ↗
• 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 25028913 ↗
• MalfunctionApr 28, 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 25021855 ↗
• MalfunctionApr 28, 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 25021751 ↗
• MalfunctionApr 13, 2026Electrical /Electronic Property 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 NURSE CALL FAILURE WAS IDENTIFIED. THE DEVICE ONLY CAME IN FOR REMEDIATION, THEREFORE NO REPAIR WAS PERFORMED. THE DEVICE WAS TESTED AGAIN AND FAILED 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 24865031 ↗
• MalfunctionApr 10, 2026Calibration 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 24844708 ↗
• MalfunctionApr 10, 2026Calibration 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. ADDITIONAL FINDINGS NOT RELATED TO THE MALFUNCTION/ISSUE: THE DEVICE FAILED PRESSURE SENSOR TEST. THE FOAM HAS BEEN INSTALLED CORRECTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24844332 ↗
• MalfunctionApr 10, 2026Calibration 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 24839130 ↗
• MalfunctionMar 5, 2026Degraded; Failure to Recalibrate

  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. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR EVALUATION. DURING THE EVALUATION OF THE DEVICE, FOAM PARTICLES WERE OBSERVED. HOWEVER, THE DEVICE FAILED THE POSITIVE FLOW VERIFICATION TEST DURING FINAL TESTING. ADDITIONALLY, THERE IS DUST ON THE BLOWER BOX, THE PATIENT¿S COMPLAINT WAS CONFIRMED, AND THE DEVICE WAS CORRECTED. THE DEVICE HANDLE O-RINGS ARE DAMAGED. NO PM REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24523776 ↗
• MalfunctionMar 5, 2026Degraded; Failure to Recalibrate

  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. THERE WAS NO HARM OR INJURY REPORTED. THE LIFEVENT200 VENTILATOR WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR EVALUATION. DURING THE EVALUATION OF THE DEVICE, FOAM PARTICLES WERE OBSERVED. ALSO, THE DEVICE FAILED THE POSITIVE FLOW VERIFICATION TEST DURING FINAL TESTING. ADDITIONALLY, NOT RELATED TO THE ISSUE, THERE IS DUST ON THE BLOWER BOX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24518986 ↗
• MalfunctionMar 2, 2026Degraded

  A LIFEVENT200 VENTILATOR DEVICE WAS RETURNED TO A THIRD-PARTY 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. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND VISIBLE FOAM PARTICLES WERE OBSERVED. ADDITIONALLY, THE PATIENT¿S COMPLAINT WAS CONFIRMED ALONG WITH CONTAMINATION, AND THE DEVICE WAS CORRECTED. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24484071 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K093416. One submission often covers many models, so check the product and lot details in each record.

• Z-0883-2023 · Dec 7, 2022 · Open, Classified
  Philips Trilogy 200 Ventilator, Model Numbers 1040005, U1040005, 1040005B, U1040005B, CA1032800B, CA1032800, KO1032800, 1032800, R1032804TP, R1032804B, R1032804TPV, 1032804B
• 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