Trilogy 100 Trilogy100 Ventilator, Bluetooth, InternationalRecalls & reported problems

Summary

The FDA's MAUDE database contains 186 adverse event reports that list this exact device (DI 00606959026469), received between Aug 15, 2016 and Jul 1, 2026 — classified as 1 death, 185 malfunctions.

The most frequently reported specific device problem is “Failure to Calibrate” (28 reports).

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 186 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 1, 2026Battery 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 NEEDS TO BE REPLACED TO ADDRESS THE ISSUE. THE UNIT IS TO BE SCRAPPED AT THE REQUEST OF THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25675652 ↗
• MalfunctionMay 6, 2026Device Alarm System; Circuit Failure

  A TRILOGY 100 WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR REMEDIATION. THERE WAS NO HARM OR INJURY REPORTED. THERE WAS NO EVIDENCE THE DEVICE WAS IN PATIENT USE. DURING THE EVALUATION THE DEVICE'S NURSE CALL CONNECTOR WAS MISSING. THE DEVICE'S INTERFACE BOARD WAS REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, NOT RELATED TO THE REPORTABLE EVENT THE DEVICE WAS ALARMING FOR A CIRCUIT DISCONNECT ALARM CONDITION AND AN INTERNAL BATTERY DEPLETED ALARM CONDITION. THE TUBING WAS CHECKED AND THE INTERNAL BATTERY RECHARGED TO ADDRESS THE ISSUES. THIS WOULD NOT AFFECT THE DEVICE'S ABILITY TO DELIVER THERAPY AS DESIGNED. THE DEVICE WAS TESTED AND PASSED ALL FINAL TESTING. IN ADDITION, THE DEVICE WAS VISUALLY INSPECTED AND FOUND NO EVIDENCE OF FOAM DEGRADATION. THE SOUND ABATEMENT FOAM WAS REPLACED PREVENTATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25096100 ↗
• MalfunctionMay 6, 2026Device Alarm System; Circuit Failure

  A TRILOGY 100 WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR REMEDIATION. THERE WAS NO HARM OR INJURY REPORTED. THERE WAS NO EVIDENCE THE DEVICE WAS IN PATIENT USE. DURING THE EVALUATION THE DEVICE FAILED THE NURSE CALL ON/OFF TEST STEP DURING TESTING. THE DEVICE'S INTERFACE BOARD WAS REPLACED TO ADDRESS THE ISSUE. THE DEVICE WAS TESTED AND PASSED ALL FINAL TESTING. IN ADDITION, THE DEVICE WAS VISUALLY INSPECTED AND FOUND NO EVIDENCE OF FOAM DEGRADATION. THE SOUND ABATEMENT FOAM WAS REPLACED PREVENTATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25095448 ↗
• 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 POSITIVE AND NEGATIVE FLOW VERIFICATION TEST STEP. NO FURTHER TESTING WAS PERFORMED. THE DEVICE WAS VISUALLY INSPECTED AND FOUND NO EVIDENCE OF FOAM DEGRADATION. ADDITIONALLY, NOT RELATED TO THE REPORTABLE EVENT THE DEVICE WAS ALARMING FOR AN INTERNAL BATTERY DEPLETED ALARM CONDITION. THE INTERNAL BATTERY RECHARGED TO ADDRESS THE ISSUE. THE DEVICE FAILED A TEST STEP FOR A SIGNIFICANT EVENT LOG ISSUE INDICATING A LOW EXHALED TIDAL VOLUME ALARM CONDITION. THIS IS A USER SETTABLE ALARM CONDITION. THESE ISSUES WOULD NOT AFFECT THE DEVICE'S ABILITY TO DELIVER THERAPY AS DESIGNED. 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 25094452 ↗
• MalfunctionMay 6, 2026Failure to Calibrate; Battery Problem

  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 SIGNIFICANT EVENT LOG TEST STEP FOR A SERVICE REQUIRED ALARM CONDITION INDICATING AN INTERNAL BATTERY LOW STATE OF HEALTH. NO FURTHER TESTING WAS PERFORMED. THE DEVICE WAS VISUALLY INSPECTED AND FOUND NO EVIDENCE OF FOAM DEGRADATION. ADDITIONALLY, NOT RELATED TO THE REPORTABLE EVENT THE DEVICE WAS ALARMING FOR A CIRCUIT DISCONNECT ALARM CONDITION. THE TUBING WAS RECONNECTED TO ADDRESS THE ISSUE. THIS WOULD NOT AFFECT THE DEVICE'S ABILITY TO DELIVER THERAPY AS DESIGNED. 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 25093680 ↗
• 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. NO FURTHER TESTING WAS PERFORMED. THE DEVICE WAS VISUALLY INSPECTED AND FOUND NO EVIDENCE OF FOAM DEGRADATION. ADDITIONALLY, NOT RELATED TO THE REPORTABLE EVENT THE DEVICE WAS ALARMING FOR AN INTERNAL BATTERY DEPLETED ALARM CONDITION. THE INTERNAL BATTERY RECHARGED TO ADDRESS THE ISSUE. THIS WOULD NOT AFFECT THE DEVICE'S ABILITY TO DELIVER THERAPY AS DESIGNED. 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 25092297 ↗
• MalfunctionMay 6, 2026Mechanical Problem; Failure to Calibrate

  A TRILOGY 100 WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR REMEDIATION. THERE WAS NO HARM OR INJURY REPORTED. THERE WAS NO EVIDENCE THE DEVICE WAS IN PATIENT USE. DURING THE EVALUATION THE DEVICE FAILED AN ACTIVE EXHALATION PROPORTIONAL VALVE OPENED TEST STEP DURING TESTING. THE DEVICE'S ACTIVE EXHALATION CONTROL MODULE WAS REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, NOT RELATED TO THE REPORTABLE EVENT THE DEVICE WAS ALARMING FOR A CIRCUIT DISCONNECT ALARM CONDITION AND AN INTERNAL BATTERY DEPLETED ALARM CONDITION. THE TUBING WAS CHECKED AND THE INTERNAL BATTERY RECHARGED TO ADDRESS THE ISSUES. THE DEVICE'S MOTOR BLOWER ASSEMBLY, FLOW SENSOR ASSEMBLY AND TUBING WERE REPLACED DUE TO TOBACCO CONTAMINATION. THESE ISSUES WOULD NOT AFFECT THE DEVICE'S ABILITY TO DELIVER THERAPY AS DESIGNED. THE DEVICE WAS TESTED AND PASSED ALL FINAL TESTING. IN ADDITION, THE DEVICE WAS VISUALLY INSPECTED AND FOUND NO EVIDENCE OF FOAM DEGRADATION. THE SOUND ABATEMENT FOAM WAS REPLACED PREVENTATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25092295 ↗
• 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 AN ACTIVE EXHALATION PURGE VALVE CLOSED TEST STEP. NO FURTHER TESTING WAS PERFORMED. THE DEVICE WAS VISUALLY INSPECTED AND FOUND NO EVIDENCE OF FOAM DEGRADATION. ADDITIONALLY, NOT RELATED TO THE REPORTABLE EVENT THE DEVICE WAS ALARMING FOR A CIRCUIT DISCONNECT ALARM CONDITION, AN INTERNAL BATTERY DEPLETED ALARM CONDITION AND A DETACHABLE BATTERY FAILURE ALARM CONDITION. THE TUBING WAS CHECKED, THE INTERNAL BATTERY RECHARGED AND THE DETACHABLE BATTERY NEEDS TO BE REPLACED TO ADDRESS THE ISSUES. THESE ISSUES WOULD NOT AFFECT THE DEVICE'S ABILITY TO DELIVER THERAPY AS DESIGNED. 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 25092208 ↗
• 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 AN ACTIVE EXHALATION PURGE VALVE CLOSED TEST STEP. NO FURTHER TESTING WAS PERFORMED. THE DEVICE WAS VISUALLY INSPECTED AND FOUND NO EVIDENCE OF FOAM DEGRADATION. ADDITIONALLY, NOT RELATED TO THE REPORTABLE EVENT THE DEVICE WAS ALARMING FOR A CIRCUIT DISCONNECT ALARM CONDITION. THE TUBING WAS CHECKED TO ADDRESS THE ISSUE. THIS WOULD NOT AFFECT THE DEVICE'S ABILITY TO DELIVER THERAPY AS DESIGNED. 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 25092207 ↗
• 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 'MONIT PRESS VER' TEST STEP. THE SOFTWARE WAS UPGRADED TO ADDRESS THE ISSUE. RUN-IN TESTING WAS PERFORMED AGAIN AND PASSED. 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. THE DEVICE PASSED ALL FINAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25036367 ↗
• 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. DURING THE EVALUATION AND FUNCTIONAL TESTING OF THE DEVICE AN ERROR CODE RELATED TO O2 FLOW AND FLOW VERIFICATION 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 25032768 ↗
• 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 A THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND NO EVIDENCE OF FOAM DEGRADATION . HOWEVER, THE DEVICE FAILED A TEST STEP RELATED TO (O2 LOW FLOW AND NEG FLOW VERIFY). THE DEVICE CAME ONLY FOR REMEDIATION AND WILL BE RETURNED TO THE CUSTOMER UNREPAIRED. THE SOUND ABATEMENT FOAM WAS REPLACED PREVENTATIVELY. ADDITIONALLY, DURING THE EVALUATION ERROR CODE IN RELATION TO ( CHECK CIRCUIT) WAS RECORDED IN THE DEVICE EVENT LOG UNRELATED TO THE REPORTED MALFUNCTION. THE TECHNICIAN RECOMMENDED CHECKING THE TUBING TO ADDRESS THE ISSUES. DUST WAS CONFIRMED ON THE BLOWER BOX. THE RUBBER FEET WAS MISSING, AND HANDLE O RINGS WERE DAMAGED. THE SOFTWARE WAS UPGRADED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25032173 ↗
• 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. DURING THE EVALUATION AND FUNCTIONAL TESTING OF THE DEVICE AN ERROR CODE RELATED TO O2 FLOW AND FLOW VERIFICATION 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 25031995 ↗
• 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 A THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND NO EVIDENCE OF FOAM DEGRADATION . HOWEVER, THE DEVICE FAILED A TEST STEP RELATED TO (O2 LOW FLOW, LCD BRIGHTNESS, AND LCD SCREEN TEST. THE LCD SCREEN WAS CONFIRMED TO BE DAMAGED. THE DEVICE CAME ONLY FOR REMEDIATION AND WILL BE RETURNED TO THE CUSTOMER UNREPAIRED. THE SOUND ABATEMENT FOAM WAS REPLACED PREVENTATIVELY. ADDITIONALLY, DURING THE EVALUATION ERROR CODE IN RELATION TO ( CHECK CIRCUIT) WAS RECORDED IN THE DEVICE EVENT LOG UNRELATED TO THE REPORTED MALFUNCTION. THE TECHNICIAN RECOMMENDED CHECKING THE TUBING TO ADDRESS THE ISSUES. DUST WAS CONFIRMED ON THE BLOWER BOX. THE RUBBER FEET WAS MISSING, AND HANDLE O RINGS WERE DAMAGED. THE SOFTWARE WAS UPGRADED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25031611 ↗
• 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. DURING THE EVALUATION AND FUNCTIONAL TESTING OF THE DEVICE AN ERROR CODE RELATED TO PRESSURE AND FLOW VERIFICATION 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 25031371 ↗
• 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. DURING THE EVALUATION AND FUNCTIONAL TESTING OF THE DEVICE AN ERROR CODE RELATED TO THE ACTIVE EXHALATION VALVE AND 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 25031162 ↗
• 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. DURING THE EVALUATION AND FUNCTIONAL TESTING OF THE DEVICE AN ERROR CODE RELATED TO PRESSURE VERIFICATION 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 25028456 ↗
• 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. 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. 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 25028453 ↗
• 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. DURING THE EVALUATION AND FUNCTIONAL TESTING OF THE DEVICE AN ERROR CODE RELATED TO FLOW VERIFICATION 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 25028295 ↗
• 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. DURING THE EVALUATION AND FUNCTIONAL TESTING OF THE DEVICE AN ERROR CODE RELATED TO FLOW VERIFICATION 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 25028176 ↗
• 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. DURING THE EVALUATION AND FUNCTIONAL TESTING OF THE DEVICE AN ERROR CODE RELATED TO FLOW VERIFICATION 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 25027793 ↗
• 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. DURING THE EVALUATION AND FUNCTIONAL TESTING OF THE DEVICE AN ERROR CODE RELATED TO PRESSURE AND FLOW VERIFICATION 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 25027656 ↗
• 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. DURING THE EVALUATION AND FUNCTIONAL TESTING OF THE DEVICE AN ERROR CODE RELATED TO FLOW VERIFICATION 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 25027653 ↗
• 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. DURING THE EVALUATION AND FUNCTIONAL TESTING OF THE DEVICE AN ERROR CODE RELATED TO O2 FLOW AND FLOW VERIFICATION 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 25027651 ↗
• MalfunctionApr 28, 2026Failure to Power Up

  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 OF THE DEVICE IT WAS IDENTIFIED THAT THE DEVICE WOULD NOT POWER ON. THE DEVICE COULD NOT BE TESTED. 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 25017036 ↗