Trilogy 200 Trilogy200, Ventilator, Bluetooth, InternationalRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00606959026360), received between Nov 29, 2017 and Apr 23, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Calibration Problem” (2 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 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. A TRILOGY 200 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 TO POWER ON. THE DEVICE WAS REQUESTED TO RETURN UNREPAIRED TO THE CUSTOMER. THE SOUND ABATEMENT FOAM WAS REPLACED PREVENTATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24973426 ↗
• MalfunctionApr 9, 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. A TRILOGY 200 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 FOR LOW O2 FLOW. THE DEVICE WAS REQUESTED TO RETURN UNREPAIRED TO THE CUSTOMER. THE SOUND ABATEMENT FOAM WAS REPLACED PREVENTATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24829802 ↗
• MalfunctionApr 9, 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. A TRILOGY 200 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 FOR LOW O2 FLOW. THE DEVICE WAS REQUESTED TO RETURN UNREPAIRED TO THE CUSTOMER. THE SOUND ABATEMENT FOAM WAS REPLACED PREVENTATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24829799 ↗
• MalfunctionMar 26, 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. A TRILOGY 200 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 COULD NOT BE TESTED DUE TO VENTILATOR INOPERATIVE ALARM CONDITION INDICATING A MOTOR FAILURE WAS OBSERVED. THE DEVICE WAS REQUESTED TO RETURN UNREPAIRED TO THE CUSTOMER. THE SOUND ABATEMENT FOAM WAS REPLACED PREVENTATIVELY. THE CAPA PROCESS IDENTIFIED COMPLAINTS NOT BEING CREATED FOR QUALITY ISSUES FOUND DURING THIRD PARTY SERVICING. BASED ON A REVIEW OF RECORDS IMPACTED BY THE IDENTIFIED ISSUE, IT WAS DETERMINED THAT THIS RECORD NEEDED TO BE CORRECTED AND IS NOW BEING SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24702354 ↗
• MalfunctionMar 4, 2026Degraded

  A TRILOGY 200 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 24510051 ↗
• MalfunctionJul 29, 2025Degraded; Degraded

  A TRILOGY 100 VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO REPORTED PATIENT INVOLVEMENT. DURING THE EVALUATION AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED, AND FOAM PARTICLES WERE OBSERVED. THE DEVICE WAS REMEDIATED, AND THE FOAM INSULATION WAS REPLACED TO RESOLVE THE ISSUE. ADDITIONAL FINDINGS NOT RELATED TO THE MALFUNCTION/ISSUE MISSING RUBBER FEET, HANDLE O-RINGS, AND THE RIGHT BUTTON OF THE KEYPAD'S COATING WAS WORN. THERE WAS DUST FOUND ON THE BLOWER BOX BY THE THIRD-PARTY SERVICE TECHNICIAN. THE CUSTOMER REQUESTED THAT THE UNIT BE RETURNED UNREPAIRED. NO FURTHER INVESTIGATION IS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22648269 ↗
• MalfunctionOct 24, 2018No Display/Image; No Display/Image

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR'S LCD SCREEN WAS BLANK. THE DEVICE WAS NOT IN PATIENT USE. THE DEVICE WAS EVALUATED AT THE MANUFACTURER'S SERVICE CENTER AND THE CUSTOMER'S COMPLAINT WAS CONFIRMED. THE DEVICE'S LCD SCREEN WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 7999472 ↗
• MalfunctionFeb 21, 2018Incorrect Or Inadequate Test Results; Device Displays Incorrect Message; Incorrect Or Inadequate Test Results; Device Displays Incorrect Message

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE DEVICE FAILED A TEST STEP DURING TESTING. THE DEVICE'S ACTIVE EXHALATION CONTROL MODULE WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 7285213 ↗
• MalfunctionNov 29, 2017Device Operational Issue; Device Operational Issue

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THE DEVICE WAS NOT IN PATIENT USE. 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 WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 7066830 ↗