Trilogy U1054260BRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00606959028944), received between Oct 1, 2021 and May 15, 2026 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Failure to Recalibrate” (6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2026Failure to Charge

  THE MANUFACTURER RECEIVED INFORMATION THAT A TRILOGY 100 WAS REPORTED TO HAVE RECEIVED AS PART OF ADVANCED EXCHANGE. THE REPORTER STATED UPON RECEIPT, THE CUSTOMER REPORTED THAT THE LIGHT TO SHOW THE UNIT IS CHARGING WAS NOT COMING ON. THERE WAS ALSO AN ODOR OF URINE WITH THE DEVICE. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S SERVICE CENTER FOR EVALUATION. THERE WAS NO PATIENT INVOLVEMENT, AND NO HARM OR INJURY REPORTED. ON DEVICE EVALUATION, THE DEVICE WAS PLUGGED IN TO ALTERNATING CURRENT POWER AND THE DEVICE WOULD NOT CHARGE AND THE POWER LIGHT WAS CONFIRMED TO NOT TURN ON. DEVICE ERROR CODES IN THE ERROR LOG SHOWED ERROR CODE E-201 INDICATING FAILURE OF THE POWER MANAGEMENT BOARD. AN ADDITIONAL ERROR CODE E-202 WAS NOTED IN THE ERROR LOG INDICATING CIRCUITRY FAILURE. REPLACEMENT OF THE POWER SUPPLY PRINTED CIRCUIT BOARD ASSEMBLY (PCA) IS REQUIRED TO ADDRESS THE NO POWER LIGHT/UNABLE TO CHARGE ISSUE. REPLACEMENT OF THE POWER MANAGEMENT (PCA) ASSEMBLY IS REQUIRED TO ADDRESS THE FAILURE OF THE POWER MANAGEMENT PCA AS INDICATED BY THE OCCURRENCE OF ERROR CODE E-201. THE SYSTEM PCA WOULD NEED TO BE REPLACED TO ADDRESS THE CIRCUITRY FAILURE REPRESENTED BY ERROR CODE E-202. NO REPA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25181834 ↗
• MalfunctionSep 19, 2025Failure to Recalibrate; Failure to Recalibrate

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE DEVICE FAILED A TEST STEP FOR ACTIVE EXHALATION VALVE OPENED - CLOSED DURING TESTING. THE DEVICE'S ACTIVE EXHALATION CONTROL MODULE WAS PLUGGED IN AND THE UNIT WAS REASSEMBLED. THE DEVICE PASSED ALL THE TESTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23097574 ↗
• MalfunctionJul 16, 2025Failure to Recalibrate; Failure to Recalibrate

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR ROUTINE PREVENTATIVE MAINTENANCE. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. THERE WAS NO HARM OR INJURY REPORTED. 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 NEEDS TO BE REPLACED TO ADDRESS THE ISSUE. NO REPAIR PERFORMED DUE TO THE DEVICE NOT NEEDED FOR INVENTORY. THE UNIT WILL BE SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22521241 ↗
• MalfunctionMay 13, 2025Failure to Recalibrate; Failure to Recalibrate

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE DEVICE FAILED A TEST STEP DURING TESTING. PERFORMED INSPECTION FOR OXYGEN FAILURE AND FOUND THAT THE GREY REMOVABLE FOAM WAS NOT CORRECTLY INSTALLED. REINSTALLED FOAM CORRECTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22010961 ↗
• MalfunctionSep 5, 2024Mechanical Problem; Failure to Recalibrate; Mechanical Problem; Failure to Recalibrate

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE INITIAL 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 NEEDS TO BE REPLACED TO ADDRESS THE ISSUE. NO REPAIRS PERFORMED. THE UNIT WILL BE SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20145477 ↗
• MalfunctionSep 5, 2024Mechanical Problem; Failure to Recalibrate; Mechanical Problem; Failure to Recalibrate

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE INITIAL 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 NEEDS TO BE REPLACED TO ADDRESS THE ISSUE. NO REPAIRS PERFORMED. THE UNIT WILL BE SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20145029 ↗
• MalfunctionSep 3, 2024Gas Output Problem; Decrease in Pressure; Gas Output Problem; Decrease in Pressure

  A TRILOGY100 VENTILATOR WAS RETURNED TO THE MANUFACTURER SERVICE CENTER FOR FOAM REPLACEMENT PER FIELD ACTION: C&R 2021-05/06. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER SERVICE CENTER, THE DEVICE POWERED ON AND OPERATED AS IT SHOULD. THE INLET AIR PATH ASSEMBLY AND REMOVABLE AIR PATH FOAM WAS REPLACED PER REMEDIATION. IN ADDITION, THE PM LABEL AND ENCLOSURE FEET WERE REPLACED. THE DEVICE WAS RETURNED TO THE TECHNICIAN FOR FURTHER TESTING. THE DEVICE FAILED A TEST STEP FOR O2 LOW FLOW. THE DEVICE'S ACTIVE EXHALATION CONTROL MODULE NEEDS TO BE REPLACED TO ADDRESS THE ISSUE. NO REPAIRS PERFORMED. THE DEVICE WAS SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20123563 ↗
• MalfunctionAug 22, 2024Degraded; Degraded

  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. THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A TRILOGY 100 DEVICE'S SOUND ABATEMENT FOAM. THE MANUFACTURER RECEIVED INFORMATION ALLEGING VISUALIZATION OF PARTICLES. THERE WAS NO REPORT OF HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20032503 ↗
• InjuryJun 20, 2024Degraded; Degraded

  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. THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A VENTILATOR'S SOUND ABATEMENT FOAM. THE REPORTER ALLEGED OF HAVING DIZZINESS AND/OR HEADACHE, ASTHMA (NEW OR WORSENING), LUNG DISEASE, LUNG CANCER FROM A TRILOGY 100 DEVICE. MEDICAL INTERVENTION WAS NOT SPECIFIED. NO ADDITIONAL INFORMATION CAN BE REQUESTED THIS TIME. THE MANUFACTURER WAS MADE AWARE OF THIS COMPLAINT THROUGH A REPRESENTATIVE OF THE CUSTOMER.  AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: Asthma; Cancer; Dizziness; Headache; Unspecified Respiratory Problem

  MAUDE report 19576947 ↗
• MalfunctionFeb 5, 2024Failure to Recalibrate; Failure to Recalibrate

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. 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 NEEDS TO BE REPLACED TO ADDRESS THE ISSUE. THE DEVICE WAS RETURNED UNREPAIRED PER CUSTOMER REQUEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18638967 ↗
• MalfunctionDec 19, 2022Degraded; Degraded

  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. THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT HAS ALLEGED FILTERS ARE DIRTY. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16010156 ↗
• MalfunctionJul 13, 2022Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING VISUALIZATION OF PARTICLES IN THE AIR PATH. THERE WAS NO REPORT OF SERIOUS PATIENT HARM OR INJURY. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15004096 ↗
• MalfunctionJan 6, 2022Battery Problem; Battery Problem

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR ROUTINE PREVENTIVE MAINTENANCE. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. 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 INTERNAL BATTERY WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13177128 ↗
• MalfunctionOct 1, 2021No Pressure; No Pressure

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR WAS NOT PROVIDING PRESSURE. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12562941 ↗