Trilogy U1040005BRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00606959028876), received between Apr 30, 2025 and Feb 19, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Computer Software Problem” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 19, 2026Computer Software Problem

  THE TRILOGY 200 VENTILATOR WAS RETURNED TO THE MANUFACTURER SERVICE CENTER FOR RECERTIFICATION AND PREVENTATIVE MAINTENANCE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. DURING THE EVALUATION, IT WAS NOTED THAT THE DEVICE RETURNED TO THE TECHNICIAN FOR ADDITIONAL EVALUATION DUE TO A FAILED REPAIR TEST (POS. FLOW VERIFY). THE DEVICE WAS RECALIBRATED TO RESOLVE THE ISSUE. THERE WERE NO SIGNIFICANT EVENT(S) IN THE ERROR LOG(S). ADDITIONALLY, DURING THE SERVICE OF THE DEVICE, COMPONENTS WERE ONLY REPLACED AS PART OF MAINTENANCE OF THE DEVICE. THE DEVICE PASSED ALL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24388200 ↗
• MalfunctionFeb 4, 2026Failure to Calibrate; Improper Flow or Infusion

  A TRILOGY 200 VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE DEVICE FAILED THE POSITIVE FLOW VERIFY TEST STEP DURING TESTING. THE DEVICE'S ACTIVE EXHALATION CONTROLLER WAS REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, UNRELATED TO THE TEST FAILURE, DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE DEVICE WAS FOUND TO HAVE MISSING/DISPLACED RUBBER FEET. FEET WERE REPLACED TO ADDRESS THE ISSUE. ALSO, DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE DEVICE FAILED THE NON-REPORTABLE INTERNAL BATTERY CAPACITY TEST STEP DURING TESTING. THE INTERNAL BATTERY PACK WAS CHARGED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24260202 ↗
• MalfunctionApr 30, 2025Failure to Power Up; Failure to Power Up

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A TRILOGY 200 FAILED INITIAL POWER UP. THERE WAS NO HARM OR INJURY REPORTED. THE VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND THE CUSTOMER¿S COMPLAINT WAS CONFIRMED. THE DEVICE'S POWER MANAGEMENT BOARD REQUIRED REPLACEMENT TO ADDRESS THE ISSUE. HOWEVER, NO REPAIRS WERE COMPLETED BECAUSE THE DEVICE WAS NOT NEEDED FOR INVENTORY AND WAS SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21935872 ↗