Trilogy R1054260BRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00606959028906), received between Oct 14, 2020 and Apr 30, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Battery 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 30, 2025Failure to Power Up; Failure to Power Up

  A TRILOGY 100 VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THERE WAS NO REPORTED PATIENT INVOLVEMENT. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE DEVICE DID NOT POWER ON AND OPERATE AS IT SHOULD. AN INITIAL POWER UP ERROR OCCURRED. THE MANUFACTURER'S SERVICE TECHNICIAN RECOMMENDED REPLACING THE DEVICE'S POWER MANAGEMENT BOARD TO ADDRESS THE ISSUE. NO REPAIR WAS PERFORMED. THE DEVICE IS NOT NEEDED FOR INVENTORY AND WAS SCRAPPED. NO FURTHER INVESTIGATION IS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21936435 ↗
• MalfunctionNov 17, 2024Battery Problem; Battery Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR WAS ALARMING FOR A "CRITICAL ERROR". THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, A "SERVICE REQUIRED" ALARM CONDITION RELATED TO THE INTERNAL BATTERY WAS OBSERVED. THE DEVICE'S INTERNAL BATTERY NEEDS TO BE REPLACED TO ADDRESS THE ISSUE. NO REPAIRS WERE PERFORMED. THE DEVICE WAS SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20702025 ↗
• MalfunctionDec 23, 2020No Display/Image; No Display/Image

  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'S LCD SCREEN WAS UNABLE TO BE VIEWED DUE TO PHYSICAL DAMAGE. THE LCD SCREEN WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11064334 ↗
• MalfunctionOct 14, 2020Failure to Recalibrate; Failure to Recalibrate

  A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR ROUTINE PREVENTATIVE MAINTENANCE. THERE WAS NO HARM, OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE DEVICE FAILED TEST STEPS DURING TESTING. THE ACTIVE EXHALATION CONTROL MODULE WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10679402 ↗