Trilogy 100 Trilogy 100 W/ Bluetooth, USARecalls & reported problems

Summary

The FDA's MAUDE database contains 4,569 adverse event reports that list this exact device (DI 00606959026353), received between Mar 9, 2016 and Sep 30, 2026 — classified as 65 deaths, 288 injuries, 4,215 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (838 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 4,569 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951901 ↗
• MalfunctionSep 30, 2026Circuit Failure; Failure to Calibrate

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951009 ↗
• MalfunctionSep 30, 2026Computer Software Problem; Failure to Calibrate

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949241 ↗
• MalfunctionSep 30, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948995 ↗
• MalfunctionSep 30, 2026Failure to Power Up

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948693 ↗
• MalfunctionSep 30, 2026Failure to Power Up

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948387 ↗
• MalfunctionSep 30, 2026Circuit Failure; Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948379 ↗
• MalfunctionSep 30, 2026Electrical /Electronic Property Problem

  A Trilogy 100 Ventilator device was returned to a third-party service center for service. There is no allegation of serious or permanent harm or injury. The device was not in use on a patient at the time of the occurrence. During the evaluation, the service technician observed R Ventilator Inoperative error code E009. (ERR_DSP_MOTOR_FAILURE) in the error log. No documentation of a replaced component to address the issue.Additionally, no visible foam particles were identified. The device was scrapped; therefore, no additional repair information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948176 ↗
• MalfunctionSep 30, 2026Mechanical Problem; Calibration Problem

  A Trilogy 100 Ventilator device was returned to a service center for service for recertification. There is no allegation of serious or permanent harm or injury. The device was not in use on a patient at the time of the occurrence. During the evaluation of the device, the device failed the Active Exhalation Purge Valve Closed test step. The service technician replaced the AECM (Active Exhalation control module) to correct the issue. Additionally, the rubber feet, labels, front enclosure overlay, and cord retainer needed to be replaced. The device passed final testing.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948175 ↗
• MalfunctionSep 30, 2026Electrical /Electronic Property Problem; Battery Problem

  A Trilogy 100 Ventilator device was returned to a service center for service. There is no allegation of serious or permanent harm or injury. The device was not in use on a patient at the time of the occurrence.During the evaluation, the service technician observed an R VENTILATOR SERVICE REQUIRED error code E193 (ERR_PERM_FAIL_INT_LI_ION) in the error log. This error is an Internal Li-Ion Battery Permanent Failure, and failure of internal battery may impact therapy. The internal battery was found to be faulty and needed to be replaced.Additionally, the rubber feet were missing, the handle was cracked, and the device had an additional R VENTILATOR SERVICE REQUIRED error code E290 (ERR_URGENT_REMINDER). The device was disqualified from recertification due to the system and Central Processing Unit (CPU) board. The device was scrapped and no repairs were completed. Device logs were not available; therefore, the date of the most recent error codes occurrence could not be determined. At this time, the reported error code event date is based solely on the customer's information received and has not been confirmed through device evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948172 ↗
• MalfunctionSep 30, 2026Failure to Calibrate; Power Problem

  The Trilogy 100 was returned to the manufacturer service center for service. There was no serious patient harm or injury that occurred or was reported. There was no allegation of device malfunction. The device was not in patient use.During the evaluation of the device at the service center, the device failed a VAC Power Source test step. The Power Management Board was replaced to address the test step failure. The device passed all testing during the retesting.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947867 ↗
• MalfunctionSep 30, 2026No Display/Image

  A Trilogy 100 Ventilator, U.S.A - BT device was returned to a third-party service center for evaluation. There was no allegation of device malfunction, and the device was not reported to have been in patient use.During evaluation of the device, the service technician confirmed that there was a blank screen. The device evaluation does not identify any specific component malfunction that would need to be replaced to resolve the blank screen issue.Additionally, the service technician found that there were no visible foam particles, and the error codes were unretrievable. After the evaluation was complete, the device was scrapped.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947058 ↗
• MalfunctionSep 30, 2026Electrical /Electronic Property Problem; Battery Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946586 ↗
• MalfunctionSep 30, 2026No Display/Image; Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946425 ↗
• MalfunctionSep 30, 2026Mechanical Problem; Failure to Calibrate

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946417 ↗
• MalfunctionSep 30, 2026Battery Problem

  A Trilogy 100 was returned to the manufacturer for service. There was no serious patient harm or injury that occurred or was reported. There was no allegation of device malfunction. The device was not reported to be in patient use.During the evaluation of the device at the manufacturer's service center, an error code related to the internal battery was observed. ERR_PERM_FAIL_INT_LI_ION means there was an internal Li-Ion battery permanent failure. The device's internal battery needs replaced to address the issue. No repairs made and device was scrapped.Additionally, during the evaluation of the device at the manufacturer's service center, the device failed a non-reportable test step during testing. The Check Internal Battery Capacity test checks if the battery is charged to a particular level required by the test, it does not affect therapy. Also, the device was found to have missing/displaced rubber feet and a damaged keypad. No repairs made and device was scrapped.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50945975 ↗
• MalfunctionSep 28, 2026Mechanical Problem; Failure to Calibrate

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50922507 ↗
• MalfunctionSep 28, 2026Calibration Problem; Adverse Event Without Identified Device or Use Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50921550 ↗
• MalfunctionSep 28, 2026Electrical /Electronic Property Problem; Battery Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50915228 ↗
• MalfunctionSep 28, 2026Electrical /Electronic Property Problem

  A Trilogy 100 Ventilator, U.S.A - BT device was returned to a third-party service center for evaluation. There was no report of patient harm or injury.During the evaluation, the service technician noted error ERR_INT_LI_ION_NOT_PRESENT (error code 197) in the device error code log. The device evaluation does not identify any specific component malfunction that would need to be replaced to resolve these error codes.Additionally, the service technician confirmed that there were no visible foam particles. After the evaluation was complete, the device was scrapped.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50915227 ↗
• MalfunctionSep 28, 2026Circuit Failure; Failure to Calibrate

  A Trilogy 100 was returned to the manufacturer for service. There was no serious patient harm or injury that occurred or was reported. There was no allegation of device malfunction. The device was not reported to be in patient use.During the evaluation of the device at the manufacturer's service center, the device failed a Nurse Call test step during testing. The device's interface board was replaced to address the issue.Additionally, during the evaluation of the device at the manufacturer's service center, non-reportable damage was found to the device. The device was found to have missing/displaced rubber feet, the cord retainer was missing/broken, a keypad button was damaged, the front case enclosure was damaged, the rear case enclosure was damaged, the handle was cracked and the active exhalation control module was cracked.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50913691 ↗
• MalfunctionSep 25, 2026Circuit Failure; Failure to Calibrate

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50903050 ↗
• MalfunctionSep 25, 2026Electrical /Electronic Property Problem

  A Trilogy100 Ventilator, U.S.A., was returned to a third-party service center for routine preventive maintenance. There was no allegation of device malfunction, and the device was not reported to have been in patient use.During evaluation at the third-party service center, an error code 195- ERR_BATT_LOW_STATE_OF_HEALTH_INT_LI_ION was observed, indicating that the internal battery failed to charge. The evaluation did not identify a specific component malfunction requiring replacement to restore device functionality. The device logs were not available; therefore, the date of occurrence of the most recent error code could not be determined. At this time, the reported error code event date is based solely on information received from the customer and has not been confirmed through device evaluation. No root cause was established. No repair was performed, and the device was marked as scrap. Additionally, the device had a non-actionable error code 290- VENTILATOR SERVICE REQUIRED and Visual inspection found no evidence of foam degradation, and no foam particles were observed during the evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50900167 ↗
• MalfunctionSep 25, 2026Electrical /Electronic Property Problem

  The manufacturer received information alleging a cell undervoltage error code was observed on a Trilogy 100 device. The device was not in use on a patient at the time of the occurrence. During the evaluation it was noted that an error code, cell undervoltage, was observed on the device's error log. The service technician provided no documentation stated on a root cause and/or any component replacement to resolve the cell undervoltage error code. There was no repair information was provided, and no part(s) were replaced to address this issue. A final report is being submitted. If new information becomes available following the completion of the device repair that changes the outcome of the investigation and associated medical device reporting a supplemental report will be completed. The root cause isn't confirmed at this time.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899425 ↗
• MalfunctionSep 25, 2026Electrical /Electronic Property Problem

  The manufacturer received information alleging two ventilator service required error codes were observed on a Trilogy 100 device. The device was not in use on a patient at the time of the occurrence. During the evaluation it was noted that an error codes, error perm fail int li ion and cell undervoltage, were observed on the device's error log. The third-party service technician provided no documentation stated on a root cause and/or any component replacement to resolve the error perm fail int li ion error code. There was no repair information was provided, and no part(s) were replaced to address this issue. The device will be scrapped. The root cause isn't confirmed at this time. A visual inspection found no evidence of foam degradation, and no foam particles were observed during the evaluation.A final report is being submitted. If new information becomes available following the completion of the device repair that changes the outcome of the investigation and associated medical device reporting a supplemental report will be completed.Additionally, during the service of the device, another error code, event urgent reminder, was observed on the device's error log. The third-party se

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899203 ↗