MAUDE Adverse Event Report: RESPIRONICS, INC. TRILOGY EVO; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	AU2110X15B
Medical Device Problem Codes	Circuit Failure (1089); Operating System Version or Upgrade Problem (2997); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Previously reported by the manufacturer: the manufacturer received information stating a trilogy evo ventilator inoperative condition occurred during a failed firmware update.The device was not in use on a patient at the time of the occurrence.During the evaluation of the device, the system board was replaced, and all ventilator settings were replaced with the work ¿value¿ to address the issue.The root cause was confirmed.Correction: during the evaluation of the device, the system board, and all ventilator settings were replaced with the work ¿value¿ to address the issue.Philips is currently investigating this complaint to determine the root cause of the failure.As a part of the complaint handling process, good faith effort attempts will be made to gather additional information.
Event or Problem Description
The manufacturer received information stating a trilogy evo ventilator inoperative condition occurred during a failed firmware update.The device was not in use on a patient at the time of the occurrence.During the evaluation of the device, the system board was replaced, and all ventilator settings were replaced with the work ¿value¿ to address the issue.The root cause was confirmed.
Additional Manufacturer Narrative
Previously reported by the manufacturer: the manufacturer received information stating a trilogy evo ventilator inoperative condition occurred during a failed firmware update.The device was not in use on a patient at the time of the occurrence.During the evaluation of the device, the system board was replaced, and all ventilator settings were replaced with the work ¿value¿ to address the issue.The root cause was confirmed.Correction: during the evaluation of the device, the system board, and all ventilator settings were replaced with the work ¿value¿ to address the issue.Philips is currently investigating this complaint to determine the root cause of the failure.As a part of the complaint handling process, good faith effort attempts will be made to gather additional information.New information/ correction: this notification has been reviewed for information received that after a repair/service software upgrade was attempted on a trilogy evo the device became inoperative.This information does not indicate a malfunction of the device, yet a result of the service being provided.It has been concluded that the trigger for this condition would not occur during normal operation and use on a patient; therefore, posing no additional safety risk for a patient.Based on the available information, there is not enough evidence to suggest if this reported issue were to recur that it would be likely to cause or contribute to death or serious injury.No report will be filed with any regulatory agencies at this time.At this time the reported failed software update does not produce an increased patient safety risk.All patients must be taken- off from the devices and put on alternative device prior to sw update process.To date no patient harm has been reported during a failed software update, and all devices were not in use.This concludes this event is not reportable.Box h coding updated.

• Brand Name: TRILOGY EVO
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer Contact: melissa rosko ; 1001 murry ridge lane; murrysville, PA ; 7247330200
• MDR Report Key: 24651798
• Report Number: 2518422-2026-009849
• Device Sequence Number: 9760581
• Product Code: CBK
• UDI-Device Identifier: 00606959051980
• UDI-Public: (01)00606959051980
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K181166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/17/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: AU2110X15B
• Device Catalogue Number: AU2110X15B
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2026
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 03/23/2026; 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/12/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown