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

Model Number	AU2110X15B
Medical Device Problem Codes	Computer Software Problem (1112); Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2026
Type of Reportable Event	Malfunction
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.The device was returned to the manufacturer service center evaluation.The manufacture's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
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.The device was returned to the manufacturer service center evaluation.The manufacture's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.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 a 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.

• 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: 24820852
• Report Number: 2518422-2026-010561
• Device Sequence Number: 15860830
• 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: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2026

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: 03/11/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/08/2026
• Supplement Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2022
• 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