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

Model Number	ES2110X15B
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information from a customer that a cooling fan noise occurred on a trilogy evo ventilator while in use on a patient.The trilogy evo ventilator was returned to the third-party service center for evaluation; and the customer¿s complaint was confirmed.During the evaluation it was noted that the devices cooling fan and inlet side are both damaged and were replaced to address the issue.Additionally, during the evaluation critical error codes in relation to (therapy central processing unit (cpu) is still running in boot monitor software.) and (soft power fail) were recorded in the device event log.The device passed all functional testing, and no functional defects were found.The air foam inlet filter and particulate filter were replaced for preventative maintenance unrelated to the reportable malfunction/issue.The device passed all final testing.The device has been serviced, inspected, tested, met acceptance criteria in accordance with all of the applicable customer requirements as defined in the contractual agreement with plexus.The device history record has been reviewed and approved by plexus quality assurance.

• 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: 24494500
• Report Number: 2518422-2026-007464
• Device Sequence Number: 18801209
• Product Code: CBK
• UDI-Device Identifier: 00606959054080
• UDI-Public: (01)00606959054080
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/03/2026

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
• Device Model Number: ES2110X15B
• Device Catalogue Number: ES2110X15B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/24/2021
• 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