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

Model Number	EU2110X15B
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Failure to Calibrate (2440)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A trilogy evo ventilator was reported to have active exhalation control module (aecm) test failure.There was no harm or injury reported.On device evaluation, it was confirmed the valve, proportional (aecm) and valve, three-way solenoid required replacement to address the aecm test failure.After repair, all necessary checks have been carried out to certify the restoration to the conditions prior to the failure.
Additional Manufacturer Narrative
The alleged failed components were evaluated by the product investigation laboratory with the following findings: pil received a trilogy evo proportional valve with the allegation of component failure.Pil installed the trilogy evo proportional valve on the trilogy evo stb and then tested the proportional valve on the pil trilogy evo multifunctional test station for aecm verification at pretest and aecm verification at posttest and passed all testing.Pil concluded that the proportional valve operates as designed.The trilogy evo proportional valve has been scrapped.Pil received a trilogy evo solenoid valve with the allegation of component failure.Pil installed the trilogy evo solenoid valve on the trilogy evo stb and then tested the solenoid valve on the pil trilogy evo multifunctional test station for aecm verification and aecm solenoid current verification at pretest and aecm verification at posttest and passed all testing.Pil concluded that the solenoid valve operates as designed.The trilogy evo solenoid valve has been scrapped.

• Brand Name: TRILOGY
• 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: 23544467
• Report Number: 2518422-2025-111792
• Device Sequence Number: 9449470
• Product Code: CBK
• UDI-Device Identifier: 00606959054981
• UDI-Public: (01)00606959054981
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2026

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
• Device Model Number: EU2110X15B
• Device Catalogue Number: EU2110X15B
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2025
• Supplement Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2020
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown