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

Model Number	TR2110X15B
Medical Device Problem Codes	Circuit Failure (1089); Electrical /Electronic Property Problem (1198); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a patient experienced a ventilator service required alarm while using a trilogy evo device.There was no allegation of serious or permanent harm or injury.No medical intervention was specified by the patient.The trilogy evo device was returned to the manufacturer service center for evaluation, and the customer¿s complaint was confirmed.During the evaluation it was noted that an error code, pressure sensor mismatch (e-384), was observed in the device's error log.The manufacturer's service technician determined there was a leak in the airway had caused the issue to occur on the device.In conclusion, the device's blower cap, blower bellows, in-line filter, in-line proximal filters, machine flow sensor, muffler assembly, proportional valve, three-way solenoid valve, and system printed circuit assembly board were replaced to address the issue.The root cause is confirmed at this time.

• 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: 23304229
• Report Number: 2518422-2025-111042
• Device Sequence Number: 10193051
• Product Code: CBK
• UDI-Device Identifier: 00606959055551
• UDI-Public: (01)00606959055551
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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
• Report Date (Section B): 10/15/2025

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: TR2110X15B
• Device Catalogue Number: TR2110X15B
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2025
• Initial Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2023
• 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