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

Model Number	EE2110X15B
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	06/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging "fan not working" on a trilogy evo, eastern europe device.There was no harm or injury reported.The device was not in patient use.During the evaluation of the trilogy evo, eastern europe device at the third-party service center, a ventilator inoperative evt_mach_flow_drift_high error was discovered in the device's event log.The device's machine flow sensor was replaced to address the issue.However, when the technician started the unit, a red screen with the message "vent inop" appeared and would not clear even after multiple attempts to upgrade the system board.The device's system board was replaced to address the issue.Additionally, the device's blower has been replaced to address an evt_mcl_foc_shutdown error discovered in the event log.One of the in-line filters was replaced due to contamination.The air foam inlet filter, particulate filter and muffler were replaced due to the 4-year pm procedure.This device has been serviced, inspected, tested, met acceptance criteria in accordance with all of the applicable customer requirements.

• Brand Name: TRILOGY EVO, EASTERN EUROPE
• 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: 23359476
• Report Number: 2518422-2025-111232
• Device Sequence Number: 21104829
• Product Code: CBK
• UDI-Device Identifier: 00606959055544
• UDI-Public: (01)00606959055544
• Combination Product (Y/N): N
• Initial Reporter Country: LO
• PMA/510(K) Number: K181166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/22/2025

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
• Device Model Number: EE2110X15B
• Device Catalogue Number: EE2110X15B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2025
• Initial Report FDA Received Date: 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/23/2021
• 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