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

Model Number	BL2110X15B
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a ventilator service required alarm occurred while the trilogy evo, benelux device was in patient use.There was no allegation of harm or injury reported.During the evaluation of the device at third-party service center, an error indicating the device software detected a large pressure drop between the monitor and outlet pressure sensors discovered in the event log.The root cause of the errors found in log are caused by clogged filters in the unit.The technician replaced the device's flow sensor to address the issue.Additionally, the device's blower assembly, one in-line filter prox assy and in- line filter are contaminated and have been replaced.The connection cover is missing.The device's air foam inlet filter, muffler and particulate filter will be replaced due to the 4 year preventive maintenance procedure.The device has been serviced, inspected, tested, met acceptance criteria in accordance with all of the applicable customer requirements.

• Brand Name: TRILOGY EVO, BENELUX
• 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: 23851725
• Report Number: 2518422-2025-112899
• Device Sequence Number: 13154750
• Product Code: CBK
• UDI-Device Identifier: 00606959055520
• UDI-Public: (01)00606959055520
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 12/19/2025

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: BL2110X15B
• Device Catalogue Number: BL2110X15B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/29/2021
• 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