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

Model Number	BL2110X15B
Medical Device Problem Codes	Contamination (1120); Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2025
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.The trilogy evo (benelux) device has not yet been returned to the manufacturer for evaluation.The manufacturer's investigation is ongoing.A supplemental report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The manufacturer previously reported information received 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 trilogy evo (benelux) device at the third-party service center, an evt_press_sensor_mismatch error indicating the device software has detected a large pressure drop between the monitor and outlet pressure sensors discovered in the event log.The technician documented that the error is caused by the contamination of one in-line filter prox.Additionally, the device's the muffler assembly, particulate filter and air inlet foam filter need to be replaced, for the 4-year preventive maintenance requirements.A final report is being submitted.If new information becomes available following the completion of the device repair that changes the outcome of the investigation and associated medical device reporting a follow up/supplemental report will be completed.

• 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: 22979718
• Report Number: 2518422-2025-109749
• Device Sequence Number: 13148874
• 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,Followup
• Report Date (Section B): 10/13/2025

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2025
• Supplement Date Received by Manufacturer: 10/01/2025
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/12/2021
• 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