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

Model Number	BL2110X15B
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Mechanical Problem (1384); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information a trilogy evo ventilator was returned to the manufacturer's service center for the report of a ventilator service required error code e-384, which indicates the device software has detected 320788247.There no harm or injury reported.The device has not yet been returned to the manufacturer for evaluation.At this time, the manufacturer is unable to confirm the alleged malfunction.If additional information is received, a follow-up report will be filed.
Additional Manufacturer Narrative
The manufacturer received information a trilogy evo ventilator was returned to the manufacturer's service center for the report of a ventilator service required error code e-384, which indicates the device software has detected a large pressure drop between the monitor and outlet pressure sensors.The trilogy evo ventilator was returned to the third-party service center for evaluation.On evaluation, error code e-384 occurred due to contaminated components inside the ventilator.The machine flow sensor and the muffler assembly were contaminated and required replacement.Additional findings not related to the malfunction/issue: the air inlet foam filter required replacement as part of preventative maintenance.The system printed circuit board assembly required replace due to non-critical error codes indicating the internal battery was in use and the sensor offset during drift calculation was too high.This device has been serviced, inspected, tested, met acceptance criteria in accordance with all of the applicable customer requirements.
Additional Manufacturer Narrative
It was previously reported: the manufacturer received information a trilogy evo ventilator was returned to the manufacturer's service center for the report of a ventilator service required error code e-384, which indicates the device software has detected a large pressure drop between the monitor and outlet pressure sensors.The trilogy evo ventilator was returned to the third-party service center for evaluation.On evaluation, error code e-384 occurred due to contaminated components inside the ventilator.The machine flow sensor and the muffler assembly were contaminated and required replacement.Additional findings not related to the malfunction/issue: the air inlet foam filter required replacement as part of preventative maintenance.The system printed circuit board assembly required replace due to non-critical error codes indicating the internal battery was in use and the sensor offset during drift calculation was too high.This device has been serviced, inspected, tested, met acceptance criteria in accordance with all of the applicable customer requirements.The coding grid has been updated with this correction to more accurately align with the evaluation findings reported.

• 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: 23569722
• Report Number: 2518422-2025-111861
• Device Sequence Number: 9868589
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/12/2026

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: 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: 11/04/2025
• Supplement Date Received by Manufacturer: 12/11/2025; 02/12/2026
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 12/11/2025; 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/19/2023
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown