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

Model Number	EU2110X15B
Medical Device Problem Codes	Decrease in Pressure (1490); Loss of Threshold (1633)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging ventilator service required alarm occurred on a trilogy evo while in patient use.There was no report of injury or harm.The customer states a trilogy evo error code indicating (the device software has detected a large pressure drop between the monitor and outlet pressure sensors) was recorded in the event log.The device was sent to a third-party service center for evaluation.If any additional information is received, a follow-up report will be filed.
Additional Manufacturer Narrative
Previously reported by the manufacturer: the manufacturer received information alleging ventilator service required alarm occurred on a trilogy evo while in patient use.There was no report of injury or harm.The customer states a trilogy evo error code indicating (the device software has detected a large pressure drop between the monitor and outlet pressure sensors) was recorded in the event log.The device was sent to a third-party service center for evaluation.If any additional information is received, a follow-up report will be filed.New information/evaluation.The trilogy evo was returned to the third-party service center for evaluation and the customer's complaint of an error code in relation to press_sensor_mismatch was not confirmed.Additionally, during a pre-test, the unit failed a test step due to a machine flow sensor error, unrelated to the alleged malfunction.The machine flow sensor was replaced to address the issue.The air foam inlet filter was replaced due to preventive maintenance.The device passed all test.This device has been serviced, inspected, tested, met acceptance criteria in accordance with all of the applicable customer requirements as defined in the contractual agreement with plexus.The device history record has been reviewed and approved by plexus quality assurance.

• 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: 23308165
• Report Number: 2518422-2025-111057
• Device Sequence Number: 12009170
• Product Code: CBK
• UDI-Device Identifier: 00606959054981
• UDI-Public: (01)00606959054981
• Combination Product (Y/N): N
• Initial Reporter Country: LH
• 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: Other,Foreign,Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2025

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: EU2110X15B
• Device Catalogue Number: EU2110X15B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2025
• Supplement Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/13/2024
• 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