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

Model Number	EE2110X15B
Medical Device Problem Codes	Circuit Failure (1089); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information a trilogy evo "device failed.Unknown fault.Red display".There was no harm or injury reported.The device was not in patient use.The device has been returned to a third-party service center, but evaluation has not yet begun.The manufacturer's investigation is ongoing.A supplemental report will be submitted when the service center's investigation is complete.
Additional Manufacturer Narrative
The manufacturer previously reported information received that a trilogy evo "device failed.Unknown fault.Red display".There was no harm or injury reported.The device was not in patient use.The trilogy evo, eastern europe device was evaluated by a third-party service center.During the evaluation of the device the technician documented that the "red display" appeared due to system board failure and needs to be replaced.Additionally, the replacement of the device's system board was necessary due to a debug error indicating the sensor offset during drift calculation is too high, and pneumatic test group was performed and failed the test.The device's vanity cover need to be replaced due to mismatched information.The muffler, particulate filter and air foam filter need to be replaced, due to 4 years preventive maintenance.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
• 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: 22754671
• Report Number: 2518422-2025-108908
• Device Sequence Number: 8716242
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2025

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/08/2025
• Supplement Report FDA Received Date: 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/07/2022
• 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