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

Model Number	FR2110X14B
Medical Device Problem Code	Display Difficult to Read (1181)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging the screen was damaged and unreadable that occurred on a trilogy evo device.The device was not in use on a patient at the time of the occurrence.The trilogy evo was evaluated at the third-party service center.During the evaluation it was noted that there was damaged to the screen and it needs to be replaced.In conclusion, the device's display screen needs replaced to address the issue.There were no repair and/or part(s) replaced on the device since the customer requested the device be scrapped.Additionally, during the service of the device, the particulate filter and air inlet foam filter needs replaced for preventative maintenance unrelated to the reportable malfunction/issue.

• 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: 23309468
• Report Number: 2518422-2025-111053
• Device Sequence Number: 5801617
• Product Code: CBK
• UDI-Device Identifier: 00606959055506
• UDI-Public: (01)00606959055506
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/16/2025

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
• Operator of Device: Other
• Device Model Number: FR2110X14B
• Device Catalogue Number: FR2110X14B
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/24/2023
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown