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

Model Number	FR2110X14B
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a damaged screen on a trilogy evo device.The device was not in use on a patient at the time of the occurrence.The trilogy evo device was returned to a third-party service center for evaluation, and the customer¿s complaint was confirmed.During the evaluation, the third-party service technician did not provide any findings on the cause of the damage display for this device.In conclusion, the device's display screen was replaced to address the issue.Additionally, during the service of the device, the inline filter was replaced for contamination unrelated to the reportable issue.The air foam inlet filter, particulate filter, and muffler were replaced for preventative maintenance unrelated to the reportable issue.The device passed all final testing.
Additional Manufacturer Narrative
Correction: upon further review of this record, it was found to be non-reportable.Based on the information available, there is not enough evidence to indicate a reportable malfunction occurred or that therapy was affected.No report will be filed with any regulatory agencies at this time.If upon evaluation of the device a reportable issue/malfunction is identified, this decision will be re-evaluated using the date of the repair evaluation as the "become aware" date.

• 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: 23760777
• Report Number: 2518422-2025-112434
• Device Sequence Number: 10079488
• 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): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2025

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: 11/11/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/13/2021
• 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