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

Model Number	GB2110X15B
Medical Device Problem Codes	Circuit Failure (1089); Computer Software Problem (1112); Display or Visual Feedback Problem (1184); Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a trilogy evo ventilator experienced an out of box failure due to a screen freeze.There was no serious patient harm or injury that occurred or was reported.During evaluation of the device at the third party service center, a ventilator inoperative error code relating to a 'system version mismatch user interface' was found in the device's error log.The service technician states that the latest software was installed to address the issue.Additionally, the service technician confirmed the out of box failure and stated that the display liquid crystal display (lcd) was not functioning.The display printed circuit assembly (pca) board was replaced to resolve the screen freeze.Additionally, two not-reportable error codes relating to 'inlet filter black' and 'comms fail user interface' were found in the device's error log.The air inlet foam filter was replaced and the replacement of the display pca resolved both of these errors.The device passed testing.

• 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: 24589739
• Report Number: 2518422-2026-009472
• Device Sequence Number: 5662466
• Product Code: CBK
• UDI-Device Identifier: 00606959054127
• UDI-Public: (01)00606959054127
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/13/2026

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
• Operator of Device: Other
• Device Model Number: GB2110X15B
• Device Catalogue Number: GB2110X15B
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/22/2021
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown