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); Electrical /Electronic Property Problem (1198); Failure to Calibrate (2440); Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A corrected report is being filed to address the incorrect become aware date.The initial report was filed with 03/13/2025 as the become aware date and 04/04/2025 as the due date.The correct become aware date is 03/13/2026 and the correct due date is 04/12/2026.The coding has been updated to include the system board failure/replacement.All other reporting information was accurate.
Event or Problem Description
A ventilator was returned to a third-party service center for preventive maintenance.There was no harm or injury reported.The device was not in patient use.During the evaluation an alarm indicating all power sources were depleted was observed in the device's downloaded event log.The device's detachable battery was replaced to address the issue.Additional ventilator inoperative alarms indicating a software mismatch were observed.The device's software was reinstalled to address the issues.The device failed the final shutdown procedure, and the system board was replaced to address the issue.The device was retested and passed all final 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: 24616327
• Report Number: 2518422-2026-009667
• Device Sequence Number: 18538265
• 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: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2026

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
• Device Model Number: GB2110X15B
• Device Catalogue Number: GB2110X15B
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2025
• Supplement Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 03/17/2026
• Supplement Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/08/2019
• 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