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

Model Number	GB2110X15B
Medical Device Problem Codes	Circuit Failure (1089); Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information of a service required for a trilogy evo, great britain device.There was no harm or injury reported.The device was not in patient use.During the evaluation of the trilogy evo, great britain device at third-party service center, an error indicating that either the backlight in display or the communication to the touchscreen failed was discovered in the event log.The device's display board was replaced to address the issue.Additionally, unrelated to the malfunction, the device's detachable battery was not returned with the device; however, it should be replaced to address an evt_detach_batt_wake_volt_failed error.The system board needs to be replaced to address an evt_cal_data error.The device's cooling fan needs to be replaced to address an evt_fan1_failure error.An additional error, evt_sw_upgrade_failure, was documented during evaluation without a definitive component identified for replacement.The device's air inlet foam filter, particulate filter, and muffler assembly need to be replaced to meet the four-year preventative maintenance requirement.The device has been serviced, inspected, tested, and has met acceptance criteria in accordance with all applicable customer requirements.

• Brand Name: TRILOGY EVO, GREAT BRITAIN
• 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: 24637715
• Report Number: 2518422-2026-009752
• Device Sequence Number: 13222210
• Product Code: CBK
• UDI-Device Identifier: 00606959054127
• UDI-Public: (01)00606959054127
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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
• Report Date (Section B): 03/19/2026

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/05/2021
• 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