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

Model Number	GB2110X15B
Medical Device Problem Codes	Circuit Failure (1089); Contamination (1120); Electrical /Electronic Property Problem (1198); Mechanical Problem (1384); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a ventilator was continuously alarming for a pressure sensor mismatch alarm condition.There was no harm or injury reported.The device was not in patient use.The device has been sent to a third-party service center for evaluation.The evaluation has not yet begun.If any additional information is received once the evaluation is complete, a follow-up report will be filed.
Additional Manufacturer Narrative
The manufacturer previously reported a ventilator was continuously alarming for a pressure sensor mismatch alarm condition.There was no harm or injury reported.The device was not in patient use.The device was returned to a third-party service center for evaluation.The pressure sensor mismatch alarm was confirmed.The repair recommended was to inspect the air pathway for environmental debris or contamination and if present replace the air pathway components.The device's particulate filter, filter cover, air inlet foam filter, blower assembly, blower bellws seal, blower mount, proportional valve, blower cap, dual limb cup, machine flow sensor, blower chassis plate, system board tubing, blower chassis tubing, fio2 tubing, low flow o2 tubing, three-way solenoid valve, low flow o2 connector, outside panel, fio2 housing, muffler assembly and system board need to be replaced.No repairs were performed.The device was scrapped per the customer's request.

• 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: 23694573
• Report Number: 2518422-2025-112209
• Device Sequence Number: 13355974
• 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): 12/12/2025

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
• Device Model Number: GB2110X15B
• Device Catalogue Number: GB2110X15B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2025
• Supplement Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/22/2021
• 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