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

Model Number	GB2110X15B
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Failure to Calibrate (2440); 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 failed pneumatic testing.There was no harm or injury reported.The device has been returned to a third-party service center for evaluation.The evaluation has not yet been performed.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 failed pneumatic testing.There was no harm or injury reported.The device was evaluated by a third-party service center.Alarm conditions indicating a hard and soft power failure and depleted power sources were observed in the device's downloaded event log.The device's battery was recharged to address the issues.A pressure sensor mismatch alarm was observed, and the device's machine flow sensor was replaced to address the issue.The pneumatic test was performed and passed testing.During final testing the device failed a test step for fio2 sensor receptacle verification.This test step verifies that the fio2 solenoid is open, and the tubing is not kinked or occluded.This fio2 sensor is used for monitoring purposes only.This would not affect the device's ability to deliver therapy as designed.The device's fio2 tubing was replaced to address the issue.Final testing was performed, and the device passed all 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: 23696902
• Report Number: 2518422-2025-112212
• Device Sequence Number: 13059807
• 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: 12/09/2025
• 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