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

Model Number	GB2110X15B
Medical Device Problem Codes	Failure to Calibrate (2440); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a calibration failure for a trilogy evo, great britain device, however, there was no information or documentation of any reportable calibration failure.There was no harm or injury reported.The device was not reported to be in patient use.During the evaluation of the trilogy evo, great britain device at third-party service center, it is documented that the machine flow sensor fails the pneumatic test.The device's machine flow sensor has been replaced to address the issue.Additionally, there are no significant errors found in the device log.One in-line filter prox has been replaced due to contamination.The device's blower is corroded and has been replaced.Due to the 4-year preventive maintenance, the muffler assembly, particulate filter, maintenance label and air inlet foam filter were replaced.It is documented that the display was damaged, but there is no information to the extent or type of damage.The display was replaced.

• 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: 23684629
• Report Number: 2518422-2025-112184
• Device Sequence Number: 15904513
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/01/2025

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2025
• Initial Report FDA Received Date: 12/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/04/2021
• 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