MAUDE Adverse Event Report: RESPIRONICS, INC. TRILOGY 202; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	1040007
Medical Device Problem Codes	Circuit Failure (1089); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The trilogy 202 ventilator was returned to the third-party service center for preventative maintenance.The device was not in use on a patient at the time of the occurrence.During the evaluation of the device at the third-party service center an error code in relation to (low flow) was recorded in the device event log and the blender gasket leak occurred.In conclusion the system board and oxygen blender gasket kits were replaced to address the issues.The root cause is confirmed at this time.Additionally, during the service of the device, the pollen filter was replaced due to contamination, internal battery pack was replaced due to age, front enclosure overlay was replaced, and the whisper cap was missing and replaced.The service center completed full factory calibration and testing.

• Brand Name: TRILOGY 202
• 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: 24051710
• Report Number: 2518422-2026-001858
• Device Sequence Number: 9421445
• Product Code: CBK
• UDI-Device Identifier: 00606959005150
• UDI-Public: (01)00606959005150
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K093905
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/13/2026

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
• Operator of Device: Other
• Device Model Number: 1040007
• Device Catalogue Number: 1040007
• Device Lot Number: 100630
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/06/2010
• 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