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

Model Number	CA1040000
Medical Device Problem Code	Circuit Failure (1089)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging during preventive maintenance, an error code related to the oxygen blending module was discovered in the log file.There was no harm or injury reported.The device's oxygen blending module board was replaced to address the issue.Additionally, a generic urgent reminder error code was discovered in the log file.This error code is informational.It is a notification to the user that there is a ventilator service required error active, and no specific replacement parts are required for this error message.

• Brand Name: TRILOGY 202 VENTILATOR, CANADA
• 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: 22885229
• Report Number: 2518422-2025-109338
• Device Sequence Number: 15683084
• Product Code: CBK
• UDI-Device Identifier: 00606959022799
• UDI-Public: (01)00606959022799
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/25/2025

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: CA1040000
• Device Catalogue Number: CA1040000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2025
• Initial Report FDA Received Date: 08/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/21/2020
• 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