MAUDE Adverse Event Report: RESPIRONICS, INC. TRILOGY 200 VENTILATOR, CANADA - BT; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	CA1032800B
Medical Device Problem Codes	Circuit Failure (1089); Failure to Calibrate (2440)
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
A trilogy 200 ventilator, canada - bt was returned to the manufacturer for routine preventative maintenance.There was no allegation of patient harm.The device was not reported to be in patient use.The trilogy 200 ventilator, canada - bt device failed a dp purge valves test step during evaluation at the manufacturer's service center.The technician recommended replacing the device's sensor board to address the issue.The repair evaluation is awaiting customer approval.A final report is being submitted.If new information becomes available following the completion of the device repair that changes the outcome of the investigation and associated medical device reporting a follow up/supplemental report will be completed.

• Brand Name: TRILOGY 200 VENTILATOR, CANADA - BT
• 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: 23871872
• Report Number: 2518422-2025-112979
• Device Sequence Number: 4552727
• Product Code: CBK
• UDI-Device Identifier: 00606959026452
• UDI-Public: (01)00606959026452
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K093416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/22/2025

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: CA1032800B
• Device Catalogue Number: CA1032800B
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/10/2017
• 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