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

Model Number	CA1032800
Medical Device Problem Codes	Circuit Failure (1089); Electrical /Electronic Property Problem (1198); Mechanical Problem (1384); Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A ventilator was returned to a third-party service center for service.There was no serious patient harm or injury reported.The device was not reported to be in clinical use.During the evaluation of the device at a third-party service center, a ventilator inoperative error was confirmed in the event log.The device's blower needs to be replaced to address the issue.
Additional Manufacturer Narrative
The manufacturer previously reported a trilogy 200 alarmed for a ventilator inoperative alarm condition indicating a motor failure.The device's blower was replaced to address the issue.During final testing the device failed to power on.The system board was found to be corrupted and was replaced to address the issue.The device was tested and passed final testing.

• Brand Name: TRILOGY
• 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: 24080827
• Report Number: 2518422-2026-002465
• Device Sequence Number: 5879009
• Product Code: CBK
• UDI-Device Identifier: 00606959022782
• UDI-Public: (01)00606959022782
• 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: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2026

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
• Device Model Number: CA1032800
• Device Catalogue Number: CA1032800
• Device Lot Number: 120201
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2025
• Supplement Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 01/15/2026
• Supplement Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/13/2012
• 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