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

Model Number	CA1032800
Medical Device Problem Code	Failure to Calibrate (2440)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging that the active exhalation purge, active proport valve, and check leak test steps had failed on a trilogy 200 device.The device was not in use on a patient at the time of the occurrence.The trilogy 200 device was being evaluated at the third-party service center when these test steps had failed on the device.During the evaluation it was noted that a misassemble in the transition tube of the blower assembly had cause the active exhalation purge, active proport valve, and check leak test steps to fail on the device.In conclusion, the device's transition tube was properly reassembled to address the issue.The root cause is confirmed at this time.Additionally, during the service of the device, the front enclosure and handle assembly were replaced for physical damage unrelated to the reportable issue.The humidifier feet and power cord clamp were replaced since these parts were missing on the device.This was unrelated to the reportable issue.

• 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: 25104659
• Report Number: 2518422-2026-011921
• Device Sequence Number: 18828791
• 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): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/06/2026

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: CA1032800
• Device Catalogue Number: CA1032800
• Device Lot Number: 111003
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/10/2011
• 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