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

Model Number	CA1032800B
Medical Device Problem Code	Failure to Calibrate (2440)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A ventilator was returned to the manufacturer for service.There was no serious patient harm or injury that occurred or was reported.The device was not in patient use.During the evaluation of the device at the manufacturer's service center, the device failed the positive flow verification test step during testing.The device was recalibrated to address the issue.
Additional Manufacturer Narrative
The manufacturer previously reported that a ventilator was returned to the manufacturer for service.There was no serious patient harm or injury that occurred or was reported.The device was not in patient use.During the evaluation of the device at the manufacturer's service center, the device failed the positive flow verification test step during testing.The device was recalibrated to address the issue.The device was re-tested and it failed the active exhalation test step.The active exhalation controller valves were replaced to address the issue.Additionally, unrelated to the test failures, damage was found to the universal porting block, the base enclosure and the module plate a.Also, the power cord clamp was found to be missing.The porting block, power cord clamp, base enclosure and module plate a were replaced to address the issues.

• Brand Name: TRILOGY 200
• 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: 23880566
• Report Number: 2518422-2025-113044
• Device Sequence Number: 15854473
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2026

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: CA1032800B
• Device Catalogue Number: CA1032800B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2025
• Supplement Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2016
• 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