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

Model Number	CA1032800
Medical Device Problem Codes	Circuit Failure (1089); Mechanical Problem (1384); Failure to Calibrate (2440)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2026
Type of Reportable Event	Malfunction
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.During the evaluation of the device at the manufacturer's service center, the device failed the active exhalation proportional valve test step during testing.The device's system/cpu board needs replaced to address the issue.Additionally, unrelated to the test failure, during the evaluation of the device at the manufacturer's service center, the device was found to have missing/displaced rubber feet, the porting block port was found to be pinched/damaged, the cord retainer was found to be missing/broken and the handle was found to be cracked.Enclosure feet, the universal porting block, the cable clamp and handle need to be replaced to address the issues.After the device's system/cpu board was replaced, the device was re-tested and the device failed the active exhalation proportional valve test step during testing.Upon investigation, found the tubing was damaged.The device's tubing was replaced to address the issue.Additionally, necessary service of the device was performed at the manufacturer's service center, but the device was returned to technician for additional evaluation due to failed low flow o2 repair test.Upon inspection for o2 failure, it was discovered that the grey removable foam was not correctly installed.Reinstalled foam correctly and device retested.Device passed all testing.
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.During the evaluation of the device at the manufacturer's service center, the device failed the active exhalation proportional valve test step during testing.The device's system/cpu board needs replaced to address the issue.Additionally, unrelated to the test failure, during the evaluation of the device at the manufacturer's service center, the device was found to have missing/displaced rubber feet, the porting block port was found to be pinched/damaged, the cord retainer was found to be missing/broken and the handle was found to be cracked.Enclosure feet, the universal porting block, the cable clamp and handle need to be replaced to address the issues.

• Brand Name: TRILOGY 200 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: 24305971
• Report Number: 2518422-2026-004596
• Device Sequence Number: 20119488
• 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: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2026

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2026
• Supplement Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2011
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown