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

Model Number	1040005B
Medical Device Problem Codes	Circuit Failure (1089); Electrical /Electronic Property Problem (1198); Failure to Calibrate (2440)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a trilogy 200 ventilator did not meet acceptance criteria of evaluation process.The device was not in use on a patient at the time of the occurrence.The trilogy 200 ventilator was returned to the manufacturer service center for evaluation.During the evaluation it was noted that the device failed a test step during testing and was returned to the technician for further evaluation.There were no significant event(s) in the error log(s).The root cause isn't confirmed at this time.Additionally, during the service of the device, the technician confirmed the device mac address label was added - original was illegible, universal porting block port, rear and front enclosure was damaged, and all were replaced unrelated to the reportable malfunction/issue.If any additional information is received, a follow-up report will be filed.
Additional Manufacturer Narrative
Previously reported by the manufacturer: the manufacturer received information alleging a trilogy 200 ventilator did not meet acceptance criteria of evaluation process.The device was not in use on a patient at the time of the occurrence.The trilogy 200 ventilator was returned to the manufacturer service center for evaluation.During the evaluation it was noted that the device failed a test step during testing and was returned to the technician for further evaluation.There were no significant event(s) in the error log(s).The root cause isn't confirmed at this time.Additionally, during the service of the device, the technician confirmed the device mac address label was added - original was illegible, universal porting block port, rear and front enclosure was damaged, and all were replaced unrelated to the reportable malfunction/issue.If any additional information is received, a follow-up report will be filed.New information: during the evaluation the device failed a test step for (dp purge valves and dp calibration: dp @ 10.00 cmh2o).Inconclusion the sensor board was replaced, and the device was recalibrated to address the issues.Device passed all testing.Additionally, the device failed a test step for check clock settings therefore the real time clock was reset to address the issue unrelated to the reported malfunction.Box h coding was updated.

• 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: 23426539
• Report Number: 2518422-2025-111455
• Device Sequence Number: 9863591
• Product Code: CBK
• UDI-Device Identifier: 00606959026445
• UDI-Public: (01)00606959026445
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2026

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: 1040005B
• Device Catalogue Number: 1040005B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2025
• Supplement Date Received by Manufacturer: 12/31/2025
• Initial Report FDA Received Date: 10/30/2025
• Supplement Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2014
• 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