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

Model Number	1040005B
Medical Device Problem Codes	Failure to Calibrate (2440); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information from a philips service technician that the positive flow verify test steps had failed on the trilogy 200 device.There was no serious patient harm or injury that occurred or was reported.Philips is currently investigating this complaint.The device has been received by the (third-party service center/manufacturer) and is currently awaiting evaluation.A supplemental report will be submitted as due.
Additional Manufacturer Narrative
The manufacturer received information from a philips service technician that the positive flow verify test steps had failed on the trilogy 200 device.There was no serious patient harm or injury that occurred or was reported.The trilogy 200 device was evaluated at the manufacturer service center for this issue.During the evaluation it was noted that the devices calibration was incorrect on the device causing the positive flow verify test steps to fail on the device.The manufacturer service technician recalibrated the device to address the issue.The manufacturer service technician re-performed the test steps, and the positive flow verification test step passed on the device.However, the active exhalation proportional valve and low flow o2 test steps had failed on the device.The device was re-evaluated by the manufacturer's service technician.The manufacturer's service technician re-evaluated and determined the active exhalation control module (or active exhalation controller) was replaced to address this issue.Additionally, during the service of the device, the cord retainer, rubber feet, and base enclosure assembly were replaced for physical damage unrelated to the reported issue.

• 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: 23535943
• Report Number: 2518422-2025-111764
• Device Sequence Number: 10167753
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2026

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 01/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2014
• 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