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

Model Number	1040005
Medical Device Problem Codes	Circuit Failure (1089); Failure to Calibrate (2440)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging the differential pressure calibration test step 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 evaluated by the manufacturer service center.During the evaluation it was noted that the nozzle on the sensor board had physical damage that was caused by service.In conclusion, the device's sensor printed circuit assembly (pca) board was replaced to address the issue.The root cause is confirmed at this time.The manufacturer's evaluation is still ongoing due to the device needs to be retested after the parts had been replaced on the device.A follow-up report will be submitted when the manufacturer's investigation is complete.Additionally, during the service of the device, the dc cable was replaced for physical damage unrelated to the reportable issue.
Additional Manufacturer Narrative
The manufacturer received information alleging the differential pressure calibration test step 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 evaluated by the manufacturer service center.During the evaluation it was noted that the nozzle on the sensor board had physical damage that was caused by service.In conclusion, the device's sensor printed circuit assembly (pca) board was replaced to address the issue.The root cause is confirmed at this time.The device was retested, and the differential pressure calibration test step had passed on the device.However, the positive flow test step had failed on the device.The manufacturer's service technician re-evaluated the device and found no problem and they retested the device again.The manufacturer's service technician repeated the test step, and it could not be replicated.However, the check leak and active exhalation verification test steps failed on the device.The manufacturer's service technician re-evaluated the device and found no problem and they retested the device again.The manufacturer's service technician repeated the test step, and it could not be replicated on the device.There were no part(s) and/or repairs made to the device for the following failed test steps for this device: positive flow, check leak, and active exhalation verification.Additionally, during the service of the device, the sd file test steps had failed on the device, and it was due to the test station and/or testing sd cards used to perform the test steps.This was unrelated to the reportable issue.The dc cable was replaced for physical damage unrelated to the reportable issue.The device passed all final testing.

• 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: 23649546
• Report Number: 2518422-2025-112113
• Device Sequence Number: 13268669
• Product Code: CBK
• UDI-Device Identifier: 00606959022737
• UDI-Public: (01)00606959022737
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 01/13/2026

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: 1040005
• Device Catalogue Number: 1040005
• Device Lot Number: 121030
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2012
• 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