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

Model Number	DE2110X13B
Medical Device Problem Code	Failure to Calibrate (2440)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging the active exhalation verification and motor calibration verification: reset motor calibration test steps had failed on a trilogy evo device.The device was not in use on a patient at the time of the occurrence.The trilogy evo device was returned to the third-party service center for evaluation.During the evaluation it was noted that the device's blower cable was not properly connected causing a proper connection to the system printed circuit assembly (pca) board and machine flow sensor had failed.The third-party service technician confirmed that it was the replaced machine flow sensor that failed for these test steps; not the one that had contamination on it.In conclusion, the device's blower cable was re-connected to the system pca board, and the machine flow sensor was replaced to address the issues.The root cause is confirmed at this time.Additionally, during the service of the device, contamination found on the blower assembly, machine flow sensor, and in-line filter proximal which were unrelated to the reportable malfunction/issue.The following parts were replaced as part of the four-year preventative maintenance on this device: muffler assembly, air foam inlet filter, and particulate filter.

• 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: 23096833
• Report Number: 2518422-2025-110388
• Device Sequence Number: 9226304
• Product Code: CBK
• UDI-Device Identifier: 00606959054110
• UDI-Public: (01)00606959054110
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K181166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/19/2025

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: DE2110X13B
• Device Catalogue Number: DE2110X13B
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2025
• Initial Report FDA Received Date: 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/23/2021
• 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