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

Model Number	TR2110X15B
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported failure of the trilogy 100 ventilator machine flow sensor and sensor printed circuit board is accommodated in the product risk management file as being linked to hazard with description patient exposure to function / deterioration of function.Complaints for this failure are reviewed via the post market complaint trending and escalation processes to assess for the observed probability levels and compare them with the predicted levels in the risk file for the hazards linked to the failure.As of the date of submission for this report, there is no indication that complaints for the failure in question has led to unacceptable increase in probability levels for the hazardous situations in scope, and therefore no further action will be pursued.Qa continues to monitor complaints for this issue per the cadence in the complaint trending procedures.Review of the dhr for this device, serial number (b)(6), did not find any non-conformances or abnormalities related to the reportable malfunction/ allegation identified in this complaint record during testing of the device prior to distribution.
Event or Problem Description
The manufacturer received information alleging a patient experienced an interruption in therapy while using a trilogy evo device as it was reported to stop operating.The patient experienced a temporary interruption in therapy, and a backup device was required to continue treatment.No patient harm or injury were reported.The trilogy evo device was evaluated at the customer site.During the evaluation, it was noted that there was a significant amount of dust that had accumulated in the machine flow sensor.It was also determined that the particulate filter, which should be included in the device package, was not provided with the device.The home healthcare provider assumed that the filter was not required for home use and continued to use the device without it.As a result, environmental dust accumulated in the machine flow sensor over time, causing failed operation of the sensor.The machine flow sensor was replaced to address the issue.The device was tested and proper operation was confirmed.

• Brand Name: TRILOGY EVO
• 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: 25640828
• Report Number: 2518422-2026-026936
• Device Sequence Number: 9344067
• Product Code: CBK
• UDI-Device Identifier: 00606959055551
• UDI-Public: (01)00606959055551
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K181166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/26/2026

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: TR2110X15B
• Device Catalogue Number: TR2110X15B
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2026
• Initial Report FDA Received Date: 06/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2023
• 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