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

Model Number	FX2100X15B
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported active exhalation control module valves failure 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.Dhr review was performed for the complaint device serial number, (b)(6) review confirms that the device met the final acceptance criteria and was released for final distribution.
Event or Problem Description
The manufacturer received information on a trilogy evo alleging alarm: maintenance required.There was no serious patient harm or injury that occurred or was reported.The device was not in patient use.During the evaluation of the device by the distributor, an error code, evt_aecm_failure, related to the active exhalation control module valves was observed.The device will still provide therapy but cannot control the diaphragm in the circuit.The device's three-way solenoid valve and proportional valve were replaced to address the issue.

• 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: 25284321
• Report Number: 2518422-2026-016565
• Device Sequence Number: 13283266
• Product Code: CBK
• UDI-Device Identifier: 00606959061019
• UDI-Public: (01)00606959061019
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/26/2026

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: FX2100X15B
• Device Catalogue Number: FX2100X15B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/18/2020
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown