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

Model Number	ES2110X15B
Medical Device Problem Codes	Mechanical Problem (1384); Failure to Calibrate (2440); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a trilogy evo ventilator failed an active exhalation verification test.There was no serious patient harm or injury that occurred or was reported.The device has not been returned to the manufacturer.At this time, we are unable to confirm the alleged malfunction.A supplemental report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The manufacturer previously received information alleging a trilogy evo ventilator failed an active exhalation verification test.There was no serious patient harm or injury that occurred or was reported.During the evaluation of the device at a third party service center, the failure was not confirmed or reproduced.The service technician notes that the air foam inlet filter, muffler, and particulate filter were replaced for maintenance.The blower, machine flow sensor, and proximal filters were replaced due to dust contamination.The device passed all testing.
Additional Manufacturer Narrative
The manufacturer previously received information alleging a trilogy evo ventilator failed an active exhalation verification test.There was no serious patient harm or injury that occurred or was reported.During the evaluation of the device at a third-party service center, the failure was not confirmed or reproduced.The service technician notes that the air foam inlet filter, muffler, and particulate filter were replaced for maintenance.The blower, machine flow sensor, and proximal filters were replaced due to dust contamination.The device passed all testing.The reported active exhalation verification 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.This report is being submitted to correct the previously reported section h problem code selection of 'no apparent device problem' to 'calibration problem - failure to calibrate' (a0801).

• 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: 24340143
• Report Number: 2518422-2026-005184
• Device Sequence Number: 18591670
• Product Code: CBK
• UDI-Device Identifier: 00606959054080
• UDI-Public: (01)00606959054080
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/29/2026

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: ES2110X15B
• Device Catalogue Number: ES2110X15B
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2026
• Supplement Date Received by Manufacturer: 03/12/2026; Not provided
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 03/16/2026; 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/19/2021
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown