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

Model Number	IN2110X15B
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported failure of ventilator service required alarm associated with the device software detecting a large pressure drop between the monitor and outlet pressure sensors 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.
Event or Problem Description
The manufacturer received a customer report indicating that a "ventilator service required" alarm occurred on a trilogy evo ventilator.The device was replaced.There was no serious patient harm or injury that occurred or was reported.The ventilator was returned to the manufacturer for evaluation.During testing, the reported issue was not reproduced; however, review of the device log files confirmed the occurrence of a "ventilator service required" alarm.The logs indicated that the device software detected a large pressure drop between the monitor and outlet pressure sensors.Internal inspection identified contamination of the flow sensor.As part of service and refurbishment, multiple components were replaced, including the system printed circuit assembly (pca), blower assembly, flow sensor, 3-way solenoid valve, proportional valve, low flow o2 tubing, blower chassis plate, blower cap, outlet side panel, blower mount, blower bellow seal, fio2 housing, dual limb cup, filter cover, muffler assembly, tubing-blower chassis, tubing fio2, low flow o2 connector, tubing-system pca.During functional testing of the device, the unit failed the fio2 sensor receptacle verification: energized: proximal pressure test.This test verifies that the fio2 solenoid is able to open and the tubing that is connected to the fio2 sensor receptacle is not kinked or occluded.If the tubing was kinked, occluded, or the solenoid valve did not open, there would be no circulation of air and oxygen to pass across the fio2 sensor.The fio2 sensor is used for monitoring purposes only and does not affect therapy.The inline proximal filter was replaced, and additional preventive maintenance was performed, including replacement of the air inlet foam filter and particulate filter.The manufacturer¿s service technician completed final and run-in testing, including battery and valve checks, and performed cleaning.The device was confirmed to be operating properly.

• 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: 24884322
• Report Number: 2518422-2026-010894
• Device Sequence Number: 13402968
• Product Code: CBK
• UDI-Device Identifier: 00606959051959
• UDI-Public: (01)00606959051959
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K181166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/15/2026

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: IN2110X15B
• Device Catalogue Number: IN2110X15B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2020
• 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