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

Model Number	EE2110X15B
Medical Device Problem Codes	Contamination (1120); Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a patient experienced a ventilator service required while using the trilogy evo device.There was no allegation of serious or permanent harm or injury.No medical intervention was specified by the patient.The trilogy evo was returned to the third-party service center for evaluation, and the customer¿s complaint was confirmed.During the evaluation it was noted that an error code, pressure sensor mismatch, was observed in the device's error log.The third-party service technician further evaluated and found contamination on the machine flow sensor, in-line filter proximal and low-flow o2 tubing that had caused the reportable issue to occur on the device.In conclusion, the device's machine flow sensor, in-line filter proximal and low-flow o2 tubing were replaced to address the issue.The root cause is confirmed at this time.Additionally, during the service of the device, the blower assembly was replaced for another error code, inlet filter block, that was observed on the device's error log.This was unrelated to the reportable issue.The system printed circuit assembly was replaced for another error code, motor flux magnitude runtime, that was observed on the device's error log.This was unrelated to the reportable issue.The three-way solenoid valve needs replaced for damage unrelated to the reportable issue.The air inlet foam filter and particulate filter were replaced for preventative maintenance unrelated to the reportable issue.The device passed all final testing.

• 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: 24617456
• Report Number: 2518422-2026-009666
• Device Sequence Number: 15987016
• Product Code: CBK
• UDI-Device Identifier: 00606959055544
• UDI-Public: (01)00606959055544
• Combination Product (Y/N): N
• Initial Reporter Country: RO
• 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: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/17/2026

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: EE2110X15B
• Device Catalogue Number: EE2110X15B
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/02/2023
• 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