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

Model Number	IN2110X15B
Medical Device Problem Codes	Circuit Failure (1089); Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported failure of both the outlet and monitor pressure sensor failed is accommodated in the product risk management file as being linked to hazard with description loss of function/loss of primary 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, h376184514be9 review confirms that the device met the final acceptance criteria and was released for final distribution.
Event or Problem Description
The manufacturer received information alleging that a trilogy evo international ventilator was inoperative and displayed an error code.There was no report of patient harm or injury.The device was not in use on a patient at the time of the event.The device was evaluated at a third-party service center.Review of the device event log identified a ventilator inoperative condition associated with error code evt_press_sensors_failure, indicating failure of both the outlet pressure sensor and monitor pressure sensor.Service personnel replaced the system printed circuit assembly (pca), after which the device returned to normal operation.

• Brand Name: TRILOGY EVO, INTERNATIONAL
• 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: 25364641
• Report Number: 2518422-2026-018355
• Device Sequence Number: 21486058
• Product Code: CBK
• UDI-Device Identifier: 00606959051959
• UDI-Public: (01)00606959051959
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: Other,Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/02/2026

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2026
• Initial Report FDA Received Date: 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/10/2025
• 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