MAUDE Adverse Event Report: Respironics, Inc. Trilogy Evo, Korea; Ventilator, Continuous, Facility Use

Model Number	KR2110X15B
Medical Device Problem Codes	Failure to Calibrate (2440); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a ventilator required service.There was no harm or injury reported.The device was not in patient use.During the evaluation of the device at the manufacturer's service center, review of the ventilator logs found error code 384- evt_press_sensor_mismatch, indicating that the device software has detected a large pressure drop between the monitor and outlet pressure sensors.The device's two in-line filter, prox and fio2 tubbing were found to be contaminated with dust and were replaced to address the issues.In addition, internal corrosion and contamination were also identified on the blower, requiring replacement of the blower assembly.As part of the required four-year preventive maintenance assessment, the inlet foam filter and muffler assembly were replaced.Following completion of the required service activities, the device passed final functional testing.
Additional Manufacturer Narrative
The reported failure of error code 384- evt_press_sensor_mismatch, 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 sn: (b)(6).Review confirms that the device met the final acceptance criteria and was released for final distribution.

• Brand Name: Trilogy Evo, Korea
• 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 ; +1(724)733-0200
• MDR Report Key: 50883941
• Report Number: 2518422-2026-046360
• Device Sequence Number: 21512284
• Product Code: CBK
• UDI-Device Identifier: 00606959055483
• UDI-Public: (01)00606959055483
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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: KR2110X15B
• Device Catalogue Number: KR2110X15B
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2021
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown