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

Model Number	KR2110X15B
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Mechanical Problem (1384); Device Sensing Problem (2917); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported failure of the machine flow sensor 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 serial number h32945908371e, 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 a ventilator service required alarm had occurred on a trilogy evo device.The device was not in use on a patient at the time of the occurrence.The trilogy evo was returned to the manufacturer 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 on the device's error log.The service technician evaluated and determined that there was contamination found on the machine flow sensor, blower, and inline proximal filter had caused the ventilator service required alarm to occur on the device.In conclusion, the device's machine flow sensor, inline proximal filter, and blower assembly were replaced to address the issue.The root cause is confirmed at this time.Additionally, during the service of the device, the muffler, and air inlet foam filter were replaced for preventative maintenance unrelated to the reportable malfunction/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: 25668838
• Report Number: 2518422-2026-028235
• Device Sequence Number: 10447792
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/30/2026

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: KR2110X15B
• Device Catalogue Number: KR2110X15B
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2026
• Initial Report FDA Received Date: 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2022
• 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