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

Model Number	IN2110X15B
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information received from the device evaluation indicating an additional critical ventilator service required alarm had occurred and was documented in the device error log indicating the device software has detected a large pressure drop between the monitor and outlet pressure sensors (i.E.Across the machine flow sensor).
Additional Manufacturer Narrative
The device mentioned in this complaint has exceeded its useful life per the applicable ifu.Therefore, the dhr for this device will not be reviewed at this time.However, the dhr files for this device are available and can be accessed upon specific request.The reported failure of the trilogy evo 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.
Event or Problem Description
The manufacturer received information that a trilogy evo ventilator was returned to a third-party service center for completion of preventative maintenance.There was no patient involvement, and no harm or injury reported.On evaluation, a critical device error code e-386 was noted in the error log indicating machine flow sensor offset greater than 0.2 slpm.The machine flow sensor required replacement to address this issue.Additional findings not related to the malfunction/issue: the system printed circuit board assembly required replacement and interior components were noted to be contaminated with dust including the machine flow sensor.Preventative maintenance with required component replacements required.

• 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: 25549574
• Report Number: 2518422-2026-023686
• Device Sequence Number: 14865211
• Product Code: CBK
• UDI-Device Identifier: 00606959051959
• UDI-Public: (01)00606959051959
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2026

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?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/18/2026
• Supplement Report FDA Received Date: 06/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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