MAUDE Adverse Event Report: RESPIRONICS, INC. TRILOGY EV300, USA; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	DS2200X11B
Medical Device Problem Codes	Mechanical Problem (1384); Calibration Problem (2890)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results of the investigation did not uncover any details that would impact the risk analysis for the device.Evaluation: 1.Pil visually inspected the suspect component externally for obvious defects and found none.2.Pil had no original device error log to review.3.Pil performed post test on the pil trilogy evo multifunction test station and the device failed.See attached test results.4.Pil concludes the component does not operate properly due to suspected contamination.Review of the dhr for this device, serial number (b)(6), did not find any non-conformances or abnormalities related to the reportable malfunction identified in this complaint record during testing of the device prior to distribution.
Event or Problem Description
A trilogy ev300 device failed the pressure verification: setpoint 80: pilot: difference diagnostic test.A field service engineer (fse) replaced the solenoid and aecm valves to correct the test failure.The device passed testing.The trilogy evo proportional valve and solenoid valve were returned to the product investigation lab (pil) for additional testing.Pil was able to confirm the failure of the trilogy evo solenoid valve.Visual external inspection found no defects.Pil performed posttest on the pil trilogy evo multifunction test station, and the device failed.Pil concludes that the component does not operate properly due to suspected contamination.Product investigation lab (pil) is unable to confirm the complaint of the trilogy evo proportional valve.Visual inspection found none.Pil performed posttest on the pil trilogy evo multifunction test station and the device passed tests.Pil concludes the component operates properly.

• Brand Name: TRILOGY EV300, USA
• 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: 25587964
• Report Number: 2518422-2026-024988
• Device Sequence Number: 17488189
• Product Code: CBK
• UDI-Device Identifier: 00606959052017
• UDI-Public: (01)00606959052017
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 06/22/2026

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: DS2200X11B
• Device Catalogue Number: DS2200X11B
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 06/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/29/2020
• 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