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

Model Number	DS2200X11B
Medical Device Problem Codes	Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a failed test step occurred on a trilogy ev300 ventilator.The device was not reported to be in use on a patient at the time of the occurrence.The trilogy ev300 ventilator was evaluated by a third-party service center field service engineer, and the customer¿s complaint was confirmed.During the evaluation it was noted that the device failed a pre-test.In conclusion, the device's trilogy evo 3 way solenoid valve and proportional valve (aecm) needs to be replaced to address the issue.The repairs have not begun, and the completion of the evaluation is pending.If additional information becomes available, a supplemental report will be filed.

• 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: 25609026
• Report Number: 2518422-2026-025471
• Device Sequence Number: 15938244
• Product Code: CBK
• UDI-Device Identifier: 00606959052017
• UDI-Public: (01)00606959052017
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2026

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: DS2200X11B
• Device Catalogue Number: DS2200X11B
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2026
• Supplement Date Received by Manufacturer: 06/24/2026
• Initial Report FDA Received Date: 06/24/2026
• Supplement Report FDA Received Date: 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2020
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown