MAUDE Adverse Event Report: RESPIRONICS, INC. Trilogy Evo; Ventilator, Continuous, Facility Use

Model Number	ND2110X15B
Medical Device Problem Codes	Circuit Failure (1089); Electrical /Electronic Property Problem (1198); Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information that a trilogy evo ventilator had a red, critical alarm triggered while in use with a patient.There was no harm or injury reported.It was reported the alarm that indicated "ventilator service required" occurred on the device on 11 march 2026.No additional information has been provided at this time.The device has not yet been returned to the manufacturer for evaluation.At this time, the manufacturer is unable to confirm the alleged malfunction.If additional information is received, a follow-up report will be filed.
Additional Manufacturer Narrative
As a result of recently received documentation on 12apr2026 from the sweden competent authority indicates the product problem was documented to have occurred on 23feb2026 as per customer report directly to sweden ca.Notification of the issue was documented in an email to philips eu on 23feb2026, this is a correction notification that the event due date was incorrectly reported on the initial report.

• 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 ; +1(724)733-0200
• MDR Report Key: 24730477
• Report Number: 2518422-2026-010161
• Device Sequence Number: 15770571
• Product Code: CBK
• UDI-Device Identifier: 00606959055513
• UDI-Public: (01)00606959055513
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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,Distributor
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/28/2026

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: ND2110X15B
• Device Catalogue Number: ND2110X15B
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2026
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 04/20/2026; 06/16/2026; 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/12/2019
• 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