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

Model Number	IN2110X15B
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Audible Prompt/Feedback Problem (4020)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging the alarms on a trilogy evo mechanical ventilator failed to activate while the device was connected to a patient during clinical use.The customer requested technical inspection of the device.The patient reportedly expired; however, the cause of death was unknown at the time of reporting, and no information was provided to establish that the device caused or contributed to the reported death.No additional patient impact or intervention information was provided.Additional information received indicated that, after gathering and reviewing all relevant available information, the customer determined the event was not caused by equipment failure.The customer requested confirmation on whether factory evaluation of the device was still required or whether the case could be closed based on the available information.A request was made for the device to be returned for evaluation.Philips has requested additional information regarding the reported event and device performance.If new relevant information becomes available, a supplemental report will be submitted accordingly.

• 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: 25239748
• Report Number: 2518422-2026-015397
• Device Sequence Number: 13152403
• Product Code: CBK
• UDI-Device Identifier: 00606959051959
• UDI-Public: (01)00606959051959
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2026

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?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2026
• Supplement Date Received by Manufacturer: 06/12/2026
• Initial Report FDA Received Date: 05/21/2026
• Supplement Report FDA Received Date: 06/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/23/2021
• 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