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

Model Number	AU2110X15B
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/06/2026
Type of Reportable Event	Death
Event or Problem Description
The manufacturer received information alleging a patient recently deceased and subject to current coroners review.No cause and/or contribution of the device to the patient expiration was alleged and no harm or injury has been reported.Request has been made to send the device to the product investigation lab (pil) for further investigation.Devices is still with the deceased due to a formal coronial investigation.It is anticipated that device will be made available to philips for assessment in the near future.Good faith efforts for additional information are currently in progress.The device has not yet been returned to the manufacturer for evaluation.If any additional information is received, a supplemental report will be filed.
Additional Manufacturer Narrative
The manufacturer previously reported information alleging a patient recently deceased and subject to current coroner's review.No cause and/or contribution of the device to the patient expiration was alleged and no harm or injury has been reported.Request has been made to send the device to the product investigation lab (pil) for further investigation.Devices is still with the deceased due to a formal coronial investigation.It is anticipated that device will be made available to philips for assessment in the near future.The device associated with this complaint was not returned; therefore, a technical evaluation could not be performed, and no further evaluation is possible at this time.A review of the complaint information and relevant production and post-market data determined that there is no new information that changes the device¿s established risk profile.The event does not indicate a systemic issue requiring further corrective or preventive action, and no additional action is warranted at this time.A final report is being submitted.Should the device be returned or additional relevant information become available that impacts the outcome of the investigation or associated medical device reporting, a follow-up or supplemental report will be submitted to the tga in accordance with regulatory requirements.Complaint data for this issue will continue to be monitored and trended as part of the manufacturer¿s post-market surveillance and risk management processes.

• 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: 24007857
• Report Number: 2518422-2026-001216
• Device Sequence Number: 21183741
• Product Code: CBK
• UDI-Device Identifier: 00606959051980
• UDI-Public: (01)00606959051980
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: AU2110X15B
• Device Catalogue Number: AU2110X15B
• 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: 01/06/2026
• Supplement Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 01/08/2026
• Supplement Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/02/2021
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown