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

Model Number	EE2110X15B
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	02/12/2026
Type of Reportable Event	Death
Event or Problem Description
The manufacturer received information alleging a patient death occurred while using a trilogy evo ventilator.A clinical assessment determined: the reported event makes no allegation of any specific device malfunction, use error, failure, labeling, or other deficiency that is relevant to the harm reported.The customer reported that the patient died from an mrsa infection and will be returning the device with its accessories for evaluation.Based on available information at this time, the alleged harm death is assessed as not related to the device in this case.Therefore, based on information available at this time, the device did not cause or contribute to a serious injury or death.Philips is currently investigating this complaint; however, the device examination has not begun because the device has not yet been returned to the manufacturer for investigation.As part of the complaint handling process, the manufacturer will make good faith effort attempts for additional information and to retrieve the device for investigation.If additional information becomes available, a supplemental report will be filed.
Additional Manufacturer Narrative
Previously reported by the manufacturer: the manufacturer received information alleging a patient death occurred while using a trilogy evo ventilator.A clinical assessment determined the reported event makes no allegation of any specific device malfunction, user error, failure, labeling, or other deficiency that is relevant to the harm reported.The customer reported that the patient dies from an mrsa infection and will be returning the device with its accessories for evaluation.Based on information available at this time, the alleged harm death is assessed as not related to the device in this case.Therefore, based on the information available at this time, the device did not cause or contribute to a serious injury or death.New information - the device was returned to a third-party service center for evaluation.During the evaluation, the third-party service center determined (due to health and safety concerns related to the device, the evaluation of the device was not performed.The fields from this evaluation form were filled with na or 0 data, and the device will be shipped to the manufacturer's product investigation lab (pil) for further investigation).If additional information becomes available, a supplemental report will be filed.

• 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: 24344642
• Report Number: 2518422-2026-005203
• Device Sequence Number: 21213215
• Product Code: CBK
• UDI-Device Identifier: 00606959055544
• UDI-Public: (01)00606959055544
• Combination Product (Y/N): N
• Initial Reporter Country: LO
• 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,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2026

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: EE2110X15B
• Device Catalogue Number: EE2110X15B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2026
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 02/16/2026
• Supplement Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/07/2022
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown