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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2025
Type of Reportable Event	Death
Event or Problem Description
The manufacturer received information that a loaner trilogy evo ventilator was returned to the manufacturer due to a patient passing away.It was noted that the patient was not on the device at the time of death and there is no allegation that the device contributed to the death.The device was evaluated by the manufacturer and no actionable error codes or malfunctions were observed.The unit was calibrated and confirmed to be working correctly.Operation hrs = 0.8 / blower hrs = 0.8.In addition, the technician replaced the air inlet filter & particulate filter.The unit was decontaminated before returning to the enable room.The software version 1.06.10.00.Philips was notified that the patient passed away on 21/5.The device arrived in nr on 23/5 without the power cord or bag.Healthshare to be informed that these accessories will need to be replaced.This event was reviewed by the manufacturer clinical assessment team and was 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.Additionally, there is no other clinical information provided to indicate any causal relationship between the device and the reported death.Based on available information, the reported 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.No further action is required.Although there is not an allegation that the device caused or contributed to the mentioned "death" a report will be filed with all applicable regulatory agencies.An attempt to gather additional information on the cause of death is being requested.If additional information is provided a supplemental report will be filed with all applicable regulatory agencies.

• 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: 22353129
• Report Number: 2518422-2025-106917
• Device Sequence Number: 8082043
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/28/2025

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2023
• 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