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

Model Number	EU2110X15B
Medical Device Problem Codes	Circuit Failure (1089); Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A trilogy evo was returned to a third-party service center for evaluation.There was no harm or injury reported.The device was not in patient use.During the evaluation a ventilator inoperative alarm was observed in the device's downloaded event log.There was no documentation of any components replaced or resolution for this issue.Additionally, not related to the reportable issue, a service required alarm indicating the detachable battery failed was noted.The detachable battery was replaced to address the issue.Final testing was not documented.A final report is being submitted.If new information becomes available following the completion of the device repair that changes the outcome of the investigation and associated medical device reporting a follow up/supplemental report will be completed.
Additional Manufacturer Narrative
The manufacturer previously reported a trilogy evo was returned to a third-party service center for evaluation.During the evaluation a ventilator inoperative alarm was observed in the device's downloaded event log.There was no documentation of any components replaced or resolution for this issue at the time of the report and final testing was not documented.A service required alarm not related to the reportable issue was documented indicating the detachable battery failed.The detachable battery was replaced to address the issue.Additional information received from the third-party service center confirmed the system board was previously replaced to address the ventilator inoperative alarm condition.Final testing was documented in the notification, and the device passed all final testing.The detachable battery failure issue is not an actionable error and would not affect the device's ability to deliver therapy as designed.The ventilator would continue to operate to design specifications and would operate on its internal battery in the event of a loss of ac power or if the device is disconnected from an ac power source.A corrected report is being submitted to document these findings and the coding has been adjusted to reflect the new information.

• 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: 24719408
• Report Number: 2518422-2026-010126
• Device Sequence Number: 14979804
• Product Code: CBK
• UDI-Device Identifier: 00606959054981
• UDI-Public: (01)00606959054981
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K181166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2026

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: EU2110X15B
• Device Catalogue Number: EU2110X15B
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/07/2021
• 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