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

Model Number	AU2110X15B
Medical Device Problem Codes	Circuit Failure (1089); Electrical /Electronic Property Problem (1198); Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received a report that a trilogy evo ventilator was returned for service.No patient injury or serious harm was reported.The device was returned to a third-party service center for evaluation.The device log files were successfully downloaded and reviewed in full.Analysis of the logs identified a "vent service required" alarm indicating that the internal or detachable li-ion battery was not charging due to a hardware fault for a duration of one minute or more.To resolve this issue, the system printed circuit assembly (pca) and battery were replaced.Additionally, the battery muffler was replaced due to dust, and the filter was replaced due to contamination.The device filters and filter cap were also replaced.A final report is being submitted.If any additional information is received, a supplemental report will be filed.
Additional Manufacturer Narrative
The reported failure of a vent service required alarm indicating that the internal or detachable li-ion battery was not charging due to a hardware fault for a duration of one minute or more is accommodated in the product risk management file as being linked to hazard with description loss of function/loss of primary function.Complaints for this failure are reviewed via the post market complaint trending and escalation processes to assess for the observed probability levels and compare them with the predicted levels in the risk file for the hazards linked to the failure.As of the date of submission for this report, there is no indication that complaints for the failure in question has led to unacceptable increase in probability levels for the hazardous situations in scope, and therefore no further action will be pursued.Qa continues to monitor complaints for this issue per the cadence in the complaint trending procedures.

• 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: 25081284
• Report Number: 2518422-2026-011541
• Device Sequence Number: 10418374
• 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
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/05/2026

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: AU2110X15B
• Device Catalogue Number: AU2110X15B
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/15/2022
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown