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

Model Number	BL2110X15B
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Battery Problem (2885); Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information that a trilogy evo ventilator was returned to a third-party service center for evaluation.There was no patient involvement, and no harm or injury reported.It was reported the device experienced error codes e-206, e-207, and e-325.These error codes indicate both soft power fail and hard power fail; the device turns off and associated audio and visual alarms occurred associated with battery depletion.Although there was no patient harm or injury, this event is reportable because the failure could affect the ability of the device to provide therapy to published specifications.The device has not yet been returned to the manufacturer for evaluation; therefore, the alleged malfunction is not able to be confirmed at this time.A follow-up report will be submitted when the manufacturer's investigation has been completed.
Additional Manufacturer Narrative
It was previously reported on the initial report: the manufacturer received information that a trilogy evo ventilator was returned to a third-party service center for evaluation.There was no patient involvement, and no harm or injury reported.Correction to b5: the manufacturer received information that critical error codes were present in the device error log.There was no patient involvement, and no harm or injury reported.
Additional Manufacturer Narrative
The manufacturer received information that a trilogy evo ventilator was evaluated was returned to a third-party service center for completion of required maintenance and evaluation of customer-reported device error codes.There was no patient involvement, and no harm or injury reported.On device evaluation, critical device error code e-325 was confirmed present in the device error log indicating the power vbus dropped.This issue was not reproduced on device testing during the device evaluation.No components were replaced in the device associated with the recorded error code.The scheduled 4-year device maintenance was completed.Additional findings not related to the malfunction/issue: the proximal filter was replaced due to dust contamination.This device has been serviced, inspected, tested, met acceptance criteria in accordance with all of the applicable customer requirements.

• 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: 24335445
• Report Number: 2518422-2026-005102
• Device Sequence Number: 13200146
• Product Code: CBK
• UDI-Device Identifier: 00606959055520
• UDI-Public: (01)00606959055520
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/17/2026

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: BL2110X15B
• Device Catalogue Number: BL2110X15B
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2026
• Supplement Date Received by Manufacturer: 02/09/2026; 03/10/2026
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 02/24/2026; 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/27/2021
• 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