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

Model Number	VT2110X24B
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2024
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 of the reported maintenance requested alarm that occurred after a software update.There no harm or injury reported.On device evaluation, error codes e-200 and e-201 indicate therapy buzzer failure and power buzzer failure, respectively.The buzzer requires replacement to address this issue.As part of preventative maintenance, the air foam inlet filter requires replacement.The device passed all testing.This device has been serviced, inspected, tested, met acceptance criteria in accordance with all of the applicable customer requirements.
Additional Manufacturer Narrative
It was previously reported: the manufacturer received information that a trilogy evo ventilator was returned to a third-party service center for evaluation of the reported maintenance requested alarm that occurred after a software update.There is no harm or injury reported.On device evaluation, error codes e-200 and e-201 indicate therapy buzzer failure and power buzzer failure, respectively.The buzzer requires replacement to address this issue.An additional review of the complaint information indicates this issue was reported in error.The reported issue would only be a reportable device issue per reporting guidelines if the error codes reported were also accompanied by an additional microphone error, which did not occur on this device.Therefore, this device issue does not meet the criteria of a reportable device malfunction per trilogy evo reportability guidelines.The coding grid has been updated accordingly as applicable.

• Brand Name: AERIS 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: 23615603
• Report Number: 2518422-2025-111974
• Device Sequence Number: 9051921
• Product Code: CBK
• UDI-Device Identifier: 00606959062962
• UDI-Public: (01)00606959062962
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2025

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: VT2110X24B
• Device Catalogue Number: VT2110X24B
• 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: 12/16/2024
• Supplement Date Received by Manufacturer: 01/16/2025
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/22/2021
• 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