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

Model Number	VT2110X24B
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	09/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information that the trilogy evo ventilator was returned to a third-party service center for evaluation of the allegation the left fan being broken.There was no patient involvement and no harm or injury reported.The device error log contained critical ventilator inoperative error codes e-155 and e-156 indicating the machine flow sensor communication ceased and the sensor was stuck at the same value and the therapy central processing unit was still running boot monitor software, respectively.Evaluation completed by the third-party service provider indicated all errors were caused by the system printed circuit board assembly (pca) and the machine flow sensor that had been replaced in the device during the last preventative maintenance.Both components were replaced as part of service and repair.Device evaluation also reported the inlet side panel and cooling fan assembly were damaged and required replacement.The air inlet foam filter required replacement due to preventive maintenance.This device has been serviced, inspected, tested, met acceptance criteria in accordance with all of the applicable customer requirements.

• Brand Name: AERIS EVO
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): RESPIRONICS, INC.; 6501 living place; pittsburgh PA
• Manufacturer (Section G): RESPIRONICS, INC.; 6501 living place; pittsburgh PA
• Manufacturer Contact: melissa rosko ; 1001 murry ridge lane; murrysville, PA ; 7247330200
• MDR Report Key: 23696844
• Report Number: 2518422-2025-112219
• Device Sequence Number: 18422969
• Product Code: CBK
• UDI-Device Identifier: 00606959062962
• UDI-Public: 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/02/2025

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2025
• Initial Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/28/2023
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown