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

Model Number	VT2110X24B
Medical Device Problem Codes	Contamination (1120); Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging maintenance required.There was no serious patient harm or injury that occurred or was reported.During the evaluation of the device at the third-party service center, an error code related to pressure was observed.Evt_press_sensor_mismatch means the device software has detected a large pressure drop between the monitor and outlet pressure sensors (i.E.Across the machine flow sensor).The in-process device evaluation does not identify any specific component malfunction that would need to be replaced to resolve the reported error code, but the machine flow sensor (part# 1135249) has been arranged to be replaced due to being contaminated with dust.Additionally, during the evaluation of the device at the third-party service center, other non-reportable error codes were observed.Evt_voltage_int_li means the internal li-ion battery exceeded the acceptable threshold for a period of time.The system board needs replaced to address the issue.Also, evt_volume_under_delivery is a technical alarm active in the volume modes when the ventilator cannot achieve desired setpoint +/-15% due to the system limitations (e.G current limit, maximum pressure reached, etc.) the replacement of the machine flow sensor should address this issue.

• 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: 24474733
• Report Number: 2518422-2026-007107
• Device Sequence Number: 18537231
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/27/2026

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: VT2110X24B
• Device Catalogue Number: VT2110X24B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/16/2021
• 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