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

Model Number	VT2110X24B
Medical Device Problem Codes	Circuit Failure (1089); Mechanical Problem (1384); Failure to Calibrate (2440)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The aeris evo ventilator was returned to a third-party service center for evaluation, and the customer¿s complaint was confirmed.The device was not in use on a patient at the time of the occurrence.During the evaluation of the device an error code indicating (aev_failure) was recorded in the device event log.In conclusion, the device's trilogy evo 3 way solenoid valve and proportional valve (aecm) needs to be replaced to address the issue.Additionally, during the service of the device, an error code in relation to outlet pressure sensor railed to maximum negative value was recorded in the event log unrelated to the reportable malfunction/issue.The technician recommends replacing the system board to address the issue.The inlet foam filter muffler and particulate filter was replaced as a part of required preventative maintenance.The internal battery door is damaged and needs to be replaced.The blower, blower chassis plate, bellow, machine flow sensor, proximal filters, in-line filter and system board tubing need to be replaced due to contamination.The evaluation is currently in process, and repairs have not yet begun.If additional information becomes available a supplemental report will be filed.
Additional Manufacturer Narrative
Previously reported by the manufacturer: the aeris evo ventilator was returned to a third-party service center for evaluation, and the customer¿s complaint was confirmed.The device was not in use on a patient at the time of the occurrence.During the evaluation of the device an error code indicating (aev_failure) was recorded in the device event log.In conclusion, the device's trilogy evo 3 way solenoid valve and proportional valve (aecm) needs to be replaced to address the issue.Additionally, during the service of the device, an error code in relation to outlet pressure sensor railed to maximum negative value was recorded in the event log unrelated to the reportable malfunction/issue.The technician recommends replacing the system board to address the issue.The inlet foam filter muffler and particulate filter was replaced as a part of required preventative maintenance.The internal battery door is damaged and needs to be replaced.The blower, blower chassis plate, bellow, machine flow sensor, proximal filters, in-line filter and system board tubing need to be replaced due to contamination.The evaluation is currently in process, and repairs have not yet begun.If additional information becomes available a supplemental report will be filed.New information: new information: the aeris evo ventilator evaluation was concluded and error codes in relation to (ev_failure) (press_sensor_mismatch) and (out_press_railed_low) were noted in the device event log.The 3-way solenoid valves and aecm valve were recommended to be replaced to address the issue of ev_failure.The system board is defective and was recommended to be replaced to address the issue of out_press_railed_low.The device will be scrapped as per customer request.Correction to the previously filed conclusion code in box h.

• 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: 23801101
• Report Number: 2518422-2025-112641
• Device Sequence Number: 9360426
• 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): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2025

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
• Operator of Device: Other
• Device Model Number: VT2110X24B
• Device Catalogue Number: VT2110X24B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2025
• Supplement Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/22/2021
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown