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

Model Number	VT2110X24B
Medical Device Problem Codes	Contamination (1120); Decrease in Pressure (1490)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging the inspiratory phase is not working on a aeris evo.The device was not reported to be in use on a patient at the time of the occurrence.The aeris evo was returned to the third-party service center for evaluation.During the evaluation it was noted that an error code indicting the device software has detected a large pressure drop between the monitor and outlet pressure sensors was recorded in the device event log caused by contamination in the blower, machine flow sensor and in-line filter and proximal filter.Additionally, due to preventive maintenance, the muffler assembly, particulate filter, air inlet foam filter need to be replaced, unrelated to the reportable malfunction.The evaluation of the device is still in process.If any additional information is received, a follow-up report will be filed.
Additional Manufacturer Narrative
Previously reported by the manufacturer: the manufacturer received information alleging the inspiratory phase is not working on a aeris evo.The device was not reported to be in use on a patient at the time of the occurrence.The aeris evo was returned to the third-party service center for evaluation.During the evaluation it was noted that an error code indicting the device software has detected a large pressure drop between the monitor and outlet pressure sensors was recorded in the device event log caused by contamination in the blower, machine flow sensor and in-line filter and proximal filter.Additionally, due to preventive maintenance, the muffler assembly, particulate filter, air inlet foam filter need to be replaced, unrelated to the reportable malfunction.The evaluation of the device is still in process.If any additional information is received, a follow-up report will be filed.New information: the evaluation was concluded and the customer complaint of "inspiratory phase not working" was not confirmed.The blower, machine flow sensor, in-line filter and proximal filter have to be replaced due to contamination to address the issue of "large pressure drop between the monitor and outlet pressure sensor".The device passed all testing.This device has been serviced, inspected, tested, met acceptance criteria in accordance with all of the applicable customer requirements as defined in the contractual agreement with plexus.The device history record has been reviewed and approved by plexus quality assurance.

• 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: 23716622
• Report Number: 2518422-2025-112296
• Device Sequence Number: 10244919
• 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): 12/16/2025

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2025
• Supplement Date Received by Manufacturer: 12/06/2025
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 12/16/2025
• 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