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

Model Number	VT2110X24B
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging maintenance required had occurred on a aeris evo device.The device was not in use on a patient at the time of the occurrence.The aeris evo device was returned to the third-party service center for evaluation, and the customer¿s complaint was confirmed.During the evaluation it was noted that an error code, machine flow drift high, was observed on the device's error log.The third-party service technician further evaluated and determined the machine flow sensor had caused the issue to occur on the device.In conclusion, the device's machine flow sensor was replaced to address the issue.The root cause is confirmed at this time.Additionally, during the service of the device, the system printed circuit assembly was replaced to address two non-reportable error codes, drift debug and out pressure railed low, that were observed on the device's error log.This was unrelated to the reportable issue.The machine flow sensor was replaced to address another error code, machine flow drift log, that was observed in the device's error log.This was unrelated to the reportable issue.The air inlet foam filter, particulate filter, and muffler assembly were replaced for preventative maintenance unrelated to the reportable issue.The internal battery door was replaced for physical damage unrelated to the reportable issue.The blower, blower bellows seal, blower mount, and two in-line proximal filters were replaced for contamination unrelated to the reportable issue.The device passed all final testing.

• 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: 24903997
• Report Number: 2518422-2026-010940
• Device Sequence Number: 9827410
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/16/2026

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
• Operator of Device: Other
• 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: 04/02/2026
• Initial Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/29/2021
• 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