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

Model Number	VT2110X24B
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a pressure sensor mismatch error code occurred after updating an aeris evo/trilogy evo ventilator firmware 1.6.10.00.There was no harm or injury reported.There was no reported patient involvement.It is noted that this was an out of box failure and that sometimes after a few hours of run-in, the error clears, and then sometimes it remains.The internal machine flow sensor needs to be replaced to restore the aeris evo/trilogy evo device to working order per the recommendation of vitalaire italy, medical equipment provider.The device has not been returned to the manufacturer and therefore, unable to confirm the alleged malfunction.At this time a final report will be submitted stating the recommended resolution.If further information becomes available at a later date, a supplemental report will be submitted.No further investigation is required.

• 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: 21964960
• Report Number: 2518422-2025-105218
• Device Sequence Number: 8415213
• 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
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/05/2025

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2024
• Initial Report FDA Received Date: 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/22/2021
• 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