MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION VOLARA SYSTEM; DEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT

Model Number	M08594
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Respiratory Tract Infection (2420)
Date of Event	09/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient developed pseudomonas attributed to a volara system.The patient stated they couldn¿t get the water out of the tubing, and this was the cause of the patient¿s pseudomonas infection.The patient was hospitalized for three days.Treatment of the infection was not reported.The patient has not restarted the volara system until they see their new pulmonologist in approximately six weeks.No further information was provided.
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional information was added to h6.H11: a device history review revealed no issues that could have caused or contributed to the reported issue.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: VOLARA SYSTEM
• Common Device Name: DEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): HILL-ROM SINGAPORE; 1 yishun avenue 7; singapore, north east 76892 3; SN 768923
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 23408515
• Report Number: 3008145987-2025-00017
• Device Sequence Number: 8791382
• Product Code: NHJ
• UDI-Device Identifier: 00887761984578
• UDI-Public: (01)00887761984578(11)231117
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: M08594
• Device Catalogue Number: M08594
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2025
• Supplement Date Received by Manufacturer: 12/02/2025
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/17/2023
• 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 Age: 67 YR
• Patient Sex: Female