MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION Volara System; DEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT

Model Number	M08594
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that following volara device training on (b)(6) 2025, the patient experienced a leaking nebulizer cup and discontinued use of the device due to medication leakage and lack of perceived therapeutic benefit.The patient, an 81-year-old female with a history of bronchiectasis, reported three bronchiectasis exacerbations that temporally coincided with device use; however, specific dates could not be recalled.The reported exacerbations were treated with levaquin, azithromycin, and amoxicillin.The patient was uncertain whether a circuit-related issue contributed to the events.The exact cause of the exacerbations remains unknown; however, device contribution cannot be excluded.The patient requested in-home retraining and a circuit exchange.A replacement circuit and return packaging were provided, and the device remains with the patient pending re-education and resumption of therapy.No further information was available at the time of this report.
Additional Manufacturer Narrative
The investigation is ongoing, however if any additional relevant information is identified following completion of the investigation, the additional relevant information will be submitted in a supplemental report.

• 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 NA 76892 3; SN 768923
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; +1(224)270-5355
• MDR Report Key: 50015178
• Report Number: 3008145987-2026-00059
• Device Sequence Number: 21467558
• Product Code: NHJ
• UDI-Device Identifier: 00887761984578
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K192143
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Type of Report: Initial
• Report Date (Section B): 07/23/2026

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: Other
• Device Model Number: M08594
• Device Catalogue Number: M08594
• Device Lot Number: N/A
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2026
• Initial Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 81 YR
• Patient Sex: Female