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	Atrial Fibrillation (1729)
Date of Event	01/10/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is ongoing, however if any additional relevant information is identified following the completion of the investigation, the additional relevant information will be submitted in a supplemental report.
Event or Problem Description
It was reported that patient developed atrial fibrillation (a-fib) after using the volara system.Patient called clinical support as her medication did not seem to be nebulizing fully.During the phone conversation the patient mentioned that three months ago they went to er via ambulance due to a-fib, this occurred two hours after using the volara device.The patient noted to have experienced ¿a couple more a-fib episodes while hospitalized¿ and the patient believed it was ¿due to the severity of her coughing¿.Four days after admission, the patient was discharged from the hospital, and was put on two heart medications and will be following up with a cardiologist.No additional treatment was reported, and will continue using the device.The patient¿s healthcare team was uncertain if the volara device caused or contributed to the event of atrial fibrillation.No further information was available at the time of this report.
Additional Manufacturer Narrative
The device was not returned since customer chose to remain with the device at this time.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 ; 2242705355
• MDR Report Key: 24811003
• Report Number: 3008145987-2026-00025
• Device Sequence Number: 16122819
• Product Code: NHJ
• UDI-Device Identifier: 00887761984578
• UDI-Public: (01)00887761984578(11)240323
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K192143
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2026

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2026
• Supplement Date Received by Manufacturer: 05/08/2026
• Initial Report FDA Received Date: 04/07/2026
• Supplement Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/23/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Female