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

Model Number	M08594A
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Flow or Under Infusion (2182); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pneumonia (2011)
Date of Event	01/01/2026
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 around february the patient was diagnosed with cavitary pneumonia presumably due to volara device not functioning properly.It was reported that volara device has about two months not functioning properly, sounding quieter, less strong and different than it used to.Days after the event was reported, the volara and circuit was replaced by the trainer who noted the presence of water in the circuit and the nebulizer tubing during the retraining session.Patient's pulmonologist indicated the patient had pus in a cavity in his lung and was put on antibiotic.The patient was given a new device and therapy with the volara has been continued as prescribed.The exact cause of the event is unknown at the moment and no further information was available at the time of this report.
Additional Manufacturer Narrative
The device was received for evaluation.During evaluation, the nebulizer base module was observed to have low air flow and produce an abnormal sound; the reported condition was verified.The cause of the failure was determined to be degradation of internal components over time, resulting in reduced performance and failure to meet specifications.A review of the patient use and history indicates the device had been operating in this condition for an extended period, suggesting possible use or maintenance factors may have contributed.A service history review was performed and revealed no prior service events; therefore, servicing did not cause or contribute to the reported condition.The patient was provided with a replacement device and instructed to continue therapy.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: 24822656
• Report Number: 3008145987-2026-00026
• Device Sequence Number: 17678679
• Product Code: NHJ
• UDI-Device Identifier: 00887761981690
• UDI-Public: (01)00887761981690(11)200909
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2026

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: M08594A
• Device Catalogue Number: M08594A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2026
• Supplement Date Received by Manufacturer: 05/18/2026
• Initial Report FDA Received Date: 04/08/2026
• Supplement Report FDA Received Date: 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2020
• 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
• Patient Sex: Male