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	Bronchial Hemorrhage (4456)
Date of Event	03/10/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported a patient experienced ¿sudden significant lung bleeding¿ attributed to a volara system.The patient started using the volara system fourty seven days prior to the date of this report.Twelve days later the patient complained of a ¿sudden significant lung bleeding¿.The patient confirmed that the volara device was not used on the day of the event.The patient attended the hospital, and the patient underwent ¿a full-work-up¿ including a ct scan and was provided ¿medications and antibiotics.¿ it is also noted that the patient¿s hospital team instructed the patient to discontinue taking his prescribed eliquis, as well as discontinue use of the volara device.The patient confirmed that there were no device errors, and no allegation of malfunction.The device is being returned due to the patient¿s discontinuance of use.No further information was available at the time of this report.
Additional Manufacturer Narrative
The device was returned for evaluation related to the allegation of experiencing significant lung bleeding.Visual and functional resting passed.The performance specifications were verified in accordance with qs18838 using calibrated equipment.The device passed all test specifications and operated as designed.The allegation of experiencing significant lung bleeding was not confirmed.Event history log review did not find any logs that could contribute to this allegation.Manufacturing record review had no contributing factors to this allegation.These findings are in accordance with the ehlr, sar and mmr results.

• 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: 24802420
• Report Number: 3008145987-2026-00024
• Device Sequence Number: 18627924
• Product Code: NHJ
• UDI-Device Identifier: 00887761984578
• UDI-Public: (01)00887761984578
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 05/26/2026

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: Lay User/Patient
• 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: 03/10/2026
• Supplement Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 04/07/2026
• Supplement Report FDA Received Date: 05/26/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male