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	Pneumothorax (2012)
Date of Event	09/21/2025
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 sustained a spontaneous pneumothorax with a volara system.On the date of the event, the patient completed their regular volara treatment at 00:06 without incident.The patient reported they were ¿getting ready for bed¿ and allegedly became ¿short of breath and had pain in their lung.¿ the patient ¿did not think much of it,¿ due to their history of lung pain.The following day, the patient still felt ¿extremely short of breath with lung pain¿ and an ambulance was called.The patient was admitted to hospital.While hospitalized the patient was found to have a collapsed left lung which required a chest tube and received unspecified medical treatment.The patient was discharged eight days later.The patient confirmed that they will not be using the volara device until they received clearance from their pulmonologist.Furthermore, based on the patient¿s history of experiencing pneumothorax episodes six years prior to use of the device and also again while volara therapy was paused, it can be reasonably concluded that the reported event was likely due to pathophysiology of the patient¿s medical condition.No further information was provided.
Additional Manufacturer Narrative
Additional information: h11: the device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.The device underwent end of life functional testing and performed according to product specifications.A device history review revealed no issues that could have caused or contributed to the reported issue.The reported condition was not verified.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: 23425338
• Report Number: 3008145987-2025-00018
• Device Sequence Number: 18206194
• Product Code: NHJ
• UDI-Device Identifier: 00887761984578
• UDI-Public: (01)00887761984578(11)240531
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: M08594
• Device Catalogue Number: M08594
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2025
• Supplement Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 10/30/2025
• Supplement Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/31/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Female