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	Low Oxygen Saturation (2477)
Date of Event	01/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the clinical trainer that a school aged patient desaturated while using the volara system.The clinical trainer was setting up the volara for training on the patient and within 30 seconds of initiating the volara, the patient's oxygen saturation dropped to 56% while using the cpep mode on room air.The trainer stopped the therapy, and the patient¿s parental caregiver delivered ventilation with a bag valve mask (ambu bag).The patient's oxygen saturation increased above 90% without the need for supplemental o2 administration.The baxter clinical support specialist advised the trainer to use the chfo mode; however, within 30 seconds, the patient's oxygen saturation dropped again, to 76% on room air.The patient¿s parental caregiver had to bag the patient again.The patient's spo2 improved to the mid 90¿s% in less than 30 seconds.It was noted that the patient's baseline oxygen saturation values are in the mid 90's% on room air and utilizes supplemental oxygen only when required.Additionally, there was no report of a device malfunction.The exact cause is undetermined at this time; however, it can be reasonably concluded that the reported event was likely due to the pathophysiology of the patient's medical condition (spinal muscular atrophy with respiratory distress, chronic respiratory failure, ventilator dependency) and poor tolerance/suitability to the use of the device.The device will be returned.No additional information is available.
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional information: d9, h6 and h11.H11: the device was received for evaluation.During functional end of line testing the device failed neb pressure testing at 32.20psi (minimum passing value is 35psi).The neb base was replaced to correct the issue.The event history log review showed no keystrokes, programming, or use related events that indicated and/or contributed to the reported issue.A service history review was performed and revealed that the device has no previous service events; therefore, servicing did not cause or contribute to the reported event.

• 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 ST. PAUL; 1020 west county road f; st. paul MN 55126
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 21439055
• Report Number: 2183816-2025-00008
• Device Sequence Number: 11849502
• Product Code: NHJ
• UDI-Device Identifier: 00887761984578
• UDI-Public: (01)00887761984578(11)240826
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2025

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?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2025
• Supplement Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 02/21/2025
• Supplement Report FDA Received Date: 06/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/26/2024
• 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; Life Threatening
• Patient Age: 7 YR
• Patient Sex: Male