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

Model Number	M08594
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Glossitis (4490)
Date of Event	11/15/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4: unique identifier (udi) #: the manufacturing date (11) is not known at this time; therefore, the udi number only will contain the device identifier ((b)(4)) and serial number (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported the patient experienced thrush during use of volara system.The patient started using the volara system ninety four days prior to the date of this report.Seven days later the patient complained of a ¿hoarse voice¿.The patient continued using the device at lower device settings.Thirty one days later, the patient visited their dentist and was diagnosed with thrush.The dentist prescribed diflucan for two weeks.Nineteen days after the visit to the dentist, the patient visited an unknown doctor due to ¿persistent symptoms¿.The patient was advised to ¿stop using the volara system, re-access if not better then would need to see an ear nose and throat physician¿.The patient declines any machine malfunction.However, after a follow-up call by a respiratory clinician, found that the patient was not cleaning the volara device according to the device's instructions.The patient reported cleaning the device circuit 2-3 times since the initiation of therapy; though, has not changed the circuit.Additionally, the patient was not cleaning the device¿s mouthpiece, nebulizer cup, or the device¿s corrugated circuit tubing.The device¿s instructions for use state the following for clear and disinfecting the device and its components ¿clean the control unit, stand, and foot switch between therapy sessions, when visibly soiled, or according to facility protocols.Disconnect the patient circuit from the control unit.If a nebulizer is used, disconnect the nebulizer kit from the patient circuit.Disconnect all components of the patient circuit.Wash the components of the patient circuit (excluding the smart-filter) in liquid dishwashing soap and warm water.Rinse the components with clean water.Examine the components for any remaining traces of soil.If the components are not visibly clean, do step 3 to 5 again.Replace the patient circuit if there is remaining soil that cannot be removed.Let the components dry completely before use.Each patient circuit is intended for 30 days of treatment or a maximum of 90 treatment sessions.¿ there was no report of a device malfunction, and the device remains with the patient for continued use.No further information was available at the time of this report.
Additional Manufacturer Narrative
Additional information: h6 and h11.H11: 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.The device was not received for evaluation; 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 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: 21146407
• Report Number: 2183816-2025-00001
• Device Sequence Number: 9134949
• Product Code: NHJ
• UDI-Device Identifier: 00887761984578
• UDI-Public: (01)00887761984578
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2025

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?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2024
• Supplement Date Received by Manufacturer: 05/01/2025
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 05/29/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ALBUTEROL; BUDESONIDE
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown