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

Model Number	M08575
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	05/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient reported that a patient experienced pneumothorax coincident with the use of a synclara therapy device.The patient was hospitalized for pneumothorax prior to the last training visit for the setup of a patient¿s new synclara device.The cause of the pneumothorax was unknown.The patient was using settings of +/-50, +5 pap, 1.4 second i-time, 1.8 second e time, 1 second pause time, 20 cycles at the time of incident.The patient was hospitalized for approximately one week.When admitted, the patient was placed on oxygen via face a mask.That evening, the patient was placed back on their non-baxter positive airway pressure (pap) machine with lower tidal volumes while they slept.The next morning, they were placed on room air.While hospitalized, they received xrays twice per day.They also noted a ct scan performed while hospitalized.After discharge, they had been following up with their pulmonologist weekly for an xray.The last xray, the pneumothorax was still present however much smaller.The patient was cleared by their pulmonologist and had been using their synclara with lower pressures.At the time of this report, the patient was continuing with the device therapy.The patient is now using pressures of +/-35, 1.4 second i-time, 1.8 second e time, 1 second pause time, 20 cycles and tolerating well.No additional information is available.
Additional Manufacturer Narrative
The device was not returned; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: SYNCLARA COUGH 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: 22420856
• Report Number: 2183816-2025-00041
• Device Sequence Number: 18405906
• Product Code: NHJ
• UDI-Device Identifier: 00887761984554
• UDI-Public: (01)00887761984554
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 07/07/2025

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: Lay User/Patient
• Device Model Number: M08575
• Device Catalogue Number: M08575
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 07/07/2025
• 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: BIPAP.; OXYGEN VIA FACE MASK.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 20 YR
• Patient Sex: Female