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 Codes	Cyanosis (1798); Respiratory Tract Infection (2420)
Date of Event	04/06/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Baxter has contacted the account requesting the device to be returned for inspection.The device was not available for evaluation, thus the allegation of patient tuned blue, eyes rolled back into head after treatment was not able to be confirmed or refuted.The customer chose to remain with the device at this time because they believe therapy protocol change will correct the issue.The synclara cough system is intended for use on patients who are unable to cough or clear secretions effectively due to reduced peak cough expiratory flow or respiratory muscle weakness.The synclara cough system provides a noninvasive therapy designed for use by patients, caregivers, and healthcare providers.The system will simulate a cough to remove secretions in patients with a compromised peak cough flow.Possible adverse conditions listed in the device instructions for use include swallowing too much air resulting in the likelihood of vomiting and aspiration.The use of a face mask may result in discomfort, vomiting, or breathlessness in some patients.Close supervision throughout the treatment is necessary when this product is used by children or patients with physical limitations or impaired cognitive abilities.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that patient had a cyanotic episode after synclara therapy was performed.It was noted that the customer was trained during initial set up to pause after 5 breaths; however, it was reported during the session that the patients¿ face turned blue the customer completed 10 breaths in a row.Two days later the patient had a fever and a cold where patient was prescribed antibiotics.The ifu of the device mentions that the use of a face mask may result in discomfort, vomiting, or breathlessness in some patients.Close supervision throughout the treatment is necessary when this product is used by children or patients with physical limitations or impaired cognitive abilities.There was no report of malfunction of the synclara device.The device remains with the patient, who will resume its use, decreasing the therapy cycles performed before a break.No further information was available at the time of this report.

• 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 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: 25144135
• Report Number: 3008145987-2026-00034
• Device Sequence Number: 9325701
• Product Code: NHJ
• UDI-Device Identifier: 00887761984554
• UDI-Public: (01)00887761984554
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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
• Report Date (Section B): 05/11/2026

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: Other
• 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: 04/15/2026
• Initial Report FDA Received Date: 05/11/2026
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 8 MO
• Patient Sex: Male