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	Pneumonia (2011)
Date of Event	06/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient was hospitalized for pneumonia while using the synclara cough system therapy.The patient was subsequently discharged home, was reported to be doing well, and was cleared by the healthcare team to resume therapy.It was reported that the patient is nonverbal and frequently resisted therapy by fighting against the device, keeping his mouth closed, and holding his breath rather than following the intended inspiratory and expiratory therapy pattern.During treatment sessions, increased mucus production was reportedly observed, and therapy was paused to allow suctioning of secretions because the patient was unable to independently expectorate mucus.A baxter clinical support specialist coordinated retraining and recommended consultation with the patient's healthcare team to assess therapy effectiveness, review prescribed settings, and make any necessary adjustments to improve patient comfort and tolerance.There was no allegation or evidence of a device malfunction.The exact cause of the reported pneumonia remains unknown.Based on the available information, the event is most likely associated with the patient's underlying medical conditions and impaired respiratory status.The poor tolerance and resistance to synclara therapy, including failure to effectively participate in treatment and airway clearance activities, cannot be excluded as contributing factors.The device remains with the patient, who has been cleared to resume therapy following retraining and consultation with the healthcare team.No further information was available at the time of this report.
Additional Manufacturer Narrative
The device was not available for evaluation, thus the allegation of resistance to therapy was not able to be confirmed or refuted.The customer chose to remain with the device at this time.There was no allegation or evidence of a device malfunction.The synclara cough system is intended for patients who are unable to cough or clear secretions effectively due to reduced peak cough expiratory flow or respiratory muscle weakness.The device provides noninvasive therapy designed to simulate a cough and assist with secretion clearance in patients with compromised cough effectiveness.

• 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 NA 76892 3; SN 768923
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; +1(224)270-5355
• MDR Report Key: 50531460
• Report Number: 3008145987-2026-00072
• Device Sequence Number: 9875092
• Product Code: NHJ
• UDI-Device Identifier: 00887761984554
• UDI-Public: (01)00887761984554(11)000324
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K192143
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Type of Report: Initial
• Report Date (Section B): 08/31/2026

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
• Device Lot Number: N/A
• 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: 08/04/2026
• Initial Report FDA Received Date: 08/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/24/2000
• 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: Hospitalization; Required Intervention
• Patient Age: 22 YR
• Patient Sex: Male