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

Model Number	M08575
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Baxter received a report stating that synclara filter was cracked.The device was located at the home and occurred during patient use.There was no patient/user injury, medical intervention, symptom, or adverse event reported.
Additional Manufacturer Narrative
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.Baxter has contacted the account three times requesting the device to be returned for inspection.The account was unresponsive to the attempts and the device did not return to manufacture.Therefore, baxter is completing this complaint due to the amount of time.Based on this information, no further action is required.Although there was no reported injury with this event, if the report of a synclara filter being cracked were to recur, it could potentially cause serious injury or death.Therefore baxter is reporting this event.

• 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: 22347451
• Report Number: 2183816-2025-00036
• Device Sequence Number: 8573373
• Product Code: NHJ
• UDI-Device Identifier: 00887761984554
• UDI-Public: (01)00887761984554
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 06/27/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: M08575
• Device Catalogue Number: M08575
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2025
• Initial Report FDA Received Date: 06/27/2025
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown