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

Model Number	M08575
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	05/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was experiencing an acute illness (rhinovirus and enterovirus) and used the synclara cough system to clear secretions; however, the device provided a 003 error that was unable to be resolved (unable to clear with troubleshooting).The patient¿s oxygen saturation dropped, and the patient was brought to the hospital.The patient healthcare provided informed baxter that had the synclara worked properly, the patient would have been able to clear their secretions, would not have experienced oxygen desaturation and therefore would not have required hospitalization.No details of the treatments performed in the hospital were provided.At the time of this report, the patient has since returned home from the hospital and has received a replacement synclara device.No additional information is available.
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.The device ifu states: ¿if the circuit and/or the smart-filter are damaged or visibly soiled, replace them.¿ the device involved in this event was returned for inspection.An event history log review was performed, and it was confirmed that there were multiple instances of errors 003 and 016 in the memory.Visual inspection revealed evidence of fluid ingress within the device, which likely caused the reported error codes.The fluid was dry by the time the device was returned for analysis, and the device was able to run plan4 therapy (therapy most common in the therapy logs) and passed end of line testing.Fluid ingress is usually caused by the patient circuit¿s filter becoming soiled.The patient circuit involved in this event was not returned with the device.Furthermore, it was noted that the patient performed synclara therapy above the number of therapies prescribed per day, and that their healthcare provider is aware of this.The patient¿s prescription calls for 6 circuits per month.Prior to the reported event, the patient received 14 circuits during the months of (b)(6) 2025.It was determined that the reported error code was due to fluid ingress, which is commonly caused by the patient circuit¿s filter becoming soiled.The patient was reported to be infected with rhinovirus and enterovirus which was likely not caused by the device, however, at this time, the device and/or use error (not changing soiled filter, therapy performed more than the amount prescribed) cannot be ruled out in potentially contributing to the inability to clear secretions and ultimate hospitalization.Prevention of this type of events is outlined in the device ifu.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.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: 22394193
• Report Number: 2183816-2025-00040
• Device Sequence Number: 9070076
• Product Code: NHJ
• UDI-Device Identifier: 00887761984554
• UDI-Public: (01)00887761984554(11)240723
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/03/2025

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2024
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 5 YR
• Patient Sex: Male