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	Low Oxygen Saturation (2477)
Date of Event	07/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient desaturated while utilizing a synclara cough system.A baxter respiratory trainer (brt) had completed the synclara set up for the patient with the parameters received.The synclara was set at ¿the lowest setting of +/-10¿, the patient turned red and their spo2 reading ¿dipped into the 70¿s.¿ the brt was unable to do an accurate evaluation of the patient¿s recovery time or how well they tolerated treatment due to the patient¿s caregivers becoming ¿nervous and anxious.¿ the caregivers immediately put the patient on oxygen, grabbed a stethoscope, and started doing manual chest physiotherapy on the patient.The brt was not convinced the waveform on the spo2 monitor is accurate due to the caregivers ¿messing¿ with the patient.It took approximately five minutes for the spo2 to ¿recover¿ back to the ¿prescribed range of 85-90%.¿ the caregivers requested the synclara device remain in the patient¿s home and to have the brt return the next week to ¿try the device again.¿ there was no allegation of a device malfunction.No further information was available at the time of this report.
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional information was added to d9, h3, and h6.H11: the device was received for evaluation.Functional testing and end of line testing were performed, and it was noted that all tests passed and the device ran an automatic low therapy without any issues.The reported condition was not verified.The event history log review showed no keystrokes, programming, or use related events that indicated and/or contributed to the reported issue.A device history review revealed no issues that could have caused or contributed to the reported issue.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 SINGAPORE; 1 yishun avenue 7; singapore, north east 76892 3; SN 768923
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 22874686
• Report Number: 3008145987-2025-00007
• Device Sequence Number: 5775892
• Product Code: NHJ
• UDI-Device Identifier: 00887761984554
• UDI-Public: (01)00887761984554(11)990121
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2026

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: Health Professional
• Device Model Number: M08575
• Device Catalogue Number: M08575
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2025
• Supplement Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 08/22/2025
• Supplement Report FDA Received Date: 01/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Life Threatening
• Patient Age: 7 MO
• Patient Sex: Male