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	Low Oxygen Saturation (2477); Aspiration Pneumonitis (4455)
Date of Event	06/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported a patient developed aspiration pneumonia with low oxygen saturation after use of a synclara cough system.Reportedly after approximately one hour after the patient completed synclara device therapy, the patient began to breathe heavily, and their oxygen saturation measured 80% spo2.The patient was taken to the hospital and was admitted for ¿developing aspiration pneumonia.¿ this diagnosis was not confirmed to be attributed to the use of the synclara device.In the hospital the patient was placed on bipap the first two days and then returned to room air, no additional treatment was provided.It is also noted that the patient received 6l oxygen while hospitalized; however, it is unknown if the oxygen was used as simultaneous supplementation with the bipap device or singularly.Five days after admission to the hospital the patient was discharged.Although the synclara device was not in use at the time of the desaturation, it is undetermined at this time whether the earlier treatment contributed to the aspiration pneumonia.There was no allegation of a malfunction of the synclara device.No further information was available at the time of this report.
Additional Manufacturer Narrative
Additional information: h6 and h11.H11: the device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.The device underwent end of life functional testing and performed according to product specifications.A device history review revealed no issues that could have caused or contributed to the reported issue.The reported condition was not verified.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: 22371233
• Report Number: 2183816-2025-00037
• Device Sequence Number: 18130816
• Product Code: NHJ
• UDI-Device Identifier: 00887761984554
• UDI-Public: (01)00887761984554(11)241216
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2026

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: Lay User/Patient
• Device Model Number: M08575
• Device Catalogue Number: M08575
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2025
• Supplement Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 07/01/2025
• Supplement Report FDA Received Date: 02/11/2026
• 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: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NON-BAXTER OSCILLATION VEST DEVICE.
• Patient Age: 14 YR
• Patient Sex: Male