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	06/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: 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.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported a child's oxygen saturation lowered with the use of a synclara cough system.The parental caregiver was trained on the use of the synclara device.The caregiver performed the initial set up of the synclara and the child tolerated therapy.After an unspecified amount of time while the child was sleeping, their spo2 dropped (o2 level not reported).The caregiver placed the child on 5lpm 02 per nasal cannula and the child's sp02 increased to 89%.The caregiver then woke the child up and the spo2 increased to "greater than 93%." the caregiver reportedly put the child on 3lpm of o2 via nasal cannula and the "spo2 remained at 93% overnight." according to the caregiver, the child no longer required oxygen and is unsure if the o2 level dropping was a result of the synclara use or from the patient¿s residual illness.The caregiver also reported that the patient started a new antibiotic (name and dose not reported) that same day.The caregiver planned to discuss the future use of the synclara device with the child's healthcare provider and will resume use per physician direction.There was no allegation of a device malfunction.No further information was available at the time of this report.

• 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: 22725354
• Report Number: 3008145987-2025-00002
• Device Sequence Number: 8989969
• Product Code: NHJ
• UDI-Device Identifier: 00887761984554
• UDI-Public: (01)00887761984554(241230
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/06/2025

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
• Device Catalogue Number: M08575
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 08/06/2025
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 5 YR
• Patient Sex: Male