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	08/11/2025
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 pediatric patient desaturated during use with a synclara cough system.The patient¿s parental caregiver received the synclara device and used it three times.Each time the patient¿s ¿oxygen saturation dropped significantly.¿ the patient¿s spo2 dropped the first time to 20%, the second time was 36% and the third time was 28% during synclara therapy.During each event, the patient ¿turned very purple within seconds of starting therapy.¿ additionally, per the patient¿s caregiver, the patient is ¿going through all 15 cycles without pausing.¿ once the mask was removed, ¿the patient recovered rather quickly back to their baseline spo2 of 97-98% on room air.¿ although the patient did not require medical intervention, the event is considered temporarily life-threatening due to the significant drop in oxygen saturation coupled with cyanosis (indicating deoxygenated hemoglobin).The device instructions for use state: ¿during the pause stage, have the patient breathe normally.Do the number of therapy cycles (inhale-exhale-pause) as recommended by the physician or by the patient group: (for children¿3-5 cycles)¿.The cause of the event is likely multifactorial and related to the patient¿s complex medical history and therapy intolerance related to use error (caregiver performing too many cycles without pausing, as outlined in the device ifu).Clinical support advised to do 3 cycles with the patient, then pause the device to allow the patient time to rest and recover before doing next set of 3 breaths.Clinical support will have a trainer visit the home to retrain on the device with pauses in therapy.Also, the trainer is to evaluate settings for patient tolerance and efficacy.A request for the trainer to review the error log and educate on error codes and evaluate device function.No further information was available at the time of this report.
Additional Manufacturer Narrative
Additional information: h6 and h11.H11: a device history review revealed no issues that could have caused or contributed to the reported issue.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.

• 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: 23004232
• Report Number: 3008145987-2025-00011
• Device Sequence Number: 9519048
• Product Code: NHJ
• UDI-Device Identifier: 00887761984554
• UDI-Public: (01)00887761984554(11)990204
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2026

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2025
• Supplement Date Received by Manufacturer: 01/25/2026
• Initial Report FDA Received Date: 09/09/2025
• Supplement Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (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: NI.
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 14 YR
• Patient Sex: Female