MAUDE Adverse Event Report: ELECTROMED, INC. SMARTVEST; PERCUSSOR, POWERED-ELECTRIC

Model Number	CLEARWAY-HOM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Atrial Fibrillation (1729)
Date of Event	08/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Atrial fibrillation reported by patient; no device malfunction alleged and device will not be returned at time of reported event.Device instructions for use include contraindications for use that require an individualized clinical assessment and careful consideration by the physician prior to prescription.
Event or Problem Description
During therapy, patient experienced dizziness and therapy was stopped.Kardiamobile was utilized and detected the patient had atrial fibrillation with a heart rate of 141.The symptoms had resolved once therapy was stopped.The patient was advised to stop therapy and speak with the cardiologist prior to continuing therapy.

• Brand Name: SMARTVEST
• Common Device Name: PERCUSSOR, POWERED-ELECTRIC
• Manufacturer (Section D): ELECTROMED, INC.; 502 sixth avenue nw; new prague MN 56071
• Manufacturer (Section G): ELECTROMED, INC.; 502 sixth avenue nw; new prague MN 56071
• Manufacturer Contact: megan gohman ; 502 sixth avenue nw; new prague, MN 56071
• MDR Report Key: 22738852
• Report Number: 3003007907-2025-00003
• Device Sequence Number: 7218503
• Product Code: BYI
• UDI-Device Identifier: B102125003S0100
• UDI-Public: B102125003S0100
• Combination Product (Y/N): N
• PMA/510(K) Number: K222496
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/07/2025

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: CLEARWAY-HOM
• Device Catalogue Number: 125003-S-010
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/01/2025
• Initial Report FDA Received Date: 08/07/2025
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female