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	11/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Elevated heart rate and atrial fibrillation were reported by the patient.No device malfunction was alleged, and the device will not be returned for evaluation.The device instructions for use outline contraindications that require individualized clinical assessment and physician judgment prior to prescribing the therapy.
Event or Problem Description
The patient reported noticing an elevated heart rate after using the smartvest device.She stated her typical resting heart rate ranges from 60-80 bpm and that she observed readings of 118-133 bpm at rest.She did not report chest pain, shortness of breath, or additional symptoms.Per the patient's daughter, the cardiologist was not concerned with continued smartvest use as long as the patient's heart rate returned toward her usual baseline.The electromed respiratory therapist advised temporarily reducing therapy settings to allow the patient to acclimate.The patient later followed up with her cardiologist on (b)(6) 2025 and was noted to be experiencing atrial fibrillation/atrial flutter with low blood pressure.An ekg recorded a heart rate of approximately 130 bpm.Electromed was unable to obtain further clinical information to determine whether the reported cardiac findings were related to smartvest use.

• 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: 23771789
• Report Number: 3003007907-2025-00005
• Device Sequence Number: 21254560
• 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): 12/10/2025

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
• 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: 11/18/2025
• Initial Report FDA Received Date: 12/10/2025
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown