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	Back pain (4895)
Date of Event	02/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was trained on the smartvest on 12/8, using settings 8-9-10 hz 25-20-30% for 5 min each on therapy1.She used the smartvest for about a month.She started having headaches and back issues, she began to experience mobility issues and started having difficulty walking.She went to a chiropractor who stated her back was out of alignment likely due to the smartvest.After several weeks of seeing the chiropractor she returned to baseline with no further issues.
Additional Manufacturer Narrative
No device malfunction alleged and device was returned and investigated to conclude no device issues were found.Device instructions for use include contraindications for use that require an individualized clinical assessment and careful consideration by the physician prior to prescription.

• 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: 24682603
• Report Number: 3003007907-2026-00001
• Device Sequence Number: 21326171
• 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): 03/24/2026

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
• Device Model Number: CLEARWAY-HOM
• Device Catalogue Number: 125003-S-010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Required Intervention; Other
• Patient Sex: Female