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	04/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported using smartvest 2x daily for 3-4 days at 6-14 hz and 20-30% pressure for 15 minutes.Patient reported onset of back pain, discontinued use, and later required er evaluation with 1-day hospitalization (dates not provided).Ct imaging identified multiple spinal compression fractures.Patient was treated with a back brace and pain medication and later advised by a spine specialist to discontinue use; no causality determination was provided.Patient has a history of osteoporosis, a known risk factor for compression fractures.No device malfunction was reported.Device not available for evaluation as the patient declined return.Causality has not been established.
Additional Manufacturer Narrative
Event involves a patient with known osteoporosis who experienced spinal compression fractures following short-term device use.No device malfunction identified, and device not available for evaluation.Device instructions for use include contraindications requiring individualized clinical assessment by the prescribing physician.Based on available information, including the patient's underlying condition and absence of device-related findings, a causal relationship cannot be established.

• 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: april johnson ; 502 sixth avenue nw; new prague, MN 56071
• MDR Report Key: 25050057
• Report Number: 3003007907-2026-00002
• Device Sequence Number: 10324961
• Product Code: BYI
• UDI-Device Identifier: B102125003S0100
• UDI-Public: B102125003S0100
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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): 04/30/2026

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: 125003S010
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 04/30/2026
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Female