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	Transient Ischemic Attack (2109)
Date of Event	06/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient trained to minimal mode at 5 hz/10 % for 5 min with a gradual "minimal roadmap" ramp.Patient bypassed the recommended settings during training and set therapy to 8hz/15% for 15 mins.Patient reported the next day she experienced stroke-like symptoms, was transported to the hospital, and was diagnosed with a transient ischemic attack (tia).She was discharged after a few days and resumed normal activities.Patient did not want to return device and requested a smaller vest.Patient was informed to follow up with her medical doctor prior to continuing therapy.
Additional Manufacturer Narrative
Tia and hospitalization 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.
Additional Manufacturer Narrative
(b)(6) and hospitalization 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
Patient trained to minimal mode at 5 hz/10 % for 5 min with a gradual "minimal roadmap" ramp.Patient bypassed the recommended settings during training and set therapy to 8hz/15% for 15mins.Patient reported the next day she experienced stroke-like symptoms, was transported to the hospital, and was diagnosed with a transient ischemic attack (tia).She was discharged after a few days and resumed normal activities.Patient did not want to return device and requested a smaller vest.Patient was informed to follow up with her medical doctor 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: 22384897
• Report Number: 3003007907-2025-00002
• Device Sequence Number: 20998535
• 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): Y
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2025

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/24/2025
• Supplement Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 07/03/2025
• 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: Hospitalization
• Patient Sex: Female