MAUDE Adverse Event Report: ELECTROMED, INC. SMARTVEST; SMARTVEST SQL

Model Number	SQL-R
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blister (4537)
Date of Event	03/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device, along with the user-provided vest and hose, was returned and evaluated.Functional testing, including external surface temperature measurement, was conducted with the user-supplied components.The evaluation confirmed that the maximum external surface temperature remained within established safety thresholds as defined by iec 60601-1 medical electrical equipment part 1: general requirements for basic safety and essential performance.The reported overheating condition could not be duplicated during testing.
Event or Problem Description
The manufacturer received a user complaint alleging the device overheated, causing the tubing and metal coupling to become hot and resulting in a blister on the user's abdomen.

• Brand Name: SMARTVEST
• Common Device Name: SMARTVEST SQL
• Manufacturer (Section D): ELECTROMED, INC.; 502 sixth ave nw; new prague MN 56071
• Manufacturer (Section G): ELECTROMED, INC.; 502 sixth ave nw; new prague MN 56071
• Manufacturer Contact: amy yanta ; 502 sixth avenue; new prague, MN 56071
• MDR Report Key: 21869620
• Report Number: 3003007907-2025-00001
• Device Sequence Number: 7916654
• Product Code: BYI
• UDI-Device Identifier: B102090488S0110
• UDI-Public: B102090488S0110
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K132794
• 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: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 04/18/2025

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: SQL-R
• Device Catalogue Number: SQL-R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/28/2025
• Initial Report FDA Received Date: 04/18/2025
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female