MAUDE Adverse Event Report: ELECTROMED, INC. SMARTVEST SQL; HFCWO AIRWAY CLEARANCE DEVICE

Model Number	SQL_R
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	10/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received a complaint from a user stating recently the machine is heating up and it is burning hot when she turns it on.She said it would burn her hand if she left her hand there.The machine would then just power off.There was no reported injury.Manufacturers evaluation summary: the device was returned on (b)(6) 2022.Engineering evaluated the returned device and found no anomalies with the device on initial review.The device was then submitted for performance testing to final test specifications and passed all testing.The device was operated under normal operating conditions using patients device settings, the outside surface temperature of the device was measured, a temperature of 96.7 degrees f was recorded.We were unable to duplicate the complaint of device heating up and shutting off.The investigation was closed on 11/18/2022.

• Brand Name: SMARTVEST SQL
• Common Device Name: HFCWO AIRWAY CLEARANCE DEVICE
• Manufacturer (Section D): ELECTROMED, INC.; 500 sixth ave nw; new prague MN 56071
• Manufacturer (Section G): ELECTROMED, INC.; 500 sixth ave nw; new prague MN 56071
• Manufacturer Contact: gregory spurlock ; 500 sixth ave nw; new prague, MN 56071 ; 9527599299
• MDR Report Key: 16225135
• Report Number: 3003007907-2023-00001
• Device Sequence Number: 14770573
• Product Code: BYI
• UDI-Device Identifier: B102090488S0110
• UDI-Public: +B102090488S0110
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 01/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: SQL_R
• Device Catalogue Number: SQL_R
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2022
• Type of Report(Section G): Five-Day
• Initial Date Received by Manufacturer: 10/20/2022
• Initial Report FDA Received Date: 01/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2022
• 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 Age: 62 YR
• Patient Sex: Female
• Patient Weight: 121 KG