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	Pneumothorax (2012)
Date of Event	03/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient, an 85-year-old with several pre-existing lung conditions including bronchiectasis, bronchiolitis, granulomatous lung disease, and a recent pseudomonas lung infection, was trained to use the smartvest on (b)(6) 2023.During the training, lower therapeutic settings were employed.The patient reported using the vest consistently from (b)(6) 2023, to (b)(6) 2024, without any issues.A compliance follow-up visit on december 22, 2023, revealed no problems; however, the patient expressed an intention to return the device.The patient decided to return the smartvest, stating that from (b)(6) 2023, to (b)(6) 2024, she used settings that ranged from 5 hz at 10% intensity for 5 minutes to 8 hz at 25% intensity for 5 minutes.She reported experiencing a lung collapse, which she stated her doctor felt it could be due to using the smartvest and to return the device.During electromed's follow up to this complaint, the patient's doctor stated the device was unlikely the cause for the patient's lung collapse.An inspection performed by a electromed technician noted that the device was functioning as designed, no malfunction was observed.There was no report of device malfunction and no malfunction of the device found during inspection or investigation.The exact cause of the reported event cannot be determined at this time, and the patient's injury was likely related to the patients pre-existing medical conditions, however, it cannot be excluded that the smartvest device contributed to the event.No further action is required.

• Brand Name: SMARTVEST
• Common Device Name: PERCUSSOR, POWERED-ELECTRIC
• 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 ave. n.w.; new prague, MN 56071
• MDR Report Key: 19229502
• Report Number: 3003007907-2024-00001
• Device Sequence Number: 6864920
• 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
• Report Date (Section B): 05/01/2024

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/08/2024
• Initial Report FDA Received Date: 05/02/2024
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 85 YR
• Patient Sex: Female