MAUDE Adverse Event Report: SMART FITNESS EMS FOR BOOT TONING; STIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING

Device Problem Use of Device Problem (1670)

Patient Problem Tachycardia (2095)

Event Date 06/20/2023

Event Type  malfunction  

Event Description

Used the smart fitness ems toner for 6 minutes and 59 seconds and noticed irregular fast heart beats, i removed immediately.The target time was 12 minutes.This item was purchased off wish.Refer to add'l documents in i2k.

• Brand Name: SMART FITNESS EMS FOR BOOT TONING
• Type of Device: STIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING
• MDR Report Key: 17203812
• MDR Text Key: 318047176
• Report Number: MW5118850
• Device Sequence Number: 1
• Product Code: NGX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/20/2023

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
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/23/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 36 YR
• Patient Sex: Female
• Patient Weight: 57 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American