MAUDE Adverse Event Report: SHENZHEN VIATOM TECHNOLOGY CO., LTD. VISUALBEAT; ELECTROCARDIOGRAPH

Model Number EP1

Device Problem Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/25/2021

Event Type  Injury  

Event Description

Wearing the wellue visualbeat device, it started reading a very high and then a very low and ultimately a completely unreliable heart rate.I know it's a small thing but i have an issue with my heart.When i see my heart rate fluctuating wildly in the middle of a workout, it causes a lot of anxiety, my heart races and i get into this feedback loop.I suspect the wellue device was malfunctioning because the electric monitor on exercise equipment and the optical monitor on a fitness tracker on my wrist measured a normal heart rate.Subsequent measurements made with the visualbeat device confirmed that the device was failing.The device has been in use for about 6 months.Fda safety report id# (b)(4).

• Brand Name: VISUALBEAT
• Type of Device: ELECTROCARDIOGRAPH
• Manufacturer (Section D): SHENZHEN VIATOM TECHNOLOGY CO., LTD.
• MDR Report Key: 12719465
• MDR Text Key: 279279420
• Report Number: MW5105021
• Device Sequence Number: 1
• Product Code: DPS
• 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: 10/27/2021

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
• Device Model Number: EP1
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/28/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 46 YR
• Patient Weight: 127