MAUDE Adverse Event Report: VIVALNK VIVALINK CONTINUOUS ECG PLATFORM; RADIO TRANSMITTER AND RECEIVER

Model Number	VV330
Medical Device Problem Code	Missing Information (4053)
Health Effect - Clinical Codes	Arrhythmia (1721); Burn(s) (1757); High Blood Pressure/ Hypertension (1908)
Date of Event	02/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Retrospective record review and proactive reporting of incidents where available information is insufficient to confirm non-seriousness.
Event or Problem Description
The patient was plugging a non-vivalink extension cord into the electrical plug, at that moment a spark flew out, and the electric current ran through her entire body.There is a small burn on her left palm, where she held the wooden closet.After the electrical discharge current, she experienced subjective arrhythmia, headache, also measured hypertension up to 190/100 mmhg, took tensiomin 12.5 mg tablets.Ecg without acute ischemic changes.The patient complains that the instructions for use do not mention the need to be careful not only with water, but also with electricity.The patient believes that the long-term ekg recorder she was wearing at the time of the incident contributed to the electric shock.

• Brand Name: VIVALINK CONTINUOUS ECG PLATFORM
• Common Device Name: RADIO TRANSMITTER AND RECEIVER
• Manufacturer (Section D): VIVALNK; 51 e campbell ave; suite 160; campbell CA 95008
• Manufacturer Contact: quoi huynh ; 51 e campbell ave; suite 160; campbell, CA 95008 ; 4088682898
• MDR Report Key: 25894431
• Report Number: 3011651603-2026-00003
• Device Sequence Number: 15987679
• Product Code: DRG
• UDI-Device Identifier: 00865064000157
• UDI-Public: 00865064000157
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K191870
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/13/2024

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
• Device Expiration Date: 03/07/2024
• Device Model Number: VV330
• Device Catalogue Number: VV330
• Device Lot Number: C882114/202310
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/13/2024
• Initial Report FDA Received Date: 07/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2023
• 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
• Patient Sex: Female