MAUDE Adverse Event Report: VivaQuant Inc Rhythm Express RX-1 Mini; Cardiac Monitor

Model Number	RX-1 Mini
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	Blister (4537)
Date of Event	12/11/2025
Type of Reportable Event	Malfunction

• Brand Name: Rhythm Express RX-1 Mini
• Common Device Name: Cardiac Monitor
• Manufacturer (Section D): VivaQuant Inc; 1265 grey fox rd; suite 400; arden hills MN 55112
• Manufacturer (Section G): VivaQuant Inc; 1265 grey fox rd; suite 400; arden hills MN 55112
• Manufacturer Contact: mark swanson ; 1265 grey fox rd; suite 400; arden hills, MN 55112 ; +1(763)234-0727
• MDR Report Key: 50166350
• Report Number: 3011937459-2026-04168
• Device Sequence Number: 5305298
• Product Code: DSI
• UDI-Device Identifier: 00860000272407
• UDI-Public: 00860000272407
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K200833
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/12/2025

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: RX-1 Mini
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/05/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 08/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2024
• 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: 47 YR
• Patient Sex: Female
• Patient Race: White