MAUDE Adverse Event Report: VIVAQUANT, INC RX-1 MINI RHYTHM EXPRESS REMOTE CARDIAC MONITORING SYSTEM

Model Number	RX-1 MINI
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	Blister (4537)
Date of Event	09/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Ibc from patient due to device not lighting up indicating a charge, tried soft reset and device isn't vibrating or lighting up.Device is unresponsive and patient stated that early this morning the housing of the device started to get very hot and now he has a blister under where the housing was sitting on his chest.
Additional Manufacturer Narrative
Initial investigation indicates water ingress into the device.Source is not clear.
Event or Problem Description
Call from patient due to device not lighting up indicating a charge, tried soft reset and device isn't vibrating or lighting up.Device is unresponsive and patient stated that early this morning the housing of the device started to get very hot and now he has a blister under where the housing was sitting on his chest.
Additional Manufacturer Narrative
Initial investigation indicated water ingress into the device.Source is not clear following a thorough investigation of the device rx323937 (77e66aca53) it appears that a small amount of liquid was inside the case of the rx-1 mini and resulted in shorting of one or more components and a heating of the outer surface of the housing.Diagnostic files downloaded from the device show that current was slightly elevated for about 90 minutes.It is estimated that the device housing temperature was likely elevated to about 45 deg c.A medical expert concluded that the impact of this warm temperature on tissue for extended period of time would result in a blister is consistent with exposure of the skin to ~45 deg c for 1.5 to 2 hours.The patient sought medical treatment for the blister that included antibiotic cream and broad-spectrum antibiotic treatment.No known side effects and the patient has no medically significant residual effects.

• Brand Name: RX-1 MINI RHYTHM EXPRESS REMOTE CARDIAC MONITORING SYSTEM
• Common Device Name: REMOTE 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
• MDR Report Key: 23386929
• Report Number: 3011937459-2025-03527
• Device Sequence Number: 21011992
• Product Code: MLO
• UDI-Device Identifier: 00860000272407
• UDI-Public: 00860000272407
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2025

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/30/2025
• Supplement Date Received by Manufacturer: 09/30/2025
• Initial Report FDA Received Date: 10/25/2025
• Supplement Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2024
• 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: 63 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White