BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RX-1 MINI RHYTHM EXPRESS REMOTE CARDIAC MONITORING SYSTEM

    MDR report key: 23386929 · Received October 25, 2025

    Report

    Report Number
    3011937459-2025-03527
    Event Type
    Malfunction
    Date Received
    October 25, 2025
    Date of Event
    September 17, 2025
    Report Date
    November 18, 2025
    Manufacturer
    VIVAQUANT, INC
    Product Code
    MLO
    UDI-DI
    00860000272407
    PMA / PMN Number
    K200833
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    INITIAL INVESTIGATION INDICATES WATER INGRESS INTO THE DEVICE. SOURCE IS NOT CLEAR.

    Description of Event or Problem · 0

    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.

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2045929 RX-1 MINI RHYTHM EXPRESS REMOTE CARDIAC MONITORING SYSTEM REMOTE CARDIAC MONITOR MLO VIVAQUANT, INC RX-1 MINI 00860000272407

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Other