BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN ARCTICGEL PADS

    MDR report key: 24915781 · Received April 17, 2026

    Report

    Report Number
    1018233-2026-02554
    Event Type
    Malfunction
    Date Received
    April 17, 2026
    Date of Event
    April 14, 2026
    Report Date
    April 16, 2026
    Manufacturer
    MEDIVANCE, INC. ¿ 1725056
    Product Code
    DWJ
    PMA / PMN Number
    K142702
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER COMPLETE FACILITY NAME: (B)(6). THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CALLER TRYING TO START THERAPY AND GETTING NO FLOW IN AN ARCTIC SUN DEVICE. ACCORDING TO LOT THIS WAS AN X-SMALL KIT 3170302/(B)(6). DISCONNECTED AND RECONNECTED USING PROPER TECHNIQUE. RESTARTED THERAPY. DEVICE PRIMED AND STOPPED. DISCONNECTED THIS PAD AND CONNECTED NEW PADS. FLOW RATE (FR) WOULD NOT GET ABOVE 0.4LPM AFTER ADJUSTING TUBING AND TRYING DIFFERENT INLET PORTS. CONNECTED OLD PADS WITH EXTRA PADS OFF TO THE SIDE AND FLOW RATE (FR) WAS SETTLED AT 2LPM.PER FOLLOW UP INFORMATION RECEIVED VIA TASK ON 15APR2026, RESPONDENT ASKED WHAT UNIT WAS CALLING ABOUT. THEY WERE UNSURE WHAT 6TH FLOOR WAS REFERRING TO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    970050 UNKNOWN ARCTICGEL PADS ARCTIC GEL PADS DWJ MEDIVANCE, INC. ¿ 1725056 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other