BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCTIC SUN® 5000

    MDR report key: 23037514 · Received September 12, 2025

    Report

    Report Number
    1018233-2025-07983
    Event Type
    Malfunction
    Date Received
    September 12, 2025
    Date of Event
    August 29, 2025
    Report Date
    September 11, 2025
    Manufacturer
    MEDIVANCE, INC. ¿ 1725056
    Product Code
    DWJ
    UDI-DI
    00801741080142
    PMA / PMN Number
    K161602
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED ISSUE WAS CONFIRMED. PER CAPA#: 2440507 AND SA#: UCC-21-4055-SA, "THE ROOT CAUSE OF THE SITUATION IS A BUG IN THE GDU AND INCOMPLETE INSTRUCTIONS AT AXIOMTEK. SOME OF THE ASSEMBLY TECHNICIANS USE THE GDU TO ROTATE THE SCREEN ORIENTATION FROM 0 TO 180 DEGREES DURING ASSEMBLY FOR OPERATIONAL EASE, SINCE THE ARCTICSUN CONTROL PANEL IS HELD UPSIDE DOWN IN THE PRODUCTION JIG. IF THE SETTING IS NOT REVERTED TO 0 DEGREES AFTER ASSEMBLY, IT WILL CAUSE FLIPPED TOUCHPOINTS. SCREEN SETUP PARAMETERS ARE NOT CONTROLLED AND A BUG IN THE GDU CAUSED TEMPORARY PARAMETERS TO BE SAVED, WHICH ALLOWED THIS BEHAVIOUR TO OCCUR. AXIOMTEK TO COMPLETE ACTION ACTIVITIES IN DY-SCAR-2020-004." THE DEVICE WAS EVALUATED UPON RECEIPT. THE TOUCHSCREEN IS INVERTED AND NOT RESPONDING CORRECTLY. A VIDEO WAS ATTACHED BY THE SERVICE TECHNICIAN SHOWING INVERTED TOUCHPOINTS. THE CONTROL PANEL WILL BE SCRAPPED AND WAS REPLACED WITH NEW CONTROL PANEL. PASSED THE ELECTRICAL SAFETY TESTING AND IS NOW READY FOR USED. A DHR REVIEW IS NOT REQUIRED AS THE COMPLAINT IS ADDRESSED BY EXISTING CAPA. LABELING/PACKAGING REVIEW IS NOT REQUIRED BECAUSE LABELING COULD NOT HAVE PREVENTED THIS ISSUE. CAPA#: 2440507 HAS BEEN OPENED FOR THIS FAILURE. 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 BIOMED REPORTED ALARM 47 POPS UP ON THE ARCTIC SUN DEVICE SCREEN, TRIED TO REBOOT BUT THE PROBLEM PERSISTED. PER REVIEW OF WO, NO PATIENT INVOLVEMENT. ALARM POPS UP DURING THE GENERAL MAINTENANCE. PER SAMPLE EVALUATION RESULTS ON 29AUG2025, THE TOUCHSCREEN WAS INVERTED AND NOT RESPONDING CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2305677 ARCTIC SUN® 5000 ARCTIC SUN DEVICE DWJ MEDIVANCE, INC. ¿ 1725056 NA 00801741080142

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other