BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCTIC SUN® 5000

    MDR report key: 22078952 · Received May 23, 2025

    Report

    Report Number
    1018233-2025-03836
    Event Type
    Malfunction
    Date Received
    May 23, 2025
    Date of Event
    February 24, 2025
    Report Date
    May 21, 2025
    Manufacturer
    MEDIVANCE, INC. ¿ 1725056
    Product Code
    DWJ
    UDI-DI
    00801741127755
    PMA / PMN Number
    K161602
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED ISSUE WAS CONFIRMED. 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. PER ADDITIONAL INFORMATION RECEIVED, PER SMX WO CHATTER RESPONSE. THAT WAS A KNOWN ISSUE FROM A PRIOR FIELD ACTION, AND THEY SEND OUT REPLACEMENT PANELS FOR THOSE DEVICES AFFECTED. BIOMED RECEIVED A CONTROL PANEL AT NO CHARGE. LABELING REVIEW IS NOT REQUIRED BECAUSE LABELING COULD NOT HAVE PREVENTED THIS ISSUE. 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 STATED THE ARCTIC SUN DEVICE CAME DOWN FOR THE 6-MONTH PREVENTIVE MAINTENANCE AND THEY DID A TOUCHSCREEN CALIBRATION BECAUSE IT WASN'T RESPONDING AND NOW THE SCREEN WAS FLIPPED. PER FOLLOW UP INFORMATION RECEIVED VIA TASK ON 02APR2025, PER SMX WO CHATTER RESPONSE. THAT WAS A KNOWN ISSUE FROM A PRIOR FIELD ACTION, AND THEY SEND OUT REPLACEMENT PANELS FOR THOSE DEVICES AFFECTED. BIOMED RECEIVED A CONTROL PANEL AT NO CHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1070017 ARCTIC SUN® 5000 ARCTIC SUN DEVICE DWJ MEDIVANCE, INC. ¿ 1725056 NA 00801741127755

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other