BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCTIC SUN® 5000

    MDR report key: 17691931 · Received September 6, 2023

    Report

    Report Number
    1018233-2023-06611
    Event Type
    Malfunction
    Date Received
    September 6, 2023
    Date of Event
    August 21, 2023
    Report Date
    December 12, 2023
    Manufacturer
    MEDIVANCE, INC. ¿ 1725056
    Product Code
    DWJ
    PMA / PMN Number
    K161602
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON FURTHER REVIEW, BD HAS DETERMINED THAT THIS MDR IS NOT REPORTABLE. 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.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. 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. H3 OTHER TEXT : THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ARCTIC SUN DEVICE WHEN TURNING ON THE POWER. THE SCREEN SHOWS IN BIOS MODE AND ENTER PASSWORD. POSSIBLE COIN CELL BATTERY DEPLETED, PER REVIEW OF WO ON 21JUL2023, THERE WAS NO PATIENT INVOLVEMENT. AS PER FOLLOW UP INFORMATION RECEIVED ON 22SEP2023. THE DEVICE BE SENT IN FOR A BD-APPROVED FACILITY FOR EVALUATION. CONTROL PANEL OF THIS UNIT IS SENT BACK TO DYMAX FOR REPAIR. WAITING FOR DYMAX TO REPAIR THE CONTROL PANEL. NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ARCTIC SUN DEVICE WHEN TURNING ON THE POWER. THE SCREEN SHOWS IN BIOS MODE AND ENTER PASSWORD. POSSIBLE COIN CELL BATTERY DEPLETED. PER REVIEW OF WO ON 21JUL2023, THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1831724 ARCTIC SUN® 5000 ARCTIC SUN DEVICE DWJ MEDIVANCE, INC. ¿ 1725056 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other