BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCTIC SUN® 5000

    MDR report key: 20248559 · Received September 18, 2024

    Report

    Report Number
    1018233-2024-05839
    Event Type
    Malfunction
    Date Received
    September 18, 2024
    Date of Event
    September 11, 2024
    Report Date
    October 29, 2024
    Manufacturer
    MEDIVANCE, INC. ¿ 1725056
    Product Code
    DWJ
    PMA / PMN Number
    K161602
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE REPORTED PRODUCT NUMBER IS SOLD OUS. THE UDI NUMBER FOR THIS PRODUCT IS NOT AVAILABLE. 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 REPORTED ISSUE WAS CONFIRMED. THE ROOT CAUSE OF THE REPORTED ISSUE IS A FAILED CONTROL PANEL. THE DEVICE WAS EVALUATED UPON RECEIPT. A DHR REVIEW IS NOT REQUIRED AS THE REPORTED EVENT IS NOT AN OUT OF BOX FAILURE AND THEREFORE THE REPORTED EVENT IS NOT MANUFACTURING RELATED. THE COMPLAINT OR REPORTED ISSUE WAS CONFIRMED THROUGH OTHER ELEMENTS OF THE INVESTIGATION TO NOT BE LABELING OR PACKAGING RELATED. THE REPORTED PRODUCT NUMBER IS SOLD OUS. THE UDI NUMBER FOR THIS PRODUCT IS NOT AVAILABLE. 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 ARCTIC SUN DEVICE DID NOT BOOT WHEN POWERED ON. PER ADDITIONAL INFORMATION REPORTED AGAINST SPARE PART 40308200, THE CONTROL PANEL REPORTED UNDER OUR REFERENCE NUMBER 24-2400 WAS DEFECTIVE UPON DELIVERY, SO THE SAME DEFECT OCCURRED WITH THE CONTROL PANEL THAT WAS DELIVERED INSTEAD. WHEN THE POWER WAS TURNED ON AGAIN AFTER ABOUT AN HOUR OF OPERATION, IT WOULD NOT START. WHEN THE POWER WAS TURNED ON AFTER WAITING ABOUT 2 MINUTES, IT WOULD START, BUT WHEN IT WAS OPERATED, IT WOULD NOT START. SYSTEM TIME 1914H, PUMP TIME 1774H, AND SYSTEM PUMP.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ARCTIC SUN DEVICE DID NOT BOOT WHEN POWERED ON. PER FOLLOW UP INFORMATION RECEIVED VIA MAIL ON 17SEP2024, IT WAS REPORTED THAT THE DEVICE WAS UNDER INVESTIGATION AND CASE COMPLETED WITH ANOTHER DEVICE. IT WAS REPORTED THAT THE CONTROL PANEL REPORTED UNDER REFERENCE NUMBER (B)(4) WAS DEFECTIVE UPON DELIVERY, SO THE SAME DEFECT OCCURRED WITH THE CONTROL PANEL THAT WAS DELIVERED INSTEAD. WHEN THE POWER WAS TURNED ON AGAIN AFTER ABOUT AN HOUR OF OPERATION, IT WOULD NOT START. WHEN THE POWER WAS TURNED ON AFTER WAITING ABOUT 2 MINUTES, IT WOULD START, BUT WHEN IT WAS OPERATED, IT WOULD NOT START. SYSTEM TIME WAS 1914H AND PUMP TIME WAS 1774H. PER FOLLOW UP INFORMATION RECEIVED VIA EMAIL ON 19SEP2024, THE DEVICE WAS SENT TO US. UNKNOWN ABOUT REPAIR AND ISSUE WAS RESOLVED OR NOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1302775 ARCTIC SUN® 5000 ARCTIC SUN DEVICE DWJ MEDIVANCE, INC. ¿ 1725056 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other