BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCTIC SUN STAT

    MDR report key: 19770825 · Received July 18, 2024

    Report

    Report Number
    1018233-2024-04291
    Event Type
    Malfunction
    Date Received
    July 18, 2024
    Date of Event
    July 1, 2024
    Report Date
    October 16, 2024
    Manufacturer
    MEDIVANCE, INC. ¿ 1725056
    Product Code
    DWJ
    UDI-DI
    00801741161513
    PMA / PMN Number
    K200225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    THE REPORTED ISSUE WAS CONFIRMED. THE ROOT CAUSE OF THE REPORTED ISSUE WAS ISOLATED TO A FAILED HOT GAS BYPASS VALVE FAILING TO OPEN. THE ARCTIC SUN STAT WAS EVALUATED UPON RECEIPT. DURING THE EVALUATION, THE ARCTIC SUN DEVICE WAS FOUND TO NOT COOL. HOT GAS BYPASS VALVE WAS FOUND STUCK CLOSED CAUSING THE UNIT NOT TO COOL. CHILLER UNIT WAS REPLACED. OBF CONVERTED TO A LOANER WITH NEW CLEAR LABELS. OBF CONVERTED TO A LOANER WITH NEW CLEAR LABELS. A FINAL INSPECTION WAS PERFORMED. THE ARCTIC SUN 6000 STAT PASSED ALL PERFORMANCE TESTING, AND ELECTRICAL SAFETY TESTS AND IS FUNCTIONING PROPERLY AND READY FOR USE. A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT SHOW ANY PROBLEMS OR CONDITIONS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. THE COMPLAINT OR REPORTED ISSUE WAS CONFIRMED THROUGH OTHER ELEMENTS OF THE INVESTIGATION TO NOT BE LABELING OR PACKAGING RELATED. CORRECTIONS: D, E, F, G, H 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 ARCTIC SUN DEVICE WAS NOT COOLING. HAD THEM READ T4 AND IT OVER 10 MINUTES FOR T4 TO GET BELOW 10C. THEN ONCE THEY INITIATED A FUNCTIONAL VERIFICATION, T2 WOULD NOT DROP BELOW 15 MINUTES. DISCUSSED THAT WAS INDICATIVE OF A CHILLER FAILURE. STATED THEY WOULD CLASSIFY THIS AS AN OBF AND SHIP A REPLACEMENT DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ARCTIC SUN DEVICE WAS NOT COOLING. HAD THEM READ T4 AND IT OVER 10 MINUTES FOR T4 TO GET BELOW 10C. THEN ONCE THEY INITIATED A FUNCTIONAL VERIFICATION, T2 WOULD NOT DROP BELOW 15 MINUTES. DISCUSSED THAT WAS INDICATIVE OF A CHILLER FAILURE. STATED THEY WOULD CLASSIFY THIS AS AN OBF AND SHIP A REPLACEMENT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2172627 ARCTIC SUN STAT ARCTIC SUN DEVICE DWJ MEDIVANCE, INC. ¿ 1725056 NA 00801741161513

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other