BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCTIC SUN 5000

    MDR report key: 22194232 · Received June 12, 2025

    Report

    Report Number
    1018233-2025-04476
    Event Type
    Malfunction
    Date Received
    June 12, 2025
    Date of Event
    June 7, 2025
    Report Date
    August 20, 2025
    Manufacturer
    MEDIVANCE, INC. ¿ 1725056
    Product Code
    DWJ
    UDI-DI
    00801741080159
    PMA / PMN Number
    K161602
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED ISSUE WAS INCONCLUSIVE. AT THIS TIME, THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. THE MALFUNCTIONING DEVICE WAS PROMPTLY REPLACED WITH A FUNCTIONAL UNIT SOURCED FROM THE ADULT CARE DEPARTMENT TO ENSURE CONTINUITY OF PATIENT CARE. USER WAS GUIDED TO THE SETTINGS MENU AND ADJUSTED THE LOW WATER LEVEL (LWL) TO 10. THE HIGH-WATER LEVEL (HWL) WAS ALREADY SET TO 40°C, AS THE REPLACEMENT DEVICE WAS A STAT UNIT. REWARM TAB READS FROM 34.2°C TO 36.5°C AT A RATE OF 0.5°C PER HOUR. THE PATIENT¿S CURRENT TEMPERATURE WAS 33.8°C. THE USER REPORTED THAT THE RESERVOIR FELT COLD UPON RECEIVING THE DEVICE FROM THE ADULT UNIT BUT CONFIRMED THAT EVERYTHING APPEARS TO BE FUNCTIONING PROPERLY NOW. THE INSTRUCTIONS-FOR-USE ARE FOUND TO BE ADEQUATE. THE IFU CURRENTLY INSTRUCTS THE USER ON THE PROPER METHOD TO USE THIS DEVICE TO AVOID UNDUE INJURY TO THE PATIENT AND DAMAGE TO THE PRODUCT A DHR IS NOT REQUIRED AS THE DEVICE HAS UNDERGONE PREVIOUS SERVICING AND THEREFORE THE REPORTED ISSUE IS NOT MANUFACTURING RELATED. CORRECTION: D 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.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. 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 WHILE OPERATING THE SN: DYAVY113 ARCTIC SUN DEVICE, THE NICU NURSE ENCOUNTERED AN ERROR MESSAGE STATING. REQUESTED DATA NOT PLACED INTO MEMORY BECAUSE OF AN I/O ERROR. UPON ACKNOWLEDGING THE MESSAGE BY PRESSING ""OK,"" THE DEVICE SCREEN FROZE AND BECAME UNRESPONSIVE. THE MALFUNCTIONING DEVICE WAS PROMPTLY REPLACED WITH A FUNCTIONAL UNIT SOURCED FROM THE ADULT CARE DEPARTMENT TO ENSURE CONTINUITY OF PATIENT CARE. USER WAS GUIDED TO THE SETTINGS MENU AND ADJUSTED THE LOW WATER LEVEL (LWL) TO 10. THE HIGH-WATER LEVEL (HWL) WAS ALREADY SET TO 40°C, AS THE REPLACEMENT DEVICE WAS A STAT UNIT. REWARM TAB READS FROM 34.2°C TO 36.5°C AT A RATE OF 0.5°C PER HOUR. THE PATIENT¿S CURRENT TEMPERATURE WAS 33.8°C. THE USER REPORTED THAT THE RESERVOIR FELT COLD UPON RECEIVING THE DEVICE FROM THE ADULT UNIT BUT CONFIRMED THAT EVERYTHING APPEARS TO BE FUNCTIONING PROPERLY NOW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE OPERATING THE SN: (B)(6) ARCTIC SUN DEVICE, THE NICU NURSE ENCOUNTERED AN ERROR MESSAGE STATING. REQUESTED DATA NOT PLACED INTO MEMORY BECAUSE OF AN I/O ERROR. UPON ACKNOWLEDGING THE MESSAGE BY PRESSING ""OK,"" THE DEVICE SCREEN FROZE AND BECAME UNRESPONSIVE. THE MALFUNCTIONING DEVICE WAS PROMPTLY REPLACED WITH A FUNCTIONAL UNIT SOURCED FROM THE ADULT CARE DEPARTMENT TO ENSURE CONTINUITY OF PATIENT CARE. USER WAS GUIDED TO THE SETTINGS MENU AND ADJUSTED THE LOW WATER LEVEL (LWL) TO 10. THE HIGH-WATER LEVEL (HWL) WAS ALREADY SET TO 40°C, AS THE REPLACEMENT DEVICE WAS A STAT UNIT. REWARM TAB READS FROM 34.2°C TO 36.5°C AT A RATE OF 0.5°C PER HOUR. THE PATIENT¿S CURRENT TEMPERATURE WAS 33.8°C. THE USER REPORTED THAT THE RESERVOIR FELT COLD UPON RECEIVING THE DEVICE FROM THE ADULT UNIT BUT CONFIRMED THAT EVERYTHING APPEARS TO BE FUNCTIONING PROPERLY NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2032924 ARCTIC SUN 5000 ARCTIC SUN DEVICE DWJ MEDIVANCE, INC. ¿ 1725056 NA 00801741080159

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other