BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCTIC SUN® 5000

    MDR report key: 22512849 · Received July 15, 2025

    Report

    Report Number
    1018233-2025-05884
    Event Type
    Malfunction
    Date Received
    July 15, 2025
    Date of Event
    July 11, 2025
    Report Date
    August 11, 2025
    Manufacturer
    MEDIVANCE, INC. ¿ 1725056
    Product Code
    DWJ
    UDI-DI
    00801741127755
    PMA / PMN Number
    K161602
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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. 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 DEVICE WAS NOT RETURNED. THE REPORTED ISSUE WAS CONFIRMED. THE ROOT CAUSE OF THE REPORTED ISSUE IS A FAILED T4 THERMISTOR. BIOMED HAD DEVICE SENT DOWN FROM NEONATAL INTENSIVE CARE UNIT (NICU) WITH ALARM 78 (NON-RECOVERABLE SYSTEM ERROR). PER WO-00113234, HAD BIOMED LOOK AT T4 AND IT WAS READING 99.9 DEGREES, GAVE THE BIOMED THE PART NUMBER FOR A NEW TANK HARNESS. THE COMPLAINT OR REPORTED ISSUE WAS CONFIRMED THROUGH OTHER ELEMENTS OF THE INVESTIGATION TO NOT BE LABELING OR PACKAGING RELATED. 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. CORRECTION: D, F, 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 BIOMED HAD AN ARCTIC SUN DEVICE THAT WAS ALARMING 78 (NON-RECOVERABLE SYSTEM ERROR) WHEN POWERED ON. PER ADDITIONAL INFORMATION UPDATED FROM TTM ON 14JUL2025, BIOMED HAD DEVICE SENT DOWN FROM NEONATAL INTENSIVE CARE UNIT (NICU) WITH ALARM 78 (NON-RECOVERABLE SYSTEM ERROR) .

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BIOMED HAD AN ARCTIC SUN DEVICE THAT WAS ALARMING 78 (NON-RECOVERABLE SYSTEM ERROR) WHEN POWERED ON. PER ADDITIONAL INFORMATION UPDATED FROM TTM ON 14JUL2025, BIOMED HAD DEVICE SENT DOWN FROM NEONATAL INTENSIVE CARE UNIT (NICU) WITH ALARM 78 (NON-RECOVERABLE SYSTEM ERROR).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147299 ARCTIC SUN® 5000 ARCTIC SUN DEVICE DWJ MEDIVANCE, INC. ¿ 1725056 NA 00801741127755

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other