BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCTIC SUN® 5000

    MDR report key: 18551168 · Received January 22, 2024

    Report

    Report Number
    1018233-2024-00180
    Event Type
    Malfunction
    Date Received
    January 22, 2024
    Date of Event
    January 4, 2024
    Report Date
    February 7, 2024
    Manufacturer
    MEDIVANCE, INC. ¿ 1725056
    Product Code
    DWJ
    PMA / PMN Number
    K161602
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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 WAS ISOLATED TO A FAULTY T1 THERMISTOR. THE DEVICE WAS EVALUATED AND THE REPORTED ISSUE WAS CONFIRMED AS IT WAS NOTED THAT WHEN THE UNIT WAS POWERED ON AN ALARM 74 WAS DISPLAYED. THE TANK HARNESS WAS REPLACED. A DHR IS NOT REQUIRED AS THE REPORTED EVENT IS NOT AN OUT OF BOX FAILURE AND THEREFORE THE REPORTED EVENT IS NOT MANUFACTURING RELATED. THE REPORTED ISSUE WAS CONFIRMED THROUGH OTHER ELEMENTS OF THE INVESTIGATION TO NOT BE LABELING OR PACKAGING RELATED. CORRECTION: D, H 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 ACTUAL/SUSPECTED DEVICE WAS INSPECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ARCTIC SUN DEVICE CONTINUOUSLY RECEIVED ALARM 74. ALARM 74 WAS NON-RECOVERABLE SYSTEM ERROR - SECONDARY OUTLET WATER TEMPERATURE SENSOR OUT OF RANGE ¿ LOW RESISTANCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ARCTIC SUN DEVICE CONTINUOUSLY RECEIVED ALARM 74. ALARM 74 WAS NON-RECOVERABLE SYSTEM ERROR - SECONDARY OUTLET WATER TEMPERATURE SENSOR OUT OF RANGE ¿ LOW RESISTANCE. PER FOLLOW UP INFORMATION RECEIVED VIA EMAIL ON 18JAN2024. THE ISSUE WAS ALARM 74 OCCURRENCE. THE DEFECTIVE PART WAS TANK HARNESS, THE ISSUE WAS RESOLVED BY REPLACING TANK HARNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1579797 ARCTIC SUN® 5000 ARCTIC SUN DEVICE DWJ MEDIVANCE, INC. ¿ 1725056 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other