BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCTIC SUN® 5000

    MDR report key: 21294410 · Received February 3, 2025

    Report

    Report Number
    1018233-2025-00518
    Event Type
    Malfunction
    Date Received
    February 3, 2025
    Date of Event
    January 27, 2025
    Report Date
    February 12, 2025
    Manufacturer
    MEDIVANCE, INC. ¿ 1725056
    Product Code
    DWJ
    PMA / PMN Number
    K161602
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED ISSUE WAS CONFIRMED. THE ROOT CAUSE IDENTIFIED IS A FAILED CHILLER. THE DEVICE WAS EVALUATED UPON RECEIPT. DEVICE DOES NOT PASS INITIAL EVALUATION WATER TEMPERATURE DOES NOT DROP TO 6 DEGREES CELSIUS. WATER TEMP REACHES 15 DEGREES CELSIUS. CUSTOMER DECLINED REPAIR. DEVICE PUT ON HOLD. THE INITIAL REPORTER'S PHONE NUMBER THAT IS PROVIDED IS (B)(6). 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 COMPLAINT OR REPORTED ISSUE WAS CONFIRMED THROUGH OTHER ELEMENTS OF THE INVESTIGATION TO NOT BE LABELING OR PACKAGING RELATED. CORRECTIONS: D, E, F, H. 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

    INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE COMPLETE INITIAL REPORTER FACILITY NAME AVAILABLE IS LKH FELDKIRCH MATERIAL MANAGEMENT. THE COMPLETE INITIAL REPORTER PHONE NUMBER AVAILABLE IS (B)(6). THE INITIAL REPORTER ZIP AVAILABLE IS (B)(6). 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 PER PREVENTIVE MAINTENANCE WATER TEMPERATURE DID NOT DROP TO 6 DEGREES CELSIUS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PER PREVENTIVE MAINTENANCE WATER TEMPERATURE DID NOT DROP TO 6 DEGREES CELSIUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1076291 ARCTIC SUN® 5000 ARCTIC SUN DEVICE DWJ MEDIVANCE, INC. ¿ 1725056 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other