BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCTIC SUN® 5000

    MDR report key: 13877939 · Received March 24, 2022

    Report

    Report Number
    1018233-2022-01542
    Event Type
    Malfunction
    Date Received
    March 24, 2022
    Date of Event
    October 6, 2021
    Report Date
    March 9, 2022
    Manufacturer
    MEDIVANCE, INC. ¿ 1725056
    Product Code
    DWJ
    UDI-DI
    00801741080142
    PMA / PMN Number
    K161602
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED ISSUE WAS CONFIRMED. THE ROOT CAUSE OF THE REPORTED ISSUE WAS USER ERROR. THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE SERIAL NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: "FROM THE PATIENT THERAPY SELECTION SCREEN, PRESS THE NORMOTHERMIA BUTTON TO DISPLAY THE NORMOTHERMIA THERAPY SCREEN. THE DEFAULT PATIENT TARGET TEMPERATURE WILL DISPLAY IN THE CONTROL PATIENT WINDOW. TO MODIFY THE PATIENT TARGET TEMPERATURE, PRESS THE ADJUST BUTTON TO DISPLAY THE CONTROL PATIENT-ADJUST WINDOW. CONTROL PATIENT TO: USE THE UP AND DOWN ARROWS TO SET THE DESIRED PATIENT TARGET TEMPERATURE TO CONTROL THE PATIENT. REWARM AT A RATE OF: USE THE UP AND DOWN ARROWS ON THE RIGHT OF THE SCREEN TO SET THE REWARMING RATE. PRESS THE SAVE BUTTON TO SAVE THE NEW SETTINGS AND CLOSE THE CONTROL PATIENT-ADJUST WINDOW. PRESS START, IN THE CONTROL PATIENT WINDOW TO INITIATE THERAPY. YOU WILL HEAR A TONE AND THEN A VOICE STATING ¿THERAPY STARTED¿. ADDITIONALLY, THE CONTROL PATIENT WINDOW AND THE ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM ICON WILL BLINK, INDICATING THAT THERAPY IS IN PROGRESSAW 2800261 REV. 2 WAS REVIEWED AND 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." THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE THERAPY WAS STOPPED ON THE ARCTIC SUN DEVICE AND THE USER WANTED TO KNOW HOW TO RESTART IT. THE PATIENT TEMPERATURE WAS 33.9C AND THE TARGET TEMPERATURE WAS 33.5C. THE USER STATED THAT SOMEONE KNEW ABOUT THE DEVICE AND RESTARTED THE THERAPY. PER FOLLOW-UP INFORMATION RECEIVED ON 13OCT2021, THE NURSE STATED THAT THE ISSUE WAS A USER ERROR, AND THEY NEEDED HELP RESTARTING THE ARCTIC SUN DEVICE. THE THERAPY WAS ABLE TO BE COMPLETED SUCCESSFULLY WITH NO FURTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728291 ARCTIC SUN® 5000 ARCTIC SUN DEVICE DWJ MEDIVANCE, INC. ¿ 1725056 50000000 NA 00801741080142

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other