BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCTIC SUN® 5000

    MDR report key: 15886961 · Received November 30, 2022

    Report

    Report Number
    1018233-2022-09111
    Event Type
    Malfunction
    Date Received
    November 30, 2022
    Date of Event
    November 14, 2022
    Report Date
    April 17, 2023
    Manufacturer
    MEDIVANCE, INC. ¿ 1725056
    Product Code
    DWJ
    UDI-DI
    00801741080159
    PMA / PMN Number
    K161602
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED ISSUE WAS CONFIRMED. THE ROOT CAUSE OF THE REPORTED ISSUE IS DUE TO A FAILED FLOW METER. CIRCULATING PUMP PULSE WIDTH MODULATION (PWM) 210 OR GREATER DURING PRESSURE GAIN SETTING. PWM = 210. FLOW METER WAS REPLACED. DURING THE REIMAGING OF GRAPHICS SOFTWARE, A DISK ERROR OCCURRED. CONTROL PANEL WAS REPLACED. THE CONDENSER COIL WAS CLEANED. THE UNIT PASSED ALL TESTS, IS FUNCTIONING PROPERLY AND IS READY FOR USE. THE DEVICE DID NOT MEET SPECIFICATIONS, AND WAS INFLUENCED BY THE REPORTED FAILURE. THE DEVICE WAS NOT IN USE ON A PATIENT. A DHR IS NOT REQUIRED AS THIS IS NOT AN OUT-OF-BOX FAILURE AND THEREFORE IS NOT MANUFACTURING RELATED. THE COMPLAINT OR REPORTED ISSUE WAS CONFIRMED THROUGH OTHER ELEMENTS OF THE INVESTIGATION TO NOT BE LABELING OR PACKAGING RELATED. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF 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 BARD. H3 OTHER TEXT : THE ACTUAL/SUSPECTED DEVICE WAS EVALUATED.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ARCTIC SUN DEVICE RECEIVED AN ERROR 37 (WATER TEMPERATURE HIGH), CIRCULATION PUMP PULSE WIDTH MODULATION (PWM) WAS 210 OR GREATER DURING PRESSURE GAIN SETTING AND PULSE WIDTH MODULATION (PWM) WAS 210. THIS WAS OCCURRED DURING AUTOMATED CALIBRATION AND TEST SYSTEM (ACATS) AND FLOW METER WAS REPLACED. DURING THE REIMAGING OF GRAPHICS SOFTWARE, A DISK ERROR OCCURRED AND A NEW CONTROL PANEL FROM LOANER POOL WAS INSTALLED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ARCTIC SUN DEVICE RECEIVED AN ERROR 37 (WATER TEMPERATURE HIGH), CIRCULATION PUMP PULSE WIDTH MODULATION (PWM) WAS 210 OR GREATER DURING PRESSURE GAIN SETTING AND PULSE WIDTH MODULATION (PWM) WAS 210. THIS WAS OCCURRED DURING AUTOMATED CALIBRATION AND TEST SYSTEM (ACATS) AND FLOW METER WAS REPLACED. DURING THE REIMAGING OF GRAPHICS SOFTWARE, A DISK ERROR OCCURRED AND A NEW CONTROL PANEL FROM LOANER POOL WAS INSTALLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2330601 ARCTIC SUN® 5000 ARCTIC SUN DEVICE DWJ MEDIVANCE, INC. ¿ 1725056 50000000L NA 00801741080159

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other