BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCTIC SUN® 5000

    MDR report key: 11986329 · Received June 11, 2021

    Report

    Report Number
    1018233-2021-03442
    Event Type
    Malfunction
    Date Received
    June 11, 2021
    Date of Event
    May 18, 2021
    Report Date
    November 19, 2021
    Manufacturer
    MEDIVANCE, INC. ¿ 1725056
    Product Code
    DWJ
    UDI-DI
    00801741080142
    PMA / PMN Number
    K161602
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED ISSUE WAS UNCONFIRMED. THE ROOT CAUSE FOR THE REPORTED ISSUE COULD NOT BE DETERMINED AS THE DEVICE RESUMED NORMAL FUNCTIONING. BIOMED WANTED TO GET REPAIR AND LOANER PRICING. MSS TRANSFERRED CALL TO TECHNICAL SUPPORT FOR ASSISTANCE. PER FOLLOW UP, WHILE ON THE PHONE WITH TECHNICAL SUPPORT, BIOMED STATED THAT THE PUMP BEGAN FUNCTIONING CORRECTLY AGAIN AND THE ISSUE WAS RESOLVED. IT IS UNKNOWN WHETHER THE DEVICE WAS INFLUENCED BY THE REPORTED FAILURE, HOWEVER THE DEVICE MET SPECIFICATIONS. THE DEVICE WAS NOT IN USE ON A PATIENT. THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE REPORTED EVENT IS UNCONFIRMED, DHR REVIEW IS NOT REQUIRED. THE REPORTED EVENT IS UNCONFIRMED THE RISK REVIEW AND LABELING/PACKAGING REVIEW IS NOT REQUIRED. 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 DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ARCTIC SUN DEVICE HAD A FAILED CIRCULATION PUMP. BIOMED WANTED TO GET REPAIR AND LOANER PRICING. MSS TRANSFERRED CALL TO TECHNICAL SUPPORT FOR ASSISTANCE. PER FOLLOW UP VIA PHONE 20MAY2021, WHILE ON THE PHONE WITH TECHNICAL SUPPORT, BIOMED STATED THAT THE PUMP BEGAN FUNCTIONING CORRECTLY AGAIN AND THE ISSUE WAS RESOLVED. THERE WAS NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ARCTIC SUN DEVICE HAD A FAILED CIRCULATION PUMP. BIOMED WANTED TO GET REPAIR AND LOANER PRICING. MSS TRANSFERRED CALL TO TECHNICAL SUPPORT FOR ASSISTANCE. PER FOLLOW UP VIA PHONE (B)(6) 2021, WHILE ON THE PHONE WITH TECHNICAL SUPPORT, BIOMED STATED THAT THE PUMP BEGAN FUNCTIONING CORRECTLY AGAIN AND THE ISSUE WAS RESOLVED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    880088 ARCTIC SUN® 5000 ARCTIC SUN DEVICE DWJ MEDIVANCE, INC. ¿ 1725056 50000000 NA 00801741080142

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other