MAUDE Adverse Event Report: MEDIVANCE -1725056 Arctic Sun® Temperature Management System, ArcticGel¿ Pads; Arctic Gel Pads

Catalog Number	317-05-02
Medical Device Problem Codes	Inaccurate Flow Rate (1249); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.Udi format updated with available product information per gudid.H11: sections 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.
Event or Problem Description
It was reported that the flow rate could not increase, preliminary assessment indicates a patch air leak.Replacing one set of arctic gel pad should resolve the issue, water leakage.The incident occurred during use.Per follow up information received via task on 02feb2026, the number of products affected was one.No impact to the patient.

• Brand Name: Arctic Sun® Temperature Management System, ArcticGel¿ Pads
• Common Device Name: Arctic Gel Pads
• Manufacturer (Section D): MEDIVANCE -1725056; 321 south taylor ave; suite 200; louisville CO 80027
• Manufacturer (Section G): MEDIVANCE -1725056; 321 south taylor ave; suite 200; louisville CO 80027
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; +1(770)784-6100
• MDR Report Key: 24268772
• Report Number: 1018233-2026-00654
• Device Sequence Number: 10669373
• Product Code: DWJ
• UDI-Device Identifier: 00801741080067
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K142702
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 317-05-02
• Device Lot Number: NGKU3889
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/12/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2026
• Supplement Date Received by Manufacturer: 07/23/2026
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown