MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS; ARCTICGEL PADS

Catalog Number	317-05-02
Medical Device Problem Code	Inaccurate Flow Rate (1249)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is still in progress.Once the investigation is complete a supplemental report will be filed.All available udi information is being provided.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.
Event or Problem Description
A slow flow rate issue occured when operating the equipment for ttm.
Additional Manufacturer Narrative
The reported issue was inconclusive.The root cause of the reported issue could not be identified.Visual inspection noted the following: 1.One photo shows a small right chest pad sticker with lot number ngjr09452.One returned photo shows one or more chest pads in a bag with a note about low flow issues.The hydrogel layer appears to be absent from the surface of a pad.(b)(4) was opened to capture this finding.3.No conclusions can be drawn regarding the reported low flow issue from the returned photos as they do not clearly show the flow path of any pad.The labeling is found to be adequate.Per the ifu: 5.Attach the pad¿s line connectors to the patient line manifolds.Begin circulating water through the pads using either patient temperature control mode (automatic) or water temperature control mode (manual).If the pads fail to prime or a significant continuous air leak is observed in the pad return line, check connections, then if needed replace the leaking pad.6.Once the pads are primed, assure the flow rate displayed on the control panel is greater than 1.7 liters per minute, which is the minimum flow rate for a full pad kit (4)." a review of the device history record and manufacturing controls did not show any problems or conditions that would have contributed to the reported issue.Therefore, no additional action is required at this time.Correction: d,e,h.Udi format updated with available product information per gudid.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.
Event or Problem Description
A slow flow rate issue occured when operating the equipment for ttm.Per follow up information received via task on 18sep2025, the number of quantities affected was 1 and attached a photo of the arctic gel pad sample with the pad information for (b)(4).Per sample evaluation results received via task on 15jan2026, it was reported that the in the photo returned by the customer, the hydrogel layer appears to be absent from the pad surface.

• Brand Name: ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS
• Common Device Name: ARCTICGEL PADS
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville 80027
• Manufacturer (Section G): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville 80027
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 23071058
• Report Number: 1018233-2025-08199
• Device Sequence Number: 4966303
• Product Code: DWJ
• UDI-Device Identifier: 00801741080067
• UDI-Public: (01)00801741080067(11)240617(17)260331(10)NGJR0945
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K142702
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2026

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 Expiration Date: 03/31/2026
• Device Catalogue Number: 317-05-02
• Device Lot Number: NGJR0945
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2025
• Supplement Date Received by Manufacturer: 04/03/2026
• Initial Report FDA Received Date: 09/17/2025
• Supplement Report FDA Received Date: 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2024
• 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