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

Catalog Number	317-03-02
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.The complete initial reporter facility name is yangsan pusan national university hospital 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
It was reported that alarm 01 (patient line open) occurred that the arctic sun gel pad line was exposed to the air, so after checking with service, customer replaced the arctic sun gel pad.
Event or Problem Description
It was reported that alarm 01 (patient line open) occurred that the arctic sun gel pad line was exposed to the air, so after checking with service, customer replaced the arctic sun gel pad.Per follow up information received via mail on 10jan2025, device will send to gimpo warehouse.Asked the service team and suspected there was a problem with the gel pad, so representative replaced it with a new gel pad.Replace with new gel pad and inspect equipment during service.Lot number nghx0414 provided.There was no harm to the patient.Per sample evaluation results on (b)(6) 2025, the ends of all connectors were visibly deformed.The right chest pad was missing a large patch of hydrogel from the middle of the pad.
Additional Manufacturer Narrative
The reported issue was confirmed.The root cause of the reported issue is kinking in the pad lines.Visual evaluation of the returned sample noted one opened extra small arctic gel pad kit present with no original packaging.Two photo samples were also received for evaluation.Visual inspection noted the following: -no obvious visible defects such as cuts or tears in the foam.-the ends of all connectors were visibly deformed.Additionally, the left thigh pad connector was chipped, causing difficulty in connecting.A record was opened to capture this failure.-major kinking was present in the right thigh and left chest pad tubing that affected flow rate.Tubing for all other pads noted no kinks present.-the right chest pad was missing a large patch of hydrogel from the middle of the pad.A record was opened to capture this failure.Hydrogel was intact with pad and not separated on all other pads.-no crushed dimples or signs of over lamination in the pads.-one returned photo shows an arctic sun model 5000 screen with alert 01.The flow rate shown onscreen is 0.0 l/m.-one returned photo shows a sticker for an extra small right chest pad, lot number nghx0414.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.The complaint or reported issue was confirmed through other elements of the investigation to not be labeling or packaging related.Corrections: d, e, f, 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.

• 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, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville 80027
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 21054392
• Report Number: 1018233-2024-08452
• Device Sequence Number: 20871456
• Product Code: DWJ
• UDI-Device Identifier: 10801741080040
• UDI-Public: (01)10801741080040(11)231026(17)250930(10)NGHX0414
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2025

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: 09/30/2025
• Device Catalogue Number: 317-03-02
• Device Lot Number: NGHX0414
• 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: 12/27/2024
• Supplement Date Received by Manufacturer: 04/21/2025
• Initial Report FDA Received Date: 01/02/2025
• Supplement Report FDA Received Date: 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2023
• 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