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

Catalog Number	317-03
Medical Device Problem Codes	Fitting Problem (2183); Defective Component (2292)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the gel pad could not be connected to the main unit on the arctic sun device.It was hard and did not fit.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.
Additional Manufacturer Narrative
The reported event is confirmed.The root cause of the reported issue is a damaged pad connector.Visual evaluation of the returned sample noted 1 extra small arctic gel pad kit present with original packaging label.Visual inspection noted the following: * no obvious visible defects such as cuts or tears in the foam.* connectors for the left thigh pad were marked with an "x" and chips were seen on the ends.No visible chips or deformities at the ends of the connectors for all other pads.* tubing for all the pads noted no kinks present.* hydrogel was intact with pad and not separated.* no crushed dimples in the pads.The sample does not meet specifications per inspection procedure, which states "missing or damaged components are not allowed (the plastic film, foam or hydrogel, connector and tubes shall be free of damages, tears or perforations)".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.The instructions for use were found adequate and state the following: "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." 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 the gel pad could not be connected to the main unit on the arctic sun device.It was hard and did not fit.Per follow up information received via (b)(4) on (b)(6) 2024, unknown whether the issue was resolved or not.Patient was involved.Unknown whether the patient complete therapy on the original device.
Additional Manufacturer Narrative
The reported event is confirmed.The root cause of the reported issue is a damaged pad connector.Visual evaluation of the returned sample noted 1 extra small arctic gel pad kit present with original packaging label.Visual inspection noted the following: no obvious visible defects such as cuts or tears in the foam.Connectors for the left thigh pad were marked with an "x" and chips were seen on the ends.No visible chips or deformities at the ends of the connectors for all other pads.Tubing for all the pads noted no kinks present.Hydrogel was intact with pad and not separated.No crushed dimples in the pads.The reported issue could not be verified without further testing.The left thigh pad could not be fully connected to the arctic sun fluid delivery line.The connector could not be pushed for enough into the fluid delivery line to snap into place.All other pads could be connected with water flow observed after connecting.The sample does not meet specifications per inspection procedure, which states "missing or damaged components are not allowed (the plastic film, foam or hydrogel, connector and tubes shall be free of damages, tears or perforations)".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.The instructions for use were found adequate and state the following: "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." 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 the gel pad could not be connected to the main unit on the arctic sun device.It was hard and did not fit.Per follow up information received via ibc on 19feb2024, unknown whether the issue was resolved or not.Patient was involved.Unknown whether the patient complete therapy on the original device.

• Brand Name: ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS
• Common Device Name: ARCTIC GEL 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 30014 ; 7707846100
• MDR Report Key: 18194236
• Report Number: 1018233-2023-08460
• Device Sequence Number: 7715368
• Product Code: DWJ
• UDI-Device Identifier: 00801741080043
• UDI-Public: (01)00801741080043(11)230328(17)250228(10)NGHP2414
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K142702
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/02/2024

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: 02/28/2025
• Device Catalogue Number: 317-03
• Device Lot Number: NGHP2414
• 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: 11/07/2023
• Supplement Date Received by Manufacturer: 04/26/2024; 08/02/2024
• Initial Report FDA Received Date: 11/22/2023
• Supplement Report FDA Received Date: 04/26/2024; 08/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2023
• 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