MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 Arctic Sun Stat; Arctic Sun Device

Catalog Number	60000000
Medical Device Problem Code	Insufficient Heating (1287)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the biomed stated the arctic sun device was not warming the patient.
Event or Problem Description
It was reported that the biomed stated the arctic sun device was not warming the patient.
Additional Manufacturer Narrative
The reported issue was confirmed.The root cause for the reported event could not be determined.The repairs for the reported event are currently unknown but will be updated if more information is provided.Review of the dhr did not indicate any manufacturing nonconformance that could have caused and or contributed to the reported event.The instructions for use are found to be adequate.The ifu currently instructs the user on the proper method to use this device to avoid undue injury to the patient and damage to the product.Based on the results of the investigation, no additional actions are needed.Corrections: b, d, f, h 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.
Additional Manufacturer Narrative
The device was not returned.Reported issue: it was reported that the biomed stated the arctic sun device was not warming the patient.Reported issue root cause: the root cause for the reported event could not be determined.Repairs related to the reported issue: the repairs for the reported event are currently unknown but will be updated if more information is provided.The reported issue was confirmed.The root cause for the reported event could not be determined.The repairs for the reported event are currently unknown but will be updated if more information is provided.Review of the dhr did not indicate any manufacturing nonconformance that could have caused and/or contributed to the reported event.The instructions for use are found to be adequate.The ifu currently instructs the user on the proper method to use this device to avoid undue injury to the patient and damage to the product.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 Stat
• Common Device Name: Arctic Sun Device
• 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 CO 80027
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; +1(770)784-6100
• MDR Report Key: 50739295
• Report Number: 1018233-2026-05884
• Device Sequence Number: 13397470
• Product Code: DWJ
• UDI-Device Identifier: 00801741161513
• UDI-Public: (01)00801741161513(11)260729
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K200225
• 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): 09/18/2026

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: 60000000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2026
• Supplement Date Received by Manufacturer: 09/15/2026; 09/18/2026
• Initial Report FDA Received Date: 09/11/2026
• Supplement Report FDA Received Date: 09/17/2026; 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/29/2026
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown