MAUDE Adverse Event Report: MEDIVANCE -1725056 ARCTIC SUN STAT; ARCTIC SUN DEVICE

Catalog Number	60000000L
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2026
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 this loaner arctic sun device boots directly to the normothermia screen and bypasses the patient therapy selection screen.Per additional information updated from ttm on 12jan2026, they have a loaner device, s/n (b)(6).They need to set their protocol settings, but they were not saving when they cycle the power.Attempted to direct caller to the advanced setup tab, but the option was not there even after cycling the power.Biomed was going to take the device to shop and call back to speak with tech support.Biomed calling back for assistance with loaner device that will not allow the account to access the advanced set up.Already tried powering off and back on multiple times.
Event or Problem Description
It was reported that this loaner arctic sun device boots directly to the normothermia screen and bypasses the patient therapy selection screen.Per additional information updated from ttm on 12jan2026, they have a loaner device, sn (b)(6).They need to set their protocol settings, but they were not saving when they cycle the power.Attempted to direct caller to the advanced setup tab, but the option was not there even after cycling the power.Biomed was going to take the device to shop and call back to speak with tech support.Biomed calling back for assistance with loaner device that will not allow the account to access the advanced set up.Already tried powering off and back on multiple times.
Additional Manufacturer Narrative
The reported issue was unconfirmed.The root cause of the reported issue could not be determined, as the device functioned appropriately during evaluation.The device was evaluated upon receipt.No issues.The arctic sun stat is functioning properly.Arctic sun 6000 stat passed all performance testing, and electrical safety tests and is functioning properly and ready for use.A risk review is not required as the reported event is unconfirmed.The labeling/packaging review is not required as the reported event is unconfirmed.A dhr review is not required as the reported event is unconfirmed.Based on the results of the investigation, no additional actions are needed.Corrections: d, 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.

• Brand Name: ARCTIC SUN STAT
• Common Device Name: ARCTIC SUN DEVICE
• 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 ; 7707846100
• MDR Report Key: 24172967
• Report Number: 1018233-2026-00319
• Device Sequence Number: 9649998
• Product Code: DWJ
• UDI-Device Identifier: 00801741161520
• UDI-Public: (01)00801741161520(11)200820
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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
• Report Date (Section B): 03/02/2026

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: 60000000L
• 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: 01/12/2026
• Supplement Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 01/23/2026
• Supplement Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2020
• 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