MAUDE Adverse Event Report: MEDIVANCE -1725056 ARCTIC SUN® 5000A; ARCTIC SUN DEVICE

Catalog Number	50000000E
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the arctic sun device issued a red screen upon startup and a message to reboot the device.Per review of wo notes, biomed will check the connection between control panel and processor cards and call back if the issue remains.Biomed called back and walked them through checking the communication connector and they said they had already reseated the circuit boards and issue was still occurring, they explained it would need to come in to get the root cause figured out because it could be one of multiple parts, they asked what parts and hung up after they went over the parts, they declined the quote.Per additional information received via ttm on 16mar2026, nurse stated they were getting a red screen with message.System failed to start.Power down then powers up to retry.Contact medivance.Nurse confirmed they have already tried rebooting a couple of times and the message kept returning.Advised to send to biomed so that they could call back and speak with engineers for additional support.Per sample evaluation results on 12may2026, power circuit card contributed to the reported issue.
Additional Manufacturer Narrative
The reported issue was confirmed.The root cause of the reported issue is due to a failed isolation circuit card.Red screen was seen during decontamination.Isolation circuit card was replaced.Power circuit card contributed to the reported issue.Power circuit card was replaced.The control panel coin cell was replaced due to age.The arctic sun 5000 passed all performance testing, calibration and electrical safety tests and is functioning properly and ready for use.A dhr review is not required as the reported event is not an out of box failure and therefore the reported event is not manufacturing related.The complaint or reported issue was confirmed through other elements of the investigation to not be labeling or packaging related.Based on the results of the investigation, no additional actions can be taken.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® 5000A
• 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: 25392315
• Report Number: 1018233-2026-03609
• Device Sequence Number: 10671840
• Product Code: DWJ
• UDI-Device Identifier: 00801741127755
• UDI-Public: (01)00801741127755
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K161602
• 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
• Report Date (Section B): 05/28/2026

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: 50000000E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2026
• Initial Report FDA Received Date: 06/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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