MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® 5000; ARCTIC SUN DEVICE

Catalog Number	50000000L
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that per preventive maintenance, when power on the arctic sun device an unexpected chirping sound was heard.Due to an unexpected chirping sound, pump head will be replaced.Per sample evaluation results on 26dec2024, circulation pump motor failed.
Additional Manufacturer Narrative
The reported issue was confirmed.The root cause identified is a failed circulation pump head.The device was evaluated upon receipt.When powering on the device and set the water target temperature to 40°c ran about 2 minutes and heard an unexpected chirping sound.Replaced circulation pump head.Circulation pump motor failed.Replaced circulation pump motor.Replaced coin cell due to age.The arctic sun passed functionality testing in compliance with manufacturer specifications, functions normally and is ready for use.The complaint or reported issue was confirmed through other elements of the investigation to not be labeling or packaging related.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.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® 5000
• 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 80027
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 21423941
• Report Number: 1018233-2025-01120
• Device Sequence Number: 8189562
• Product Code: DWJ
• UDI-Device Identifier: 00801741080159
• UDI-Public: (01)00801741080159(11)160825
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 02/19/2025

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 Catalogue Number: 50000000L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2016
• 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