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

Catalog Number	50000000L
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported issue was confirmed.The root cause identified as a flow meter failure.The device was evaluated upon receipt.It was confirmed that the unit had low flow in bypass.Flow meter was replaced.The arctic sun 5000 was functionally tested (heats above 30°c and cools below 6°c and is stable at 28°c with a flow of 1.8 l/m with -7.0 psi in bypass mode), and electrical safety tested.The unit passed all tests, is functioning properly and is ready for use.In the event that information regarding the outcome of the repair and the status of the device is received, this record will be reopened to update the investigation.See the attached investigation closure memo for more information.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 device has undergone previous servicing and therefore the reported issue is not manufacturing related.All available udi information is being provided.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 per wo, there was a crack in the bottom left side of the bezel in an arctic sun device.The processor circuit card screw, loop strap and wing nut are missing.During pre-calibration the unit had low flow in bypass, so the flow meter was replaced.
Event or Problem Description
It was reported that per wo, there was a crack in the bottom left side of the bezel in an arctic sun device.The processor circuit card screw, loop strap and wing nut are missing.During pre-calibration the unit had low flow in bypass, so the flow meter was replaced.
Additional Manufacturer Narrative
Upon further review, bd has determined that this mdr is not reportable.Submitting the investigation details as additional information.The reported issue was confirmed.The root cause identified as a flow meter failure.The device was evaluated upon receipt.It was confirmed that the unit had low flow in bypass.Flow meter was replaced.The arctic sun 5000 was functionally tested (heats above 30°c and cools below 6°c and is stable at 28°c with a flow of 1.8 l/m with -7.0 psi in bypass mode), and electrical safety tested.The unit passed all tests, is functioning properly 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 device has undergone previous servicing and therefore the reported issue is not manufacturing related.No additional actions are needed.Correction: 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® 5000
• 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: 23525810
• Report Number: 1018233-2025-10167
• Device Sequence Number: 10202338
• Product Code: DWJ
• UDI-Device Identifier: 00801741080159
• UDI-Public: (01)00801741080159(11)160701
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 12/09/2025

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: 02/26/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2025
• Supplement Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 11/11/2025
• Supplement Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2016
• 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