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

Catalog Number	60000000L
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2025
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: 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 the nurse stated they started cooling a patient about an hour and a half ago.The targeted temperature (tt) was 36c.The patient cooled below the target and was currently 34.9c.S/n (b)(6).Confirmed water temperature was 38.5c and water flow rate (wfr) was 3.4 l/min.Nurse stated they had medium pads on the patient with good skin coverage.Explained the device was making extremely warm water and appears to be responding appropriately.Patient was fully sedated and was not shivering, no signs of heat generation.Nurse stated when they initiated therapy, the patient was not fully sedated.Explained the device may have recognized heat generation if the patient was moving or shivering which can lead to overshoot.Water temperature was up to 40c.Suggested nurse consult their protocol for counter warming such as warm blankets, bair hugger, vent warmer etc.To help increase the patient's temperature.Also discussed with prolonged warm water exposure, they may increase their skin checks frequency.Encouraged nurse to call back with any questions or issues.
Event or Problem Description
It was reported that the nurse stated they started cooling a patient about an hour and a half ago.The targeted temperature (tt) was 36c.The patient cooled below the target and was currently 34.9c.S/n (b)(6).Confirmed water temperature was 38.5c and water flow rate (wfr) was 3.4 l/min.Nurse stated they had medium pads on the patient with good skin coverage.Explained the device was making extremely warm water and appears to be responding appropriately.Patient was fully sedated and was not shivering, no signs of heat generation.Nurse stated when they initiated therapy, the patient was not fully sedated.Explained the device may have recognized heat generation if the patient was moving or shivering which can lead to overshoot.Water temperature was up to 40c.Suggested nurse consult their protocol for counter warming such as warm blankets, bair hugger, vent warmer etc.To help increase the patient's temperature.Also discussed with prolonged warm water exposure, they may increase their skin checks frequency.Encouraged nurse to call back with any questions or issues.
Additional Manufacturer Narrative
The reported issue was inconclusive.The root cause for the reported event could not be determined.Confirmed water temperature was 38.5c and water flow rate (wfr) was 3.4 l/min.Nurse stated they had medium pads on the patient with good skin coverage.Explained the device was making extremely warm water and appears to be responding appropriately.Patient was fully sedated and was not shivering, no signs of heat generation.Nurse stated when they initiated therapy, the patient was not fully sedated.Explained the device may have recognized heat generation if the patient was moving or shivering which can lead to overshoot.Water temperature was up to 40c.Suggested nurse consult their protocol for counter warming such as warm blankets, bair hugger, vent warmer etc.To help increase the patient's temperature.Also discussed with prolonged warm water exposure, they may increase their skin checks frequency.Encouraged nurse to call back with any questions or issues.The complaint or reported issue was confirmed through other elements of the investigation to not be manufacturing related.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.Correction: d.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: 23720474
• Report Number: 1018233-2025-10783
• Device Sequence Number: 10209465
• Product Code: DWJ
• UDI-Device Identifier: 00801741161520
• UDI-Public: (01)00801741161520(11)200514
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 01/27/2026

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 01/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/14/2020
• 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