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

Catalog Number	50000000L
Medical Device Problem Code	Circuit Failure (1089)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that they were getting an alarm on arctic sun device s/n (b)(6) that reads inlet water temperature sensor out of range - high resistance.Patient temperature (pt) was 95f, targeted temperature (tt) was 97f, water temperature (wt) was 23.9f, flow rate (fr) was 0lpm.Asked nurse to try to resume therapy after cycling the power and the alarm comes back.Confirmed alarm 75 from event log.Advised to send device to biomed labeled with alarm 75.Per follow up information received via phone on 06feb2026, spoke with nurse who confirmed the patient was put on a new device and therapy resumed without issue.There was no change in pads.Stated the alarm from the first device would stop therapy so they could not get a flow rate or therapy to run at all.They denied any issues with flow.The device had been retrieved from the hall yesterday.
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.
Additional Manufacturer Narrative
The reported issue was inconclusive.The root cause for the reported event could not be determined.Patient temperature (pt) was 95f, targeted temperature (tt) was 97f, water temperature (wt) was 23.9f, flow rate (fr) was 0lpm.Asked nurse to try to resume therapy after cycling the power and the alarm comes back.Confirmed alarm 75 from event log.Advised to send device to biomed labeled with alarm 75.Per follow up information received via phone on 06feb2026, spoke with nurse who confirmed the patient was put on a new device and therapy resumed without issue.There was no change in pads.Stated the alarm from the first device would stop therapy so they could not get a flow rate or therapy to run at all.They denied any issues with flow.The device had been retrieved from the hall yesterday.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.
Event or Problem Description
It was reported that they were getting an alarm on arctic sun device sn (b)(6) that reads inlet water temperature sensor out of range, high resistance.Patient temperature (pt) was 95f, targeted temperature (tt) was 97f, water temperature (wt) was 23.9f, flow rate (fr) was 0lpm.Asked nurse to try to resume therapy after cycling the power and the alarm comes back.Confirmed alarm 75 from event log.Advised to send device to biomed labeled with alarm 75.Per follow up information received via phone on 06feb2026, spoke with nurse who confirmed the patient was put on a new device and therapy resumed without issue.There was no change in pads.Stated the alarm from the first device would stop therapy so they could not get a flow rate or therapy to run at all.They denied any issues with flow.The device had been retrieved from the hall yesterday.

• 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: 24383221
• Report Number: 1018233-2026-00960
• Device Sequence Number: 10278828
• Product Code: DWJ
• UDI-Device Identifier: 00801741080159
• UDI-Public: (01)00801741080159(11)160701
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 03/25/2026

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: 50000000L
• 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: 02/05/2026
• Supplement Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 02/18/2026
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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