MAUDE Adverse Event Report: MEDIVANCE -1725056 ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS; ARCTIC GEL PADS

Catalog Number	317-07-02
Medical Device Problem Code	Inaccurate Flow Rate (1249)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2026
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 was trying to start therapy, but device primed and stopped.Disconnected and reconnected pads using proper technique and restarted therapy in an arctic sun device.Guided to diagnostics showed that the system hours were 945, pump hours were 853, inlet pressure (ip) was -1.3psi, circulation pump command (cpc) was 100 percentage, flow rate (fr) was 0lpm, primed then stopped.Stopped therapy, drained and disconnected pads and placed device in manual control, no pads attached inlet pressure (ip) was -6.9psi, circulation pump command (cpc) was 47 percentage, flow rate (fr) was 1.7lpm.Someone came in with a new device at this time (b)(6).Tried to start therapy one more time on the first device, but it primed and stopped again.Moved pads and probe to new device.Device did not stop, but flow rate (fr) was only 0.2lpm.Guided to diagnostics showed that the system hours were 1109, pump hours were 1091, inlet pressure (ip) was -1.5psi, circulation pump command (cpc) was 100 percentage, flow rate (fr) was 0.2lpm.They would change pads at this time and call back if they continue to have issues.Pad lot ngkx3637.Advised they should hold onto these pads for investigation.Per follow up information received via task on 01apr2026, spoke with charge nurse who confirmed retention of the pads.

• Brand Name: ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS
• Common Device Name: ARCTIC GEL PADS
• 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: 24801210
• Report Number: 1018233-2026-02272
• Device Sequence Number: 13431717
• Product Code: DWJ
• UDI-Device Identifier: 00801741080081
• UDI-Public: (01)00801741080081(11)251122(17)270930(10)NGKX3637
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K142702
• 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): 05/15/2026

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: 317-07-02
• Device Lot Number: NGKX3637
• 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: 03/31/2026
• Supplement Date Received by Manufacturer: 05/15/2026
• Initial Report FDA Received Date: 04/07/2026
• Supplement Report FDA Received Date: 05/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/22/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown