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

Catalog Number	317-05-02
Medical Device Problem Code	Inaccurate Flow Rate (1249)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2025
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: 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 a low flow alarm on arctic sun device s/n (b)(6).They filled the reservoir, but that did not resolve the issue.Flow rate (fr) was 0lpm, inlet pressure (ip) was -0psi, circulation pump command (cpc) was 0%.Pump hours were 388, system hours were 578.Small pads in use.Stopped therapy.Disconnected and reconnected the pads using proper technique.Flow rate was 1pm, inlet pressure (ip) was -0.7psi, circulation pump command (cpc) was 100%.Stopped therapy.Disconnected pads.Started device in manual mode.Flow rate was 1.8lpm, inlet pressure (ip) was -7.1psi, circulation pump command (cpc) was 48%.Connected pads (lot ngjv0901) one at a time.Left thigh inlet pressure (ip) was -0.7psi.Disconnected left thigh.Connected left chest flow rate was 0.9lpm, inlet pressure (ip) was -7psi, circulation pump command (cpc) was 31%.Right chest floe rate was 2.1lpm, inlet pressure was-7.2psi, circulation pump command (cpc) was 51%.Right thigh flow rate 2.8lpm, inlet pressure was-7.2psi, circulation pump command (cpc) was 65%.Placed device back in automatic mode.Suggested replacing the left thigh with a universal pad.Asked to place left thigh pad behind the nursing station for quality.

• 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: 23387948
• Report Number: 1018233-2025-09568
• Device Sequence Number: 12941091
• Product Code: DWJ
• UDI-Device Identifier: 00801741080067
• UDI-Public: (01)00801741080067(11)241029(17)260731(10)NGJV0901
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 04/29/2026

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 Expiration Date: 07/31/2026
• Device Catalogue Number: 317-05-02
• Device Lot Number: NGJV0901
• 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: 10/19/2025
• Supplement Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 10/26/2025
• Supplement Report FDA Received Date: 05/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/29/2024
• 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