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

Catalog Number	317-09-02
Medical Device Problem Code	Inaccurate Flow Rate (1249)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that they were trying to initiate therapy using arctic sun device s/n: (b)(6) but cannot get the pads to prime.Also, there were no blue and white stickers on the connectors.Flow 0lpm, inlet pressure (ip) was -0.2psi, circulation pump command (cpc) was 100%.Pump hours 3200.System hours 3500.Explained the pads were redesigned and no longer contain the blue and white stickers.The pads can now connect in either orientation.Stopped therapy, disconnected pads and started manual control.Flow 2lpm, inlet pressure (ip) was -7.0psi, circulation pump command (cpc) was 64%.Connected pads one at a time.Right thigh 0.9lpm, -7.0psi, circulation pump command (cpc) was 42%.Left thigh flow 2lpm, inlet pressure (ip) was -7.0psi, circulation pump command (cpc) was 50%.Right chest flow 2lpm, inlet pressure (ip) was -7.0psi, circulation pump command (cpc) was69%.Left chest flow 0lpm, inlet pressure (ip) was -0.2psi, circulation pump command (cpc) was 100%.Flow did not improve when the left chest pad was moved to another valve set.Lot#: ngjx2433.Removed left chest pad and resumed therapy in automatic mode.Flow rate was 1.6lpm.Suggested placing a universal pad or two on the patient's left chest for adequate pad coverage.
Additional Manufacturer Narrative
Investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The initial reporter facility name is (b)(6).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.
Additional Manufacturer Narrative
The reported event was inconclusive because this investigation did not result in any additional findings and no sample was available for evaluation a review of the device history record did not show any problems or conditions that would have contributed to the reported issue.Initial reporter complete facility name: (b)(6).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 they were trying to initiate therapy using arctic sun device s/n (b)(6) but cannot get the pads to prime.Also, there were no blue and white stickers on the connectors.Flow 0lpm, inlet pressure (ip) was -0.2psi, circulation pump command (cpc) was 100%.Pump hours 3200.System hours 3500.Explained the pads were redesigned and no longer contain the blue and white stickers.The pads can now connect in either orientation.Stopped therapy, disconnected pads and started manual control.Flow 2lpm, inlet pressure (ip) was -7.0psi, circulation pump command (cpc) was 64%.Connected pads one at a time.Right thigh 0.9lpm, -7.0psi, circulation pump command (cpc) was 42%.Left thigh flow 2lpm, inlet pressure (ip) was -7.0psi, circulation pump command (cpc) was 50%.Right chest flow 2lpm, inlet pressure (ip) was -7.0psi, circulation pump command (cpc) was69%.Left chest flow 0lpm, inlet pressure (ip) was -0.2psi, circulation pump command (cpc) was 100%.Flow did not improve when the left chest pad was moved to another valve set.Lot# ngjx2433.Removed left chest pad and resumed therapy in automatic mode.Flow rate was 1.6lpm.Suggested placing a universal pad or two on the patient's left chest for adequate pad coverage.

• Brand Name: ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS
• Common Device Name: ARCTIC GEL PADS
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville 80027
• Manufacturer (Section G): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville 80027
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 23134498
• Report Number: 1018233-2025-08531
• Device Sequence Number: 9857671
• Product Code: DWJ
• UDI-Device Identifier: 00801741080104
• UDI-Public: (01)00801741080104(11)250115(17)260930
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 04/22/2026

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: 09/30/2026
• Device Catalogue Number: 317-09-02
• Device Lot Number: NGJX2433
• 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: 09/21/2025
• Supplement Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 09/24/2025
• Supplement Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/15/2025
• 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