MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, TEMPERATURE CABLE

Catalog Number	735-02
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Full initial reporter phone number: (b)(6).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 there was low flow in an arctic sun device.Per review of wo on 05aug2025, there was no patient involvement.Per sample evaluation results received via task on 19aug2025, it was reported that the temperature in cable-nellcor was damaged.
Event or Problem Description
It was reported that there was low flow in an arctic sun device.Per review of wo on 05aug2025, there was no patient involvement.Per sample evaluation results received via task on 19aug2025, it was reported that the temperature in cable-nellcor was damaged.Per sample evaluation results received via task on 18nov2025, it was reported that they noted the heater and mixing pump) have also malfunctioned.
Additional Manufacturer Narrative
The reported issue was confirmed.The root cause of the reported issue could not be determined.During evaluation, it was confirmed that the temperature in cable was damaged.Temperature in cable was replaced.Product testing is complete and confirms the product meets servicing requirements.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.A dhr is not required as the serial number is unknown.Based on the results of the investigation, no additional actions can be taken.Correction: d, h.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.

• Brand Name: ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, TEMPERATURE CABLE
• Common Device Name: TEMPERATURE CABLE
• 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: 22893662
• Report Number: 1018233-2025-07039
• Device Sequence Number: 20330158
• Product Code: DWJ
• UDI-Device Identifier: 00801741080296
• UDI-Public: (01)00801741080296
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 12/19/2025

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: 735-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2025
• Supplement Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 08/26/2025
• Supplement Report FDA Received Date: 01/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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