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

Catalog Number	733-00
Medical Device Problem Code	Circuit Failure (1089)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2025
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: 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 screen stayed black in an arctic sun device.Per review of wo on (b)(6) 2025, there was no patient involvement.Per follow up information received via task on 12mar2025, the device would be sent to task management for repair.Device has not been serviced yet.Per sample evaluation results received via task on 25mar2025, it was reported that there was an electrical safety test failed.
Additional Manufacturer Narrative
The reported issue was confirmed.The root cause of the reported issue is a failed power cord.The device was evaluated upon receipt.Electrical safety test failed due a too high earth bont value 480 ohm.Replaced the power cord.This solved this problem and electrical safety test passed without problems.Device passed functional test, calibration, and electrical safety test.A dhr review is not required as the serial number is unknown.The complaint or reported issue was confirmed through other elements of the investigation to not be labeling or packaging related.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.
Event or Problem Description
It was reported that the screen stayed black in an arctic sun device.Per review of wo on 07mar2025, there was no patient involvement.Per follow up information received via task on 12mar2025, the device would be sent to task management for repair.Device has not been serviced yet.Per sample evaluation results received via task on 25mar2025, it was reported that there was an electrical safety test failed.

• Brand Name: ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, POWER CORD
• Common Device Name: POWER CORD
• 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 CO 80027
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 21709691
• Report Number: 1018233-2025-02087
• Device Sequence Number: 18644580
• Product Code: DWJ
• UDI-Device Identifier: 00801741080258
• UDI-Public: (01)00801741080258
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 04/01/2025

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: 733-00
• 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: 03/25/2025
• Supplement Date Received by Manufacturer: 04/01/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 04/02/2025
• 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