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

Catalog Number	735-02
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2025
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: 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 fss stated that they had the arctic sun device with a bad temperature cable 735-02, gave part number and price for a new one.
Additional Manufacturer Narrative
The reported issue was inconclusive.The root cause for the reported event could not be determined.Gave part number and price for a new one.Per follow up information received via task on 02apr2025, per review of event and work order, bd representative successfully troubleshot the malfunction during the call.The event concluded with the device successfully troubleshot with technical support and appropriate repair has been discussed.No patient involved.A dhr review is not required as the lot number is unknown.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.Corrections b, e, f, 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 fss stated that they had the arctic sun device with a bad temperature cable 735-02, gave part number and price for a new one.Per follow up information received via task on 02apr2025, per review of event and work order, bd representative successfully troubleshot the malfunction during the call.The event concluded with the device successfully troubleshot with technical support and appropriate repair has been discussed.No patient involved.

• Brand Name: ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, TEMPERATURE CABLE NELLCOR
• Common Device Name: ARCTIC SUN 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: 21459973
• Report Number: 1018233-2025-01252
• Device Sequence Number: 12726355
• Product Code: DWJ
• UDI-Device Identifier: 00801741080296
• UDI-Public: (01)00801741080296
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• 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): 07/16/2025

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2025
• Supplement Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 02/25/2025
• Supplement Report FDA Received Date: 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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