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

Catalog Number	735-56
Medical Device Problem Codes	Failure to Sense (1559); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2025
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.Initial reporter phone: (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.
Event or Problem Description
It was reported that the patient temperature was not displayed on the patient monitor connected to arctic sun device stat.Per review of wo on 10sep2025, there was no patient involvement.
Event or Problem Description
It was reported that the patient temperature was not displayed on the patient monitor connected to arctic sun device stat.Per review of wo on 10sep2025, there was no patient involvement.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Correction: d, f, g, h.Initial reporter phone: (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 issue was confirmed.The root cause of the reported issue is a failed temperature out cable.The complaint or reported issue was confirmed through other elements of the investigation to not be labeling or packaging related.A dhr review is not required as the lot number is unknown.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 patient temperature was not displayed on the patient monitor connected to arctic sun device stat.Per review of wo on 10sep2025, there was no patient involvement.

• Brand Name: ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, TEMPERATURE OUT CABLE PHILIPS
• Common Device Name: ARCTIC SUN® TEMPERATURE OUT CABLE PHILIPS
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville 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: 23038493
• Report Number: 1018233-2025-08028
• Device Sequence Number: 13282476
• Product Code: DWJ
• UDI-Device Identifier: 00801741080388
• UDI-Public: (01)00801741080388
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Followup
• Report Date (Section B): 01/07/2026

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 Catalogue Number: 735-56
• 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: 09/08/2025
• Supplement Date Received by Manufacturer: 01/05/2026; 01/07/2026
• Initial Report FDA Received Date: 09/12/2025
• Supplement Report FDA Received Date: 01/06/2026; 01/08/2026
• 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