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

Catalog Number	735-02
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	02/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The reported product number is sold ous.The udi number for this product is not available.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 arctic sun device displayed an error code during operation, image of the console crossed out in red.Today, the device turned on correctly but no longer detects the patient's temperature.Per review of wo on (b)(6) 2025, there was no patient involvement.Per follow up information received via mail on 19feb2025, this would be sent to s-inter for repair.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Correction: d, f, h.Udi format updated with available product information per gudid.H11: sections 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 arctic sun device displayed an error code during operation, image of the console crossed out in red.Today, the device turned on correctly but no longer detects the patient's temperature.Per review of wo on 19feb2025, there was no patient involvement.Per follow up information received via mail on 19feb2025, this would be sent to s-inter for repair.Per sample evaluation results received via task on 14apr2025, it was reported that there was a dirty fill tube.
Event or Problem Description
It was reported that the arctic sun device displayed an error code during operation, image of the console crossed out in red.Today, the device turned on correctly but no longer detects the patient's temperature.Per review of wo on 19feb2025, there was no patient involvement.Per follow up information received via mail on 19feb2025, this would be sent to s-inter for repair.Per sample evaluation results received via task on 14apr2025, it was reported that there was a dirty fill tube.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Corrections: d, e.The reported product number is unknown.The udi number for this product is not available.H11: sections 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 in 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, g, 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 arctic sun device displayed an error code during operation, image of the console crossed out in red.Today, the device turned on correctly but no longer detects the patient's temperature.Per review of wo on 19feb2025, there was no patient involvement.Per follow up information received via mail on 19feb2025, this would be sent to s-inter for repair.Per sample evaluation results received via task on 14apr2025, it was reported that there was a dirty fill tube.

• Brand Name: ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, TEMPERATURE CABLE
• 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 -1725056; 321 south taylor ave; suite 200; louisville CO 80027
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 21445976
• Report Number: 1018233-2025-01182
• Device Sequence Number: 15438689
• Product Code: DWJ
• UDI-Device Identifier: 00801741080296
• UDI-Public: (01)00801741080296
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup
• Report Date (Section B): 06/23/2025

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: 02/14/2025
• Supplement Date Received by Manufacturer: 06/13/2025; 06/19/2025; 06/23/2025
• Initial Report FDA Received Date: 02/24/2025
• Supplement Report FDA Received Date: 06/18/2025; 06/20/2025; 06/25/2025
• 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