MAUDE Adverse Event Report: MEDIVANCE -1725056 ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, TEMPERATURE CABLE NELLCOR

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	07/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complete initial reporter facility name is (b)(6) hospital: (b)(6) hospital.The initial reporter phone number that was provided was (b)(6).The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.All available udi information is being provided.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 patient's temperature did not appear on lcd window, even though a new temperature probe cable was connected in an arctic sun device.Per additional information received via mail on 16jul2025, they will check the device on site.Temperature in cable was expected to be a problem.Not confirmed yet.
Event or Problem Description
It was reported that the patient's temperature did not appear on lcd window, even though a new temperature probe cable was connected in an arctic sun device.Per additional information received via mail on 16jul2025, they will check the device on site.Temperature in cable was expected to be a problem.Not confirmed yet.
Additional Manufacturer Narrative
The initial reporter's phone number: (b)(6).The reported issue was confirmed.The root cause of the reported issue is due to a failed temperature in cable.During testing, the temperature simulator connected to the temperature in cable connected temp 1, but temp 1 was not displayed on the screen.After replacing the normal temperature in cable for testing, i connected the temperature simulator and the patient's temperature was displayed normally on temp 1.Temperature in cable was replaced.This device was evaluated for functionality.It passed all tests successfully.The evaluation found no other issues with the arcticsun performance.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.Based on the results of the investigation, no additional actions are needed.Corrections: 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.
Additional Manufacturer Narrative
The complete initial reporter facility name is (b)(6).The initial reporter phone number that was provided was (b)(6).The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Correction: d all available udi information is being provided.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 patient's temperature did not appear on lcd window, even though a new temperature probe cable was connected in an arctic sun device.Per additional information received via mail on (b)(6) 2025, they will check the device on site.Temperature in cable was expected to be a problem.Not confirmed yet.

• Brand Name: ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, TEMPERATURE CABLE NELLCOR
• Common Device Name: TEMPERATURE CABLE
• Manufacturer (Section D): MEDIVANCE -1725056; 321 south taylor ave; suite 200; louisville CO 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: 22530643
• Report Number: 1018233-2025-05928
• Device Sequence Number: 15436964
• Product Code: DWJ
• UDI-Device Identifier: 00801741080296
• UDI-Public: (01)00801741080296
• 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): 12/12/2025

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: 07/14/2025
• Supplement Date Received by Manufacturer: 11/25/2025; 12/12/2025
• Initial Report FDA Received Date: 07/17/2025
• Supplement Report FDA Received Date: 11/26/2025; 12/19/2025
• 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