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

Catalog Number	735-02
Medical Device Problem Codes	Erratic or Intermittent Display (1182); Failure to Sense (1559)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the water temperature was not reaching target due to air leak at fluid delivery line connector temperature probe showing intermittent connection in an arctic sun device.Tests showed the delivery hose was leaking air into the system through one of the connectors.Additionally, the temperature probe was giving intermittent readings.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Initial reporter name: (b)(6).The reported product number is unknown.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 water temperature was not reaching target due to air leak at fluid delivery line connector temperature probe showing intermittent connection in an arctic sun device.Tests showed the delivery hose was leaking air into the system through one of the connectors.Additionally, the temperature probe was giving intermittent readings.
Additional Manufacturer Narrative
The reported event was confirmed.The root cause for the reported event is a failed temperature cable.The device was evaluated upon receipt.During evaluation it was found that the temperature cable had failed and was causing intermittent readings in the temperature probe.Temperature cable was replaced.As5000 system passed all tests, is functioning properly and is ready for use.The batch number is unknown.The latest labeling revision will be reviewed for this investigation.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.Initial reporter name: (b)(6) hospital, (b)(6).Corrections: d, f, h.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.

• Brand Name: ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, TEMPERATURE CABLE NELLCOR
• Common Device Name: TEMPERATURE CABLE
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville GA 80027
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 23336384
• Report Number: 1018233-2025-09339
• Device Sequence Number: 9451965
• Product Code: DWJ
• UDI-Device Identifier: 00801741080296
• UDI-Public: (01)00801741080296
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 02/20/2026

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: 735-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2025
• Supplement Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 10/20/2025
• Supplement Report FDA Received Date: 03/07/2026
• 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