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	06/04/2025
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 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 patient temperature was not registering correctly on arctic sun device.Axillary & oral 36.8c esophageal reading 36.9c on monitor, but 33.5c on the arctic sun device.Had them check cable connections and no change noted.When flex cable the temperature jumped 2+ degrees.Advised to swap out temperature in cable.Contact biomed if they don't have another one on the floor.
Event or Problem Description
It was reported that the patient temperature was not registering correctly on arctic sun device.Axillary & oral 36.8c esophageal reading 36.9c on monitor, but 33.5c on the arctic sun device.Had them check cable connections and no change noted.When flex cable the temperature jumped 2+ degrees.Advised to swap out temperature in cable.Contact biomed if they don't have another one on the floor.Per follow up information received via phone on 30jun2025, spoke with nurse who confirmed they exchanged the cable for another nellcor cable.The original cable was disposed of without evaluation.No further issues after cable exchange.
Additional Manufacturer Narrative
The reported issue was confirmed.The root cause of the reported issue is a failed temperature cable.A dhr is not required as the lot number is unknown.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.Correction: d, g.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.
Additional Manufacturer Narrative
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 patient temperature was not registering correctly on arctic sun device.Axillary & oral 36.8c esophageal reading 36.9c on monitor, but 33.5c on the arctic sun device.Had them check cable connections and no change noted.When flex cable the temperature jumped 2+ degrees.Advised to swap out temperature in cable.Contact biomed if they don't have another one on the floor.Per follow up information received via phone on 30jun2025, spoke with nurse who confirmed they exchanged the cable for another nellcor cable.The original cable was disposed of without evaluation.No further issues after cable exchange.

• 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: 22187002
• Report Number: 1018233-2025-04436
• Device Sequence Number: 12888229
• Product Code: DWJ
• UDI-Device Identifier: 00801741080296
• UDI-Public: (01)00801741080296
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,Followup
• Report Date (Section B): 07/02/2025

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: 06/04/2025
• Supplement Date Received by Manufacturer: 07/01/2025; 07/02/2025
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 07/02/2025; 07/08/2025
• 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