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

Catalog Number	735-02
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the temperature probe was not reading accurately and arctic sun device rewarming very slowly.Per review of wo on 03mar2025, device was used on patient and moved to another unit.
Additional Manufacturer Narrative
The complete initial reporter phone number is (b)(6).The complete initial reporter facility name is leeds general infirmary receipt & distribution, 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.
Additional Manufacturer Narrative
The reported issue was confirmed.The root cause identified is a failed temp cable.The device was evaluated upon receipt.Temperature cable not working.Replaced temp cable.It was reported that device rewarming very slowly, but machine rewarming above 30 c within 10 minutes as per verification check.The as5000 system was evaluated for functionality and results were recorded.An electrical safety test was performed; as5000 system passed all tests, is functioning properly and is ready for use.(b)(4) rev 25 was reviewed for this investigation.The reported event is addressed in step #ra15.Based on this review the risk is within the expected range.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/serial 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 temperature probe was not reading accurately and arctic sun device rewarming very slowly.Per review of wo on 03mar2025, device was used on patient and moved to another unit.Per follow up information received via mail on 03mar2025, the device was not here yet.Per follow up information received via mail on 04mar2025, awaiting unit¿s arrival.The issue was not resolved yet.There was no reported patient impact the device was sent with reported fault of not regulating patient temperature.
Additional Manufacturer Narrative
Correction: b, d, e, f, h.The initial reporter phone number is (b)(6).The complete initial reporter facility name is leeds general infirmary receipt & distribution.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 temperature probe was not reading accurately and arctic sun device rewarming very slowly.Per review of wo on 03mar2025, device was used on patient and moved to another unit.Per follow up information received via mail on 03mar2025, the device was not here yet.Per follow up information received via mail on 04mar2025, awaiting unit¿s arrival.The issue was not resolved yet.There was no reported patient impact the device was sent with reported fault of not regulating patient temperature.

• Brand Name: ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, TEMPERATURE CABLE
• Common Device Name: 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: 21514781
• Report Number: 1018233-2025-01423
• Device Sequence Number: 12755930
• 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,Followup
• Report Date (Section B): 07/22/2025

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: 02/27/2025
• Supplement Date Received by Manufacturer: 07/17/2025; 07/22/2025
• Initial Report FDA Received Date: 03/04/2025
• Supplement Report FDA Received Date: 07/18/2025; 07/23/2025
• 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