MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN 5000; ARCTIC SUN DEVICE

Catalog Number	50000000L
Medical Device Problem Code	Circuit Failure (1089)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The 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 while operating the sn: (b)(6) arctic sun device, the nicu nurse encountered an error message stating.Requested data not placed into memory because of an i/o error.Upon acknowledging the message by pressing ""ok,"" the device screen froze and became unresponsive.The malfunctioning device was promptly replaced with a functional unit sourced from the adult care department to ensure continuity of patient care.User was guided to the settings menu and adjusted the low water level (lwl) to 10.The high-water level (hwl) was already set to 40°c, as the replacement device was a stat unit.Rewarm tab reads from 34.2°c to 36.5°c at a rate of 0.5°c per hour.The patient¿s current temperature was 33.8°c.The user reported that the reservoir felt cold upon receiving the device from the adult unit but confirmed that everything appears to be functioning properly now.
Additional Manufacturer Narrative
The reported issue was inconclusive.At this time, the root cause of the reported event could not be determined.The malfunctioning device was promptly replaced with a functional unit sourced from the adult care department to ensure continuity of patient care.User was guided to the settings menu and adjusted the low water level (lwl) to 10.The high-water level (hwl) was already set to 40°c, as the replacement device was a stat unit.Rewarm tab reads from 34.2°c to 36.5°c at a rate of 0.5°c per hour.The patient¿s current temperature was 33.8°c.The user reported that the reservoir felt cold upon receiving the device from the adult unit but confirmed that everything appears to be functioning properly now.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 a dhr is not required as the device has undergone previous servicing and therefore the reported issue is not manufacturing related.Correction: d 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 while operating the sn: dyavy113 arctic sun device, the nicu nurse encountered an error message stating.Requested data not placed into memory because of an i/o error.Upon acknowledging the message by pressing ""ok,"" the device screen froze and became unresponsive.The malfunctioning device was promptly replaced with a functional unit sourced from the adult care department to ensure continuity of patient care.User was guided to the settings menu and adjusted the low water level (lwl) to 10.The high-water level (hwl) was already set to 40°c, as the replacement device was a stat unit.Rewarm tab reads from 34.2°c to 36.5°c at a rate of 0.5°c per hour.The patient¿s current temperature was 33.8°c.The user reported that the reservoir felt cold upon receiving the device from the adult unit but confirmed that everything appears to be functioning properly now.

• Brand Name: ARCTIC SUN 5000
• Common Device Name: ARCTIC SUN DEVICE
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville 80027
• Manufacturer (Section G): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville CO 80027
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 22194232
• Report Number: 1018233-2025-04476
• Device Sequence Number: 15887590
• Product Code: DWJ
• UDI-Device Identifier: 00801741080159
• UDI-Public: (01)00801741080159(11)160825
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 08/20/2025

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: 50000000L
• 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: 06/07/2025
• Supplement Date Received by Manufacturer: 08/20/2025
• Initial Report FDA Received Date: 06/12/2025
• Supplement Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/25/2016
• 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