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

Catalog Number	60000000L
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2025
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 the nurse from another shift tagged an arctic sun device stated that it was broken.Only message on the device was that it was registering a false patient temperature (pt) that was below the actual patient temperature (pt).Confirmed device was currently not in use.Encouraged to send device to biomed for evaluation.They could simulate patient temperature (pt) to test and determined if there was an issue.Noted clinical helpline was available 24/7 and they could call when the issue was occurring so that they troubleshoot live.
Event or Problem Description
It was reported that the nurse from another shift tagged an arctic sun device stated that it was broken.Only message on the device was that it was registering a false patient temperature (pt) that was below the actual patient temperature (pt).Confirmed device was currently not in use.Encouraged to send device to biomed for evaluation.They could simulate patient temperature (pt) to test and determined if there was an issue.Noted clinical helpline was available 24/7 and they could call when the issue was occurring so that they troubleshoot live.
Additional Manufacturer Narrative
The reported issue was unconfirmed.The root cause of the reported event could not be determined.Reported issue was not reproduced during service.The device was evaluated upon receipt.During the evaluation it was found that the reported issue was not confirmed.The arctic sun stat was put through post repair functional verifications during which the device was heated above 30 degrees c, cooled below 6 degrees c, and the bypass flow was verified adjusted to 1.8 +-.05 l/m at 28 degrees c and -7.0 psi.The fluid delivery line was leak tested and passed.An electrical safety test and ctu calibration were performed and passed.The arctic sun passed functionality testing in compliance with manufacturer specifications, functions normally and is ready for use.The reported event is unconfirmed the risk review is not required.The reported event is unconfirmed, dhr review is not required.The reported event is unconfirmed, labeling/packaging review is not required.No additional actions can be taken at this time.Corrections: d, g, 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.

• Brand Name: ARCTIC SUN STAT
• Common Device Name: ARCTIC SUN DEVICE
• 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: 21697355
• Report Number: 1018233-2025-02031
• Device Sequence Number: 18309825
• Product Code: DWJ
• UDI-Device Identifier: 00801741161520
• UDI-Public: (01)00801741161520(11)200526
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K200225
• 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): 07/15/2025

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: 60000000L
• 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: 03/21/2025
• Supplement Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/26/2020
• 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