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

Catalog Number	60000000L
Medical Device Problem Code	Computer Operating System Problem (2898)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2025
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.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 they had alarm 64 (non-recoverable system error control processor) in an arctic sun device.The device was unable to enable pump power (control processor).Turn the control module off.Wait 30 seconds and turn the control module on.If alarm persists, send device to biomed.Had nurse press continue current patient, and empty pads.Therapy resumed.
Event or Problem Description
It was reported that they had alarm 64 (non-recoverable system error control processor) in an arctic sun device.The device was unable to enable pump power (control processor).Turn the control module off.Wait 30 seconds and turn the control module on.If alarm persists, send device to biomed.Had nurse press continue current patient, and empty pads.Therapy resumed.
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.
Additional Manufacturer Narrative
The reported issue was inconclusive.The root cause for the reported event could not be determined.The device was unable to enable pump power (control processor).Turn the control module off.Wait 30 seconds and turn the control module on.If alarm persists, send device to biomed.Had nurse press continue current patient, and empty pads.Therapy resumed.Per follow up information received via task on 23apr2025, per review of event, bd representative successfully troubleshot the malfunction during the call.The event concluded with the device working and the patient on the trajectory for successful therapy completion.The complaint or reported issue was confirmed through other elements of the investigation to not be manufacturing related.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.Corrections: 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 they had alarm 64 (non-recoverable system error control processor) in an arctic sun device.The device was unable to enable pump power (control processor).Turn the control module off.Wait 30 seconds and turn the control module on.If alarm persists, send device to biomed.Had nurse press continue current patient, and empty pads.Therapy resumed.Per follow up information received via task on 23apr2025, per review of event, bd representative successfully troubleshot the malfunction during the call.The event concluded with the device working and the patient on the trajectory for successful therapy completion.

• 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, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville 80027
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 21356773
• Report Number: 1018233-2025-00808
• Device Sequence Number: 15412825
• Product Code: DWJ
• UDI-Device Identifier: 00801741161520
• UDI-Public: (01)00801741161520(11)200930
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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,Followup
• Report Date (Section B): 07/16/2025

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2025
• Supplement Date Received by Manufacturer: 03/21/2025; 07/16/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 03/24/2025; 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/30/2020
• 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