MAUDE Adverse Event Report: MEDIVANCE -1725056 ARCTIC SUN® 5000; ARCTIC SUN DEVICE

Catalog Number	50000000L
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2025
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 biomed doing functional check on arctic sun device loaner just received and stated the inlet pressure (ip) was not reaching -7psi.
Additional Manufacturer Narrative
The reported event was unconfirmed.The root cause for the reported event could not be determined as the reported event was unconfirmed.The device was evaluated upon receipt.During evaluation the device was found to be fully functional.Graphics software was updated from 3.0.2 to 3.3.0.All applicable upgrades were completed or verified complete.Reset the device to default settings which included deleting any patient data that was currently on the device.The arctic sun 5000 was functionally tested for compliance with manufacturer specifications.An electrical safety test and ctu calibration were performed and passed.Fdl was inspected and tested.A dhr review is not required as the reported event is unconfirmed.A risk review is not required as the reported event is unconfirmed.A labeling review is not required as the reported event is unconfirmed.Based on the results of the investigation, no additional actions are needed.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.
Event or Problem Description
It was reported that the biomed doing functional check on arctic sun device loaner just received and stated the inlet pressure (ip) was not reaching -7psi.

• Brand Name: ARCTIC SUN® 5000
• Common Device Name: ARCTIC SUN DEVICE
• Manufacturer (Section D): MEDIVANCE -1725056; 321 south taylor ave; suite 200; louisville CO 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: 23584800
• Report Number: 1018233-2025-10368
• Device Sequence Number: 9398828
• Product Code: DWJ
• UDI-Device Identifier: 00801741080159
• UDI-Public: (01)00801741080159(11)151201
• 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
• Report Date (Section B): 03/25/2026

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2025
• Supplement Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2015
• 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