MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 Arctic Sun® 5000; Arctic Sun Device

Catalog Number	50000000
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Electrolyte Imbalance (2196); Insufficient Information (4580)
Date of Event	07/01/2026
Type of Reportable Event	Serious Injury
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 by critical care nurses in an online survey that a nurse stated that an adverse event was experienced as a result of the chair session, this being: "fever has gone down" while using "arctic sun 5000" with pads "medium (m)".Additionally, a nurse stated that the patient experienced other associated adverse events: electrolyte disturbance (e.G.Hypokalemia, hyperkalemia), and the medical intervention was: " substitute irrigation".While using "arctic sun 5000" with pads "medium (m)".A01 reaction against device 5000.Additionally, a nurse stated that an adverse event was experienced as a result of the chair session, this being: "fever has gone down " while using "arctic sun 5000" with pads "large (l)".Additionally, a nurse stated that the patient experienced other associated adverse events: electrolyte disturbance (e.G.Hypokalemia, hyperkalemia), and the medical intervention was: "substitute irrigation".While using "arctic sun 5000" with pads "large (l)".A01 reaction against device 5000.Additionally, a nurse stated that the patient experienced other associated adverse events: electrolyte disturbance (e.G.Hypokalemia, hyperkalemia), and the medical intervention was: "substitute irrigation".While using "arctic sun 5000" with pads "unsure/not documented in patient chart".A01 reaction against device 5000.Additionally, a nurse stated that the patient experienced other associated adverse events: electrolyte disturbance (e.G.Hypokalemia, hyperkalemia), and the medical intervention was: "substitute irrigation.¿ while using "arctic sun 5000" with pads "unsure/not documented in patient chart".A01 reaction against device 5000.Additionally, a nurse stated that the patient experienced other associated adverse events: electrolyte disturbance (e.G.Hypokalemia, hyperkalemia), and the medical intervention was: "substitute irrigation.¿ while using "arctic sun 5000" with pads "medium (m)".A01 reaction against device 5000.Additionally, a nurse stated that the patient experienced other associated adverse events: electrolyte disturbance (e.G.Hypokalemia, hyperkalemia), and the medical intervention was: "substitute irrigation.¿.While using "arctic sun 5000" with pads "large (l)".A01 reaction against device 5000.
Event or Problem Description
It was reported critical care nurses reported in an online survey that a nurse stated that an adverse event was experienced as a result of the chair session, this being: "fever has gone down" while using "arctic sun 5000" with pads "medium (m)".Additionally, a nurse stated that the patient experienced other associated adverse events: electrolyte disturbance (e.G.Hypokalemia, hyperkalemia), and the medical intervention was: " substitute irrigation".While using "arctic sun 5000" with pads "medium (m)".A01 reaction against device 5000.Additionally, a nurse stated that an adverse event was experienced as a result of the chair session, this being: "fever has gone down " while using "arctic sun 5000" with pads "large (l)".Additionally, a nurse stated that the patient experienced other associated adverse events: electrolyte disturbance (e.G.Hypokalemia, hyperkalemia), and the medical intervention was: "substitute irrigation".While using "arctic sun 5000" with pads "large (l)".A01 reaction against device 5000.Additionally, a nurse stated that the patient experienced other associated adverse events: electrolyte disturbance (e.G.Hypokalemia, hyperkalemia), and the medical intervention was: "substitute irrigation".While using "arctic sun 5000" with pads "unsure/not documented in patient chart".A01 reaction against device 5000.Additionally, a nurse stated that the patient experienced other associated adverse events: electrolyte disturbance (e.G.Hypokalemia, hyperkalemia), and the medical intervention was: "substitute irrigation.¿ while using "arctic sun 5000" with pads "unsure/not documented in patient chart".A01 reaction against device 5000.Additionally, a nurse stated that the patient experienced other associated adverse events: electrolyte disturbance (e.G.Hypokalemia, hyperkalemia), and the medical intervention was: "substitute irrigation.¿ while using "arctic sun 5000" with pads "medium (m)".A01 reaction against device 5000.Additionally, a nurse stated that the patient experienced other associated adverse events: electrolyte disturbance (e.G.Hypokalemia, hyperkalemia), and the medical intervention was: "substitute irrigation.¿.While using "arctic sun 5000" with pads "large (l)".A01 reaction against device 5000.
Additional Manufacturer Narrative
Received condition: the device was not returned.Reported issue: additionally, a nurse stated that the patient experienced other associated adverse events: electrolyte disturbance (e.G.Hypokalemia, hyperkalemia), and the medical intervention was: "substitute irrigation.¿ while using "arctic sun 5000" with pads "unsure/not documented in patient chart".A01 reaction against device 5000.Reported issue root cause: at this time, the root cause of the reported event could not be determined.Repairs related to the reported issue: no additional information received at this time.The reported issue was inconclusive.At this time, the root cause of the reported event could not be determined.No additional information received at this time.The labeling/ifu revision accompanying this serial number is not recorded in the dhr.The latest labeling revision will be reviewed for this investigation.A dhr review is not required as the serial number is unknown.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.

• 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 80027
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; +1(770)784-6100
• MDR Report Key: 25820137
• Report Number: 1018233-2026-04631
• Device Sequence Number: 16135892
• Product Code: DWJ
• UDI-Device Identifier: 00801741080142
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 07/30/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 50000000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2026
• Supplement Date Received by Manufacturer: 07/20/2026; Not provided
• Initial Report FDA Received Date: 07/14/2026
• Supplement Report FDA Received Date: 07/27/2026; 07/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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