MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 Arctic Sun® Temperature Management System, ArcticGel¿ Pads; System, Thermal Regulating

Catalog Number	318-02
Medical Device Problem Code	Inaccurate Flow Rate (1249)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2026
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: 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 they were getting alarm 02 (low flow) in an arctic sun device.Flow rate was 0.5 to 0.8lpm, inlet pressure (ip) was -7psi, circulation pump command (cpc) was 34 percentage, pump hours were 3561.4 and system hours were 2056.Asked nurse to try to identify if the pad tubing was compressed or kinked anywhere.They found one location where the tubing meets the pad but was unable to open it up.Flow remains between 0 to 0.9 lpm.Patient at target 33.5c.Asked nurse to watch patient temperature and flow rate.If the flow rate decreases the heater would not be able to perform at full capacity.If the water temperature did not increase as expected or if they receive alarm 113 (reduced water temperature control), replace the pad.Per follow up information received via task on 07may2026, spoke with charge nurse who confirmed pad was exchanged because they could not keep a stable flow rate.Pad was a single neonate pad and has been retained in office at the moment.Requested a box.

• Brand Name: Arctic Sun® Temperature Management System, ArcticGel¿ Pads
• Common Device Name: System, Thermal Regulating
• 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 ; +1(770)784-6100
• MDR Report Key: 25144100
• Report Number: 1018233-2026-03086
• Device Sequence Number: 21183908
• Product Code: DWJ
• UDI-Device Identifier: 00801741132131
• UDI-Public: (01)00801741132131
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K142702
• 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): 07/23/2026

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: 318-02
• 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: 05/05/2026
• Supplement Date Received by Manufacturer: 07/23/2026
• Initial Report FDA Received Date: 05/11/2026
• Supplement Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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