MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS; NEONATAL ARCTIC GEL PADS

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	03/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter complete facility name: (b)(6).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.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 neonatal intensive care unit (nicu) nurse stated the flow rate was 0.9lpm.Device was alerting low flow (02).Guided to diagnostics showed that the system hours were 2553, pump hours were 2360, inlet pressure (ip) was -7psi, circulation pump command (cpc) was 33 percentage, flow rate (fr) was 0.9lpm.They confirmed tubing was straight.Advised to call back if flow rate (fr) dropped below 0.7lpm.Explained correlation between heater capacity and flow rate.Per follow up information received via task on 10mar2026, spoke with charge nurse who confirmed patient completed therapy with the same neonate size pad.If around 0.7 lpm was the appropriate flow rate for a neonate pad because has seen flow up to 3.0 lpm.Explained the expected flow rate for a neonate pad should be 1.0 but that the heater would continue to engage if it was above 0.5 lpm.Requested tm be notified to send all the neonate pad calls from the past 12 months.Pad was disposed of.

• Brand Name: ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS
• Common Device Name: NEONATAL ARCTIC GEL PADS
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville GA 80027
• Manufacturer (Section G): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville GA 80027
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 24594108
• Report Number: 1018233-2026-01697
• Device Sequence Number: 10355307
• Product Code: DWJ
• UDI-Device Identifier: 00801741132131
• UDI-Public: (01)00801741132131
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 05/22/2026

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2026
• Supplement Date Received by Manufacturer: 05/22/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 06/03/2026
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown