MAUDE Adverse Event Report: MEDIVANCE, INC. ARCTIC SUN® 5000; SYSTEM, THERMAL REGULATING

Model Number 50000000

Device Problem Temperature Problem (3022)

Patient Problem Alteration in Body Temperature (4568)

Event Date 07/29/2022

Event Type  malfunction  

Event Description

Neonatal intensive care unit (nicu) patient receiving therapeutic hypothermia for hypoxic ischemic encephalopathy; it was noted during afternoon and evening that the arctic sun equipment that regulates the baby's temperature was not functioning correctly and the baby's temp was 34 degrees c instead of the goal 33.5 degrees c.Tech support was contacted and it was determined that the "mixing pump" was not functioning properly.There was nothing that could be done to repair it at the time.Intensive care unit, emergency room, and operating room were contacted in an attempt to acquire replacement equipment.An exact replacement was not available, but similar equipment was found.Patient temperature returned to the goal of 33.5 degrees c.

• Brand Name: ARCTIC SUN® 5000
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): MEDIVANCE, INC.; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 15502975
• MDR Text Key: 300798388
• Report Number: 15502975
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 50000000
• Device Catalogue Number: 50000000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/15/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/29/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 2 DA
• Patient Sex: Female
• Patient Weight: 4 KG