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

Model Number 50000000E

Patient Problem Alteration in Body Temperature (4568)

Event Date 06/21/2023

Event Type  malfunction  

Event Description

Infant being cooled in regional neonatal intensive care unit (rnicu) on arctic sun mattress.Machine alarmed to say that the mattress that had been on infant for ~36 hours was not regulating properly anymore.Therapy was continued, but quickly noticed that infant temperature continued to drop while water temperature in the pads was not compensating for this.Infant temperature got down to 32.8 c (regulating at 33.5 c).Arctic sun mattress pad was quickly switched out and new pad worked correctly.Manufacturer response for cooling pad, artic sun (per site reporter).The representative reached out to follow up from my phone call and disclosed that this has been happening with increased frequency of calls to them related to neonatal pads, so someone from the company went to the mexico plant and watched how they were made/stored and found they were stacked in their silver packages pretty high and the packages on the bottom were getting squished, so the hose line was getting hydrogel in it, thus impacting how much flow could go through the pad.

• Brand Name: ARCTIC SUN
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): MEDIVANCE, INC.; 321 south taylor avenue; suite 200; louisville CO 80027
• MDR Report Key: 17867794
• MDR Text Key: 324909026
• Report Number: 17867794
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 09/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 50000000E
• Device Catalogue Number: 50000000E
• Device Lot Number: NGGX2900 OR NGHQ2940
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/28/2023
• Event Location: Hospital
• Date Report to Manufacturer: 10/04/2023
• 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: Male