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

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Alteration in Body Temperature (4568)

Event Date 08/18/2022

Event Type  malfunction  

Event Description

Arctic sun body cooling device reading appropriate esophageal and rectal temperatures for targeted cooling temperature.Arctic sun began displaying alerts around 0300 that patient's body temp was unstable, thus stopping therapy, despite body temperatures displaying as desired.Connections to temperature probes and the placement of probes checked.Multiple rns asked to trouble shoot cooling device, and cooling device restarted each time.After multiple alarms, rn checked a manual rectal temperature - 97.9.Arctic sun help line called and troubleshooted.Arctic sun technician had concerns the machine was not working properly and walked rn through correcting the issue.Esophageal probe also switched so that rectal was primary and esophageal was secondary - told by technician to leave them in this order.Md notified of event and infant continued body cooling.Patient had moved bed spots and arctic sun was unplugged and restarted around 3 hours prior to event.Once the patient was moved however, therapy was continued from current settings.

• Brand Name: ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): MEDIVANCE, INC.; 321 south taylor avenue; suite 200; louisville CO 80027
• MDR Report Key: 16938534
• MDR Text Key: 315295576
• Report Number: 16938534
• 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: 04/19/2023,09/14/2022

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/19/2023
• Event Location: Hospital
• Date Report to Manufacturer: 05/16/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/16/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Race: White