MAUDE Adverse Event Report: BD / C. R. BARD, INC. ARTIC SUN TEMPERATURE MANAGEMENT SYSTEM; SYSTEM, THERMAL REGULATING

Model Number 5000

Device Problem Temperature Problem (3022)

Patient Problem Full thickness (Third Degree) Burn (2696)

Event Date 01/26/2022

Event Type  Injury  

Event Description

Pt admitted with left mca stroke.Placed on artic sun for refractory temperature.The temp remained around 5 degrees celsius.When the pads were removed in the morning.The pt was noted to have 1st degree burns that progressed to full thickness burns.

• Brand Name: ARTIC SUN TEMPERATURE MANAGEMENT SYSTEM
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): BD / C. R. BARD, INC.
• MDR Report Key: 13975450
• MDR Text Key: 288362399
• Report Number: MW5108673
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: 5000
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 39 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White