MAUDE Adverse Event Report: BARD ARCTIC SUN; TEMPERATURE MANAGEMENT SYSTEM

Model Number 5000

Device Problem Overheating of Device (1437)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 12/25/2016

Event Type  Injury  

Event Description

Patient receiving ttm therapy - h20 temp in pads reached 104 degrees and remained at 104 degrees for 12 hours.Oncoming day shift rn checked patient's skin and the arctic sun pads literally tore patient's skin off each extremity upon removal of these pads.Blisters and burns noted.

• Brand Name: ARCTIC SUN
• Type of Device: TEMPERATURE MANAGEMENT SYSTEM
• Manufacturer (Section D): BARD; covington GA
• MDR Report Key: 6217910
• MDR Text Key: 63820244
• Report Number: MW5067008
• Device Sequence Number: 1
• Product Code: DWJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5000
• Device Lot Number: 5000-00-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR