MAUDE Adverse Event Report: 3M COMPANY BAIR HUGGER; SYSTEM, THERMAL REGULATING

Model Number 227862

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn, Thermal (2530)

Event Date 12/12/2019

Event Type  malfunction  

Event Description

Placed on underbody bair hugger blanket.No fabric used between patient's skin and bair hugger blanket.Machine turned on approximately 10 min later.The machine was set on medium setting of 38 degrees and was used intermittently throughout the case.When drapes were removed 4 and a half hours later a reddened mark 13cm x 2cm was noted over the right hip and buttock.

• Brand Name: BAIR HUGGER
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): 3M COMPANY; 3m center, 2510 conway ave bldg. 275-5w-06; saint paul MN 55144
• MDR Report Key: 9510633
• MDR Text Key: 172457441
• Report Number: 9510633
• 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: 12/17/2019

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
• Device Operator: Health Professional
• Device Model Number: 227862
• Device Lot Number: 55501
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/17/2019
• Event Location: Hospital
• Date Report to Manufacturer: 12/23/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 270 DA
• Patient Weight: 8