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U.S. Department of Health and Human Services

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

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3M COMPANY BAIR HUGGER SYSTEM, THERMAL REGULATING Back to Search Results
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.
 
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Brand NameBAIR HUGGER
Type of DeviceSYSTEM, THERMAL REGULATING
Manufacturer (Section D)
3M COMPANY
3m center, 2510 conway ave bldg. 275-5w-06
saint paul MN 55144
MDR Report Key9510633
MDR Text Key172457441
Report Number9510633
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received12/23/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number227862
Device Lot Number55501
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/17/2019
Event Location Hospital
Date Report to Manufacturer12/23/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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