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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 775
Device Problems Product Quality Problem (1506); Self-Activation or Keying (1557)
Patient Problem Hypothermia (1915)
Event Date 09/28/2018
Event Type  Malfunction  
Event Description

Anesthesia notified cath lab staff that patient developing hypothermia. Bair hugger appeared to be blowing ambient air on standbye mode. Lowest patient temp 91. 4.

 
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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 Key8101255
MDR Text Key128257560
Report Number8101255
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 RISK MANAGER
Type of Report Initial
Report Date 11/16/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/26/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL Number775
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/16/2018
Event Location No Information
Date Report TO Manufacturer11/26/2018
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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