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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: 3M HEALTH CARE 3M¿ BAIR HUGGER¿ WARMING UNIT 775 SYSTEM THERMAL REGULATING

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3M HEALTH CARE 3M¿ BAIR HUGGER¿ WARMING UNIT 775 SYSTEM THERMAL REGULATING Back to Search Results
Model Number 775
Device Problem Insufficient Heating (1287)
Patient Problem Alteration In Body Temperature (2682)
Event Date 12/18/2017
Event Type  Malfunction  
Manufacturer Narrative

This information was not provided by the hospital. The unit was not returned by the facility for evaluation, therefore analysis testing could not be conducted. The warming units are reusable devices for they are equipment. The unit was not returned by the facility for evaluation, therefore analysis testing could not be conducted. Taking the history of the customer complaint type, trending was reliably used to complete the analysis. The customer would see a lower temperature and code fc007 if the hose was occluded. No injury to the patient was reported. Based on trending this incident remains very low.

 
Event Description

A hospital employee reported a patient (age and gender not specified) was being warmed intraoperatively with 3m ¿ bair hugger¿ warming unit, model 77507. The employee alleged they noticed the patient's temperature was dropping despite the warming device being switched on to a high flow setting at 43 degrees c°. The employee alleged the digital display was reading 23 degrees c° and ambient air was being blown out. A fault verified error code fc007, indicating a faulty end hose sensor was detected. The patient did not require medical intervention.

 
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Brand Name3M¿ BAIR HUGGER¿ WARMING UNIT 775
Type of DeviceSYSTEM THERMAL REGULATING
Manufacturer (Section D)
3M HEALTH CARE
2510 conway ave
st. paul MN 55144
Manufacturer (Section G)
3M COMPANY EDEN PRAIRIE
10351 west 70th street
eden prairie MN 55344
Manufacturer Contact
dianne gibbs
2510 conway ave
3m center, building 275-5w-06
st. paul, MN 55144
6517379117
MDR Report Key8091268
MDR Text Key128028909
Report Number2110898-2018-00106
Device Sequence Number1
Product Code DWJ
Combination Product (Y/N)N
Reporter Country CodeUK
PMA/PMN NumberK001149
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 11/20/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/20/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number775
Device Catalogue Number77507
Device LOT Number23896
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/29/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/08/2011
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 11/20/2018 Patient Sequence Number: 1
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