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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: 3M HEALTH CARE 3M BAIR HUGGER¿ WARMING UNIT HYPER/HYPOTHERMA SYSTEM

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3M HEALTH CARE 3M BAIR HUGGER¿ WARMING UNIT HYPER/HYPOTHERMA SYSTEM Back to Search Results
Model Number 775
Device Problem Temperature Problem (3022)
Patient Problems Hypothermia (1915); No Known Impact Or Consequence To Patient (2692)
Event Date 09/01/2018
Event Type  Injury  
Manufacturer Narrative

Expiration date is not applicable to the unit. The device has not been returned by the customer for evaluation. Multiple attempts have been made to contact the individual who reported the incident. To date, no response has been received. No additional information has been provided. The device was not returned for evaluation, therefore unit fault codes, if applicable, could be not be investigated or verified. Trending was reliably used taking the history of the customer complaint type. The failure rate for the reported incident is low. 3m will continue to monitor the product line for future failure trends. If additional information becomes available a follow up report will be submitted.

 
Event Description

A hospital risk manager alleged anesthesia notified the cath lab a (b)(6) year old patient (gender not specified) developed hypothermia while using a 3m ¿ bair hugger ¿ warming unit, model 775, serial # (b)(4). No details are known as to the temperature or the duration of heating during this time. 3m ¿ bair hugger ¿ blanket model number used was not specified. Exact date of incident was not specified. Event was reported to have occurred in (b)(6) 2018. The employee alleged the lowest patient temperature recorded was 91. 4° f. The employee alleged the bair hugger ¿ appeared to be blowing ambient air while on standby mode. Medical treatment was not specified.

 
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Brand Name3M BAIR HUGGER¿ WARMING UNIT
Type of DeviceHYPER/HYPOTHERMA SYSTEM
Manufacturer (Section D)
3M HEALTH CARE
2510 conway ave.
3m center, building 275-5w-06
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 Key8204509
MDR Text Key131728587
Report Number2110898-2018-00115
Device Sequence Number1
Product Code DWJ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK960167
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,HEALTH PROFESSION
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 12/28/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/28/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number775
Device Catalogue Number77500
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/03/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/05/2012
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: 12/28/2018 Patient Sequence Number: 1
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