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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARIZANT BAIR HUGGER-TEMPERATURE MANAGEMENT BLANKET - LOWER BODY DISPOSABLE WARMING BLANKET

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ARIZANT BAIR HUGGER-TEMPERATURE MANAGEMENT BLANKET - LOWER BODY DISPOSABLE WARMING BLANKET Back to Search Results
Model Number 42568
Event Date 05/03/2012
Event Type  Malfunction  
Event Description

A patient sustained second degree burns on the left and right anterior/ medial thighs with clear vesicles/blisters in grid distribution. The total area of thermal burn on the left thigh measured approximately 15 x 15 cm. The right medial thigh had erythemic lesions and clear vesicles/ blisters in grid distribution. The total area measured approximately 10x2 cm. Operating roomsstaff validated that the hose was connected to the inflatable blanket. The arizant bair hugger manufacturer temperature specification is 43c +/-3c. The actual temperature tested 48. 7c. High temperature alarm of 53c was not reached. ======================manufacturer response for patient blanket warmer, bair hugger model 505 (per site reporter). ======================the sales manager took my information and said the technical support will contact me to exchange unit for testing. ======================manufacturer response for disposable warming blanket, bair hugger-temperature management blanket - lower body (per site reporter). ======================technical support is going to call me back with directions for the 505 warming unit.

 
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Brand NameBAIR HUGGER-TEMPERATURE MANAGEMENT BLANKET - LOWER BODY
Type of DeviceDISPOSABLE WARMING BLANKET
Manufacturer (Section D)
ARIZANT
10393 w. 70th st.
eden prairie MN 55344
MDR Report Key2571151
Report Number2571151
Device Sequence Number2
Product CodeDWJ
Report Source User Facility
Type of Report Initial
Report Date 05/10/2012
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received05/10/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator INVALID DATA
Device MODEL Number42568
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/10/2012
Event Location Hospital

Patient TREATMENT DATA
Date Received: 05/10/2012 Patient Sequence Number: 1
Treatment
NO OTHER THERAPIES
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