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

Model Number 42568

Device Problem Temperature Problem (3022)

Patient Problem Partial thickness (Second Degree) Burn (2694)

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.

• Brand Name: BAIR HUGGER-TEMPERATURE MANAGEMENT BLANKET - LOWER BODY
• Type of Device: DISPOSABLE WARMING BLANKET
• Manufacturer (Section D): ARIZANT; 10393 w. 70th st.; eden prairie MN 55344
• MDR Report Key: 2571151
• MDR Text Key: 18060887
• Report Number: 2571151
• Device Sequence Number: 2
• Product Code: DWJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• 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 Received: 05/10/2012
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Model Number: 42568
• 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 FDA: 05/10/2012
• Event Location: Hospital

Patient Treatment Data

Date Received: 05/10/2012 Patient Sequence Number: 1

Treatment

NO OTHER THERAPIES