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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AUGUSTINE BIOMEDICAL & DESIGN HOT DOG PATIENT WARMING SYSTEM TORSO WARMING BLANKET, V-SHAPED

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AUGUSTINE BIOMEDICAL & DESIGN HOT DOG PATIENT WARMING SYSTEM TORSO WARMING BLANKET, V-SHAPED Back to Search Results
Model Number B110
Device Problems Break (1069); Thermal Decomposition of Device (1071); Melted (1385); Device Emits Odor (1425)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/02/2016
Event Type  malfunction  
Event Description
Per clinical site information: the consultant anesthetist noticed a faint electrical burning smell and asked the theatre staff if they could smell it also which they could not. A check of the area was made to no avail. The odp checked the patient's warming equipment and it was discovered that the bed sheet covering the patient had a burn mark approximately the same size as a (b)(6) coin. The hot dog warming blanket was removed and observed to have a melted element approximately 300mm long with areas of exposed element wire. The patient was assessed for any signs of injury and which there were no visible signs.
 
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Brand NameHOT DOG PATIENT WARMING SYSTEM
Type of DeviceTORSO WARMING BLANKET, V-SHAPED
Manufacturer (Section D)
AUGUSTINE BIOMEDICAL & DESIGN
6581 city west parkway
eden prairie 55344
Manufacturer (Section G)
AUGUSTINE BIOMEDICAL & DESIGN
6581 city west parkway
eden praire MN 55344
Manufacturer Contact
jasper blake
6581 city west parkway
eden prairie, MN 55344
9524653512
MDR Report Key5923380
MDR Text Key54453084
Report Number3005857264-2016-00005
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K112488
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/17/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/01/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberB110
Device Catalogue NumberB110
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/13/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/04/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2014
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: 09/01/2016 Patient Sequence Number: 1
Treatment
WC52 CONTROLLER
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