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

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.

• Brand Name: HOT DOG PATIENT WARMING SYSTEM
• Type of Device: TORSO 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 Key: 5923380
• MDR Text Key: 54453084
• Report Number: 3005857264-2016-00005
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K112488
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• 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 Received: 09/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B110
• Device Catalogue Number: B110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: WC52 CONTROLLER