MAUDE Adverse Event Report: AUGUSTINE BIOMEDICAL & DESIGN, LLC HOT DOG PATIENT WARMING SYSTEM; B110 TORSO WARMING BLANKET, V-SHAPED

Model Number B110

Device Problems Intermittent Continuity (1121); Overheating of Device (1437); Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/21/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4): we have assessed this report and decided not to investigate this specific incident at this time.The warming blanket was eval and found to have mechanical and electrical failures caused by excessive wear.

Event Description

Sales distributor advised via email that a (b)(6) hospital had filed an adverse incident report with (b)(6).Extracted from report (b)(4): after placing a torso hot dog warming device on the pt, prior to surgery commencing, ensure that the blanket was not in contact with the pt's bare skin, by using the pt's gown and inco sheet, the device was stitched on.Within approx five minutes, the smell of electrical burning was apparent.The warming devices were immediately switched off and unplugged.Blanket taken out of circulation.

• Brand Name: HOT DOG PATIENT WARMING SYSTEM
• Type of Device: B110 TORSO WARMING BLANKET, V-SHAPED
• Manufacturer (Section D): AUGUSTINE BIOMEDICAL & DESIGN, LLC; 6581 city west parkway; eden prairie MN 55344
• Manufacturer (Section G): AUGUSTINE BIOMEDICAL & DESIGN, LLC; 6581 city west parkway; eden prairie MN 55344
• Manufacturer Contact: jasper blake, quality ; 6581 city west parkway; eden prairie, MN 55344 ; 9524653500
• MDR Report Key: 5346785
• MDR Text Key: 35649736
• Report Number: 3005857264-2015-00007
• 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: distributor,health profession
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2011
• 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
• Patient Outcome(s): Other