MAUDE Adverse Event Report: AUGUSTINE BIOMEDICAL & DESIGN, LLC HOT DOG WARMING DEVICE; PATIENT WARMING MULTI-POSITION BLANKET

Model Number B110

Device Problems Melted (1385); Device Emits Odor (1425); Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/01/2016

Event Type  malfunction  

Manufacturer Narrative

Hospital reported that patient was immediately examined and there was no injury.Photographs furnished on (b)(6) 2016 indicate excess heat along some areas of the external shell.Device has not been returned.Several requests have been made for the return of the device to enable our evaluation.A supplemental report will be issued upon device return and evaluation.

Event Description

International sales distributor advised via email that a(b)(6) hospital had filed a device adverse report with (b)(6).The content of the (b)(6) report was received (b)(6) 2016: staff were preparing the patient for their surgery with the top warming mattress on.The anaesthetist smelt burning and noticed smoke.She alerted everyone immediately and removed the warming mat.They checked the patient thoroughly and there was no sign of damage to the patient at all.The warming mat was melted in a long strip down the side and along some areas of the exterior shell.

• Brand Name: HOT DOG WARMING DEVICE
• Type of Device: PATIENT WARMING MULTI-POSITION BLANKET
• 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 ; 6581 city west parkway; eden prairie, MN 55344 ; 9524653512
• MDR Report Key: 5591363
• MDR Text Key: 44123406
• Report Number: 3005857264-2016-00002
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2016
• 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?: Yes
• Date Manufacturer Received: 03/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2013
• 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