MAUDE Adverse Event Report: AUGUSTINE BIOMEDICAL & DESIGN, LLC HOT DOG PATIENT WARMING SYSTEM; B103 LOWER BODY WARMING BLANKET

Model Number B103

Device Problems Thermal Decomposition of Device (1071); Electrical /Electronic Property Problem (1198); Fracture (1260); Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/03/2016

Event Type  malfunction  

Manufacturer Narrative

The hospital noticed the event after the procedure; there was no impact to patient, and the event was not considered life threatening.The returned warming blanket was evaluated.Observations of the out of warranty blanket: material wear and compromise of the power wire insulation jacket via repetitive kinking; continued flexing is thought to allow some portion of the wire to breach insulation, and created localized energy associated with discoloration and thermal decomposition of the heater fabric and shell material - approximately 0.07 square inches in size.

Event Description

As reported by the hospital via distributor: after the procedure when blankets were removed, the user noticed a hole that gave away some smoke and a burning smell.Medical procedure was 28 minutes (trepanation et evacuation haematomatis chronicum) or removal of a blood hematoma from the subdural space.Condition of patient: stable at start of procedure; stable at end of procedure.The hot dog blanket was on the patient for the entire procedure.There was no patient injury.

• Brand Name: HOT DOG PATIENT WARMING SYSTEM
• Type of Device: B103 LOWER BODY WARMING 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: 6151857
• MDR Text Key: 61665068
• Report Number: 3005857264-2016-00007
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• PMA/PMN Number: K112488
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: B103
• Device Catalogue Number: B103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2009
• 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 MULTIPORT CONTROLLER, SERIAL NUMBER (B)(4)
• Patient Outcome(s): Other
• Patient Age: 78 YR