MAUDE Adverse Event Report: AUGUSTINE BIOMEDICAL & DESIGN, LLC, DBA HOT DOG PATIENT WARMING SYSTEM; B105 MULTI POSITION WARMING BLANKET

Model Number B105

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Company rec'd an email on (b)(6) 2015 alleging a product malfunction/deterioration.A (b)(6) 2015 conference call confirmed there was no pt injury or consequence for this incident, and return of product was requested.

Manufacturer Narrative

The returned warming blanket was rec'd (b)(6) 2015 and evaluated to current specifications.Observations included heater fabric with signs of abrasion and extreme wrinkling of the buss.As a result, it is hypothesized that the silver conductive thread that connects the buss to the heater fabric was no longer making good contact.This caused localized heating and damage of the heater fabric, preventing electrical conductivity, and caused adjacent areas to carry more current.This situation created small and localized overheated areas along the edge of the blanket.Company requested add'l info on (b)(6) 2015 via a supplementary incident disclosure form for the hosp to document specifics around device use, observations, etc.To date, including 2 follow-ups, no add'l info has been provided.

• Brand Name: HOT DOG PATIENT WARMING SYSTEM
• Type of Device: B105 MULTI POSITION WARMING BLANKET
• Manufacturer (Section D): AUGUSTINE BIOMEDICAL & DESIGN, LLC, DBA; 6581 city west parkway; augustine temperature mgt; eden prairie MN 55344
• Manufacturer Contact: jasper blake, dir, qa&ra ; 6581 city west parkway; eden prairie, MN 55344 ; 9524653500
• MDR Report Key: 4819011
• MDR Text Key: 5925527
• Report Number: 3005857264-2015-00005
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K112488
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 05/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B105
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/07/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2012
• 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