BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOT DOG MULTI-POSITION WARMING BLANKET

    MDR report key: 3963713 · Received July 2, 2014

    Report

    Report Number
    3005857264-2014-00001
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    May 28, 2014
    Report Date
    June 27, 2014
    Manufacturer
    AUGUSTINE BIOMEDICAL & DESIGN, LLC DBA AUGUSTINE TEMPERATURE MANAGEMENT
    Product Code
    DWJ
    PMA / PMN Number
    K5052392
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS DISSECTED FOR EVALUATION. AN ELECTRIC WIRE WAS OBSERVED BEYOND THE STANDARD SPLICE CRIMP COMPONENT, WAS BENT, AND A SINGLE STRAND WAS OBSERVED TO HAVE PENETRATED THE WIRE INSULATION, CONDUCTING ELECTRIC CURRENT TO THE INNER COMPONENTS OF THE WARMING BLANKET. THE CRIMP COMPONENT DID NOT COVER THE EXTERNAL ENDS OF THE WIRE AT THE SPLICE AND ATYPICAL OF ELECTRICAL STANDARD OF WORK. WE HAVE BEEN UNABLE TO GET A CURRENT CONDITION OF THE PATIENT RELATIVE TO WHETHER THE REDDENING RESOLVED QUICKLY OR WHETHER IT WAS CONSIDERED A FIRST DEGREE BURN. WE WILL CONTINUE TO MONITOR AND UPDATE AS APPROPRIATE.

    Description of Event or Problem · 1

    THE ABDOMINOPLASTY PATIENT WAS BEING WARMED USING A B105 MULTI-POSITION WARMING BLANKET, SN (B)(4), SET TO DELIVER 43 DEGREES CELSIUS PER THE REQUEST OF THE ANESTHETIST. THE HOSPITAL REPORTED THE WARMING BLANKET MALFUNCTIONED, BURNING A HOLE THROUGH A STANDARD HOSPITAL BLANKET WHICH WAS DOUBLED UP AND POSITIONED BETWEEN THE PATIENT'S LEGS AND THE WARMING BLANKET, CAUSING A REDDENED AREA ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385295 HOT DOG MULTI-POSITION WARMING BLANKET HOT DOG MULTI-POSITION WARMING BLANKET DWJ AUGUSTINE BIOMEDICAL & DESIGN, LLC DBA AUGUSTINE TEMPERATURE MANAGEMENT B105 0903192

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention