BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3M BAIR HUGGER

    MDR report key: 5652275 · Received May 13, 2016

    Report

    Report Number
    5652275
    Event Type
    Malfunction
    Date Received
    May 13, 2016
    Date of Event
    April 20, 2016
    Report Date
    May 5, 2016
    Manufacturer
    ARIZANT/3M
    Product Code
    DWJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING ROBOTIC LAPAROSCOPIC NISSEN FUNDOPLICATION PROCEDURE, A STRONG SMELL OF SOMETHING BURNING WAS NOTICED NEAR THE BAIR HUGGER AT THE FOOT OF THE OPERATING ROOM TABLE. THE SMELL DISAPPEARED AFTER THE BAIR HUGGER MACHINE WAS TURNED OFF. THE BAIR HUGGER SHEET (LOWER SHEET BEING USED FOR THE PATIENT) WAS REMOVED AND INSPECTED. DARK HOLE MARKS WAS OBSERVED. THE HOSPITAL BLANKET THAT WAS PLACED UNDER THE BAIR HUGGER SHEET WAS INSPECTED AND FOUND TO BE INTACT. THE PATIENT'S SKIN WAS INSPECTED AND FOUND TO BE INTACT. THE MACHINE, BAIR HUGGER SHEET, AND BAIR HUGGER MACHINE WAS IMMEDIATELY REMOVED AND PICKED UP BY BIOENGINEERING. THE MACHINE WAS INSPECTED. DURING INSPECTION THE BURNING SMELL WAS REPRODUCED. THE ARIZANT TECH SUPPORT REP WAS NOTIFIED. THE BAIR HUGGER MACHINE IS CURRENTLY WITH BIOENGINEERING AWAITING PICKUP AND REPLACEMENT BY ARIZANT. TECHNICAL SUPPORT SERVICES REP FOR 3M HEALTH CARE BUSINESS HAS BEEN MADE AWARE OF THIS EVENT. ONCE A NEW MACHINE IS AVAILABLE FOR DELIVERY, IT WILL BE REPLACED AND THE MACHINE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308336 3M BAIR HUGGER SYSTEM, THERMAL REGULATING DWJ ARIZANT/3M

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR NONE REPORTED DURING INVESTIGATION.