BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WARMER, PATIENT, FORCE AIR

    MDR report key: 2182279 · Received July 25, 2011

    Report

    Report Number
    MW5021494
    Event Type
    Malfunction
    Date Received
    July 25, 2011
    Date of Event
    June 29, 2011
    Report Date
    July 11, 2011
    Manufacturer
    ARIZANT HEALTHCARE INC. A 3M CO
    Product Code
    DWJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    HAD SEVERAL OCCURRENCES WHERE THE BAIR HUGGER UNIT OVERHEATED AND SHUT DOWN WHILE IN USE. DEVICES ARE INSTALLED ON A BLUE MOBILE CART FROM (B)(4). THE FRONT OF THE CART IS OPEN TO ALLOW THE USER TO STORE BLANKETS USED WITH THE DEVICE. THE CART'S CAVITY IS ALSO USED BY THE AIR INTAKE (LOCATED ON THE BOTTOM OF THE DEVICE). WHEN THE DEVICE IS MOUNTED ON THE CART, THE AIR INTAKE DRAWS AIR THROUGH THE CAVITY. AFTER EXAMINATION, IT WAS FOUND THAT TOO MANY BLANKETS WERE BEING STORED IN THE CAVITY, RESTRICTING THE FLOW TO THE DEVICE INTAKE. AFTER REMOVING ENOUGH BLANKETS TO OBTAIN AT LEAST A 4" GAP (APPROX) ON ALL OF OUR BAIR HUGGERS, THE OCCURRENCES CEASED. EXAMINATION OF THE UNIT FOUND NO PHYSICAL RESTRICTION TO PREVENT OVER STACKING THE COMPARTMENT NOR ARE THERE ANY LABELS INFORMING THE USER THERE IS A RESTRICTION ON THE NUMBER OF BLANKETS THAT CAN BE SAFELY STORED IN THE BASE. THERE IS ALSO NO MENTION OF THE POTENTIAL OBSTRUCTION IN THE OPERATOR'S GUIDE. THE OPERATOR'S GUIDE ADDRESSES THE USE OF THE FREE STANDING DEVICE OR MOUNTED ON A POLE, NOT THE MOBILE BASE. NOTE: THE AIR INTAKE IS OBSCURED FROM VIEW OF THE OPERATOR WHILE INSTALLED ON THE MOBILE CART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WARMER, PATIENT, FORCE AIR BAIR HUGGER DWJ ARIZANT HEALTHCARE INC. A 3M CO 750

    Patients

    Seq Age Sex Outcome Treatment
    1