BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KOOL KIT

    MDR report key: 1734186 · Received June 15, 2010

    Report

    Report Number
    1734186
    Event Type
    Malfunction
    Date Received
    June 15, 2010
    Date of Event
    June 7, 2010
    Report Date
    June 15, 2010
    Manufacturer
    CINCINNATI SUB-ZERO PRODUCTS, INC.
    Product Code
    DWJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US

    Narratives

    Description of Event or Problem · 1

    THE ICU EXPERIENCED SEVERAL EPISODES OF THE HYPOTHERMIA BLANKETS LEAKING. MOST OF THE BLANKETS WERE THE TOP BLANKET SOME WERE BOTTOM BLANKETS. THE LEAK WAS LARGE ON SOME OF THE EPISODES RESULTING IN THE WHOLE BED BEING CHANGED.HEALTH PROFESSIONAL'S IMPRESSION:THE NURSES FEEL IT WAS A DEFECT IN THE BLANKET.MANUFACTURER RESPONSE FOR KIT,HYPOTHERMIA BLANKET, KOOL KIT:MANUFACTURER FELT THIS WAS USER ERROR BUT THERE HAS BEEN NO RHYME OR REASON TO THE BLANKETS SPRINGING A LEAK. IT HAS BEEN THE VEST BOTH TOP AND BOTTOM AS WELL AS THE BLANKET. IT HAS BEEN AT ALL DIFFERENT TIMES, WHEN INITIATING, MIDWAY THROUGH AND AT THE END. BLANKETS SHOULD LAST 68-72 HOURS BUT ARE LASTING ANYWHERE FROM 12-48 HOURS. THE NURSES HAD AN INSERVICE BY THE REP, SO THEY KNOW HOW TO USE THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KOOL KIT HYPOTHERMIA BLANKET DWJ CINCINNATI SUB-ZERO PRODUCTS, INC. * 8614

    Patients

    Seq Age Sex Outcome Treatment
    1 *