BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLAR CARE

    MDR report key: 1615994 · Received February 23, 2010

    Report

    Report Number
    1615994
    Event Type
    Malfunction
    Date Received
    February 23, 2010
    Date of Event
    February 15, 2010
    Report Date
    February 23, 2010
    Manufacturer
    BREG INC.
    Product Code
    ILO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WE ARE REPORTING TWO EVENTS IN THIS ONE REPORT. A NURSE APPLIED A POLAR CARE UNIT FOR COOLING THERAPY TO THE PATIENT'S KNEE. THE DEVICE WAS SET UP ACCORDING TO THE MANUFACTURER'S INSTRUCTIONS AND PLUGGED INTO AN ELECTRICAL OUTLET. HOWEVER, LESS THAN 30 MINUTES LATER, THE PATIENT CALLED THE NURSE TO REPORT THAT THE UNIT WAS TURNING OFF AND ON INDEPENDENTLY. THE RN CHECKED THE SYSTEM AND COULD NOT FIND ANY OBVIOUS DEFECTS. ENGINEERING CHECKED THE ELECTRICAL OUTLET AND COULD FIND NOTHING WRONG WITH IT. THE DEVICE WAS REMOVED AND A NEW ONE WAS OBTAINED, WHICH WORKED FINE. THE SECOND EVENT IS NEARLY IDENTICAL EXCEPT THAT THE POLAR CARE UNIT BEGAN TO TURN ITSELF OFF AND ON ALMOST IMMEDIATELY AFTER THE NURSE PLUGGED IT INTO THE ELECTRICAL OUTLET. STAFF ARE CONCERNED THAT THERE MAY BE A SHORT IN THE ELECTRICAL SYSTEM INSIDE THE DEVICE THAT THEY CANNOT SEE. NO PATIENTS OR STAFF WERE HARMED IN EITHER EVENT. THERE ARE TWO DIFFERENT LOT NUMBERS FOR THESE PRODUCTS: 29957805 AND 29960241. BOTH ARE THE SAME MODEL NUMBER (PC 300).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLAR CARE PACK, HOT OR COLD, WATER CIRCULATING ILO BREG INC. PC 300 29957805

    Patients

    Seq Age Sex Outcome Treatment
    1 *