BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DONJOY ICEMAN COOLER

    MDR report key: 1053213 · Received May 20, 2008

    Report

    Report Number
    1053213
    Event Type
    Malfunction
    Date Received
    May 20, 2008
    Date of Event
    April 20, 2008
    Report Date
    May 20, 2008
    Manufacturer
    DJO, LLC
    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

    STAFF REPORT THAT THEY WERE APPLYING THE COOLING UNIT AT THE END OF THE SURGICAL CASE. WHEN THEY TURNED THE UNIT ON, IT BEGAN LEAKING FROM THE POINT WHERE THE BLUE TUBING EXITS THE MAIN COOLING UNIT. STAFF WERE CONCERNED THAT IT COULD HAVE CONTAMINATED THE FRESH SURGICAL SITE. THEY ALSO REPORT THAT THEY HAVE HAD THE SAME PROBLEM WITH THIS DEVICE IN THE PAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DONJOY ICEMAN COOLER COLD THERAPY UNIT ILO DJO, LLC 1100 112907-01B

    Patients

    Seq Age Sex Outcome Treatment
    1 *