BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOLGARD 3000 IVTM SYSTEM

    MDR report key: 3945451 · Received July 21, 2014

    Report

    Report Number
    3003793491-2014-00359
    Event Type
    Malfunction
    Date Received
    July 21, 2014
    Date of Event
    January 6, 2012
    Report Date
    January 12, 2012
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    NCX
    PMA / PMN Number
    K060308
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM WAS EVALUATED ONSITE. PROBABLE CAUSE COULD BE DAMAGE IN THE COOLANT PUMP DUE TO NORMAL WEAR AND TEAR (MANUFACTURING DATE: MARCH 2007). COOLANT PUMP WAS REPLACED AND THE SYSTEM BECAME FUNCTIONAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IVTM COOLGARD SYSTEM DID NOT COOL THE PATIENT. THE FLOW INDICATOR OF THE START-UP KIT (SUK) WAS TURNING. THERE WERE NO ERROR MESSAGES OBSERVED ON THE CONSOLE. THE COOLANT TEMPERATURE WAS WARM AND THE INDICATOR SHOWED MAX COOLING. NO ADVERSE PATIENT SEQUELAE WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425291 COOLGARD 3000 IVTM SYSTEM THERMAL REGULATING SYSTEM NCX ZOLL CIRCULATION, INC 8700-0651

    Patients

    Seq Age Sex Outcome Treatment
    1