BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM THERMOGARD XP

    MDR report key: 3900902 · Received June 27, 2014

    Report

    Report Number
    3003793491-2014-00305
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    January 11, 2014
    Report Date
    January 13, 2014
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    NCX
    PMA / PMN Number
    K072234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THERMOGARD XP IVTM SYSTEM S/N (B)(4) WAS EVALUATED AT THE CUSTOMER SITE. THE EVENT LOG WAS REVIEWED AND FOUND THAT THE SYSTEM WAS CHANGED FROM COOLING MODE TO WARMING MODE AT 6:34 AM. AS THE MODES WERE CHANGED BY THE CUSTOMER, THE CUSTOMER REPORTED COMPLAINT OF THE SYSTEM WARMING WHEN SET IN COOLING MODE CANNOT BE CONFIRMED. THE SYSTEM UNDERWENT AND PASSED ALL FUNCTIONAL TESTING.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT THE IVTM THERMOGARD SYSTEM WAS WARMING WHEN SET FOR COOLING MODE. NO ADVERSE PATIENT SEQUELAE WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376732 ZOLL IVTM THERMOGARD XP THERMAL REGULATING SYSTEM NCX ZOLL CIRCULATION, INC 8700-0650

    Patients

    Seq Age Sex Outcome Treatment
    1