BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM THERMOGARD XP

    MDR report key: 3900810 · Received June 27, 2014

    Report

    Report Number
    3003793491-2014-00302
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    December 13, 2013
    Report Date
    December 14, 2013
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    NCX
    PMA / PMN Number
    K072234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THERMOGARD XP IVTM SYSTEM S/N TGXP10308 WAS EVALUATED AT THE CUSTOMER'S LOCATION. A REVIEW OF THE EVENT LOG FOUND NO ANOMALIES. EVALUATION OF THE SYSTEM DID FIND THE COLDWELL MESH TO BE CLOGGED. IN SUMMARY, THE CUSTOMER'S REPORTED COMPLAINT OF THE PATIENT NOT COOLING WAS CONFIRMED THROUGH EVALUATION OF THE SYSTEM. THE COLDWELL MESH WAS UNCLOGGED, REMEDYING THE REPORTED COMPLAINT. THE SYSTEM UNDERWENT AND PASSED ALL FINAL FUNCTIONAL TESTING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE THERMOGARD XP CONSOLE DID NOT COOL THE PATIENT. NO ADVERSE PATIENT SEQUELAE WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378112 ZOLL IVTM THERMOGARD XP THERMAL REGULATING SYSTEM NCX ZOLL CIRCULATION, INC 8700-0650

    Patients

    Seq Age Sex Outcome Treatment
    1