BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM THERMOGARD XP

    MDR report key: 3900942 · Received June 27, 2014

    Report

    Report Number
    3003793491-2014-00304
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    January 2, 2014
    Report Date
    January 3, 2014
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    NCX
    PMA / PMN Number
    K072234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THERMOGARD XP IVTM SYSTEM S/N TGXP11072 WAS EVALUATED AT THE CUSTOMER SITE. THE EVENT LOG WAS REVIEWED. EVALUATION OF THE SYSTEM FOUND THAT THE RAIL WENT TO MAX HEAT ALL THE WAY TO MAX COOL AS INTENDED, ALTHOUGH IT DID TAKE LONGER THAN USUAL, THE READING WERE WITHIN SPECIFICATION. THE CUSTOMER REPORTED COMPLAINT THAT THE PATIENT DID NOT COOL PAST 36 C WAS CONFIRMED THROUGH THE EVENT LOG. THE EVENT LOG SHOWS THAT TREATMENT WAS STOPPED BEFORE THE PATIENT COULD COOL FURTHER. NO REPAIRS WERE MADE TO THE SYSTEM, AS THE SYSTEM WAS FUNCTIONING AS INTENDED. THE SYSTEM UNDERWENT AND PASSED ALL FUNCTIONAL TESTING.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT THE IVTM THERMOGARD SYSTEM DID NOT COOL THE PATIENT. PATIENT TEMPERATURE WAS 36 AND THE TARGET TEMPERATURE WAS 33 DEGREES CELCIUS. THE BIOMED INDICATED THAT THE COOLANT WOULD NOT GO BELOW 18 DEGREES CELCIUS. NO ADVERSE PATIENT SEQUELAE WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED. NO ADVERSE PATIENT SEQUELAE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376929 ZOLL IVTM THERMOGARD XP THERMAL REGULATING SYSTEM NCX ZOLL CIRCULATION, INC 8700-0650

    Patients

    Seq Age Sex Outcome Treatment
    1