BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM THERMOGARD XP

    MDR report key: 6126493 · Received November 23, 2016

    Report

    Report Number
    3010617000-2016-00838
    Event Type
    Malfunction
    Date Received
    November 23, 2016
    Report Date
    November 23, 2016
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075022
    PMA / PMN Number
    K072234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERMOGARD XP IVTM SYSTEM (S/N# (B)(4)) WAS SERVICED AT CUSTOMER SITE. HISTORICAL COMPLAINTS WERE REVIEWED FOR SERVICE INFORMATION RELATED TO THE REPORTED COMPLAINT AND THERE WAS NO PREVIOUS HISTORY OF COMPLAINT REPORTED FOR THERMOGARD XP IVTM SYSTEM S/N: (B)(4). A VISUAL INSPECTION WAS PERFORMED AND DRIP TRAY WAS MISSING (UNRELATED TO THE REPORTED COMPLAINT). A REVIEW OF THE EVENT LOG WAS PERFORMED AND FOUND NO ERRORS OR ANOMALIES. DURING FUNCTIONAL TESTING, ERROR MESSAGE TCMID: 02 (COOLING ENGINE DANFOSS ERROR) WAS NOTED, THUS CONFIRMING THE REPORTED COMPLAINT. IN SUMMARY, THE CUSTOMER'S REPORT OF THE THERMOGARD DISPLAYING TCMID:02 (COOLING ENGINE DANFOSS ERROR) WAS CONFIRMED DURING FUNCTIONAL TESTING. THE SYSTEM SOFTWARE WAS UPDATED. THE PIC16 BOARD AND DAN FOSS CONTROLLER WERE UPDATED TO RESOLVE THE PROBLEM. THE SYSTEM WAS CALIBRATED AND TESTED. THE CONSOLE PASSED FINAL FUNCTIONAL TEST WITH NO FURTHER ISSUE. THE THERMOGARD XP IVTM SYSTEM IS A REUSABLE DEVICE AND WAS MANUFACTURED IN 06/22/2010. THE DAMAGE FOUND IS A NORMAL WEAR AND TEAR FOR THE LIFE OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PATIENT USE THE THERMOGARD XP IVTM SYSTEM (SN: (B)(4)) WAS DISPLAYING ERROR MESSAGE TCMID:02 (CE DANFOSS ERROR). THE CUSTOMER WAS ABLE TO CONTINUE AND COMPLETE THEIR TEMPERATURE MANAGEMENT THERAPY USING ANOTHER SYSTEM. THERE WERE NO REPORTS OF PATIENT CONSEQUENCES. PROBLEM OCCUR DATE IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775729 ZOLL IVTM THERMOGARD XP THERMAL REGULATING SYSTEM NCX ZOLL CIRCULATION 8700-0650 00849111075022

    Patients

    Seq Age Sex Outcome Treatment
    1