BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOGARD XP IVTM SYSTEM

    MDR report key: 6084561 · Received November 7, 2016

    Report

    Report Number
    3010617000-2016-00793
    Event Type
    Malfunction
    Date Received
    November 7, 2016
    Report Date
    December 20, 2016
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    NCX
    UDI-DI
    00849111075022
    PMA / PMN Number
    K101987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL HAS NOT RECEIVED THE PRODUCT IN COMPLAINT. A SUPPLEMENTAL REPORT WILL BE FILED IF AND WHEN THE PRODUCT IS RETURNED AND INVESTIGATION HAS BEEN PERFORMED.

    Additional Manufacturer Narrative · 1

    THERMOGARD XP IVTM SYSTEM S/N (B)(4) WAS NOT RETURNED TO ZOLL FOR EVALUATION. HOWEVER, THE CONSOLE WAS FUNCTIONALLY TESTED AT CUSTOMER SITE THE REPORTED COMPLAINT WAS CONFIRMED DURING EVENT LOG REVIEW. LM34 TEMPERATURE PROBE WAS REPLACED TO REMEDY THE TCMID: 05 (COOLANT DIFF FAILURE) ERROR MESSAGE. AFTER REPLACING THE PART IDENTIFIED DURING SERVICE, THE THERMOGARD CONSOLE MET ITS PERFORMANCE SPECIFICATIONS OR OTHERWISE PERFORMS AS INTENDED. PERFORMANCE SPECIFICATIONS INCLUDE ALL CLAIMS MADE IN THE LABELING FOR THE DEVICE. HISTORICAL COMPLAINTS WERE REVIEWED FOR SERVICE INFORMATION RELATED TO THE REPORTED COMPLAINT AND THERE WAS NO PREVIOUS HISTORY OF COMPLAINT REPORTED FOR THERMOGARD WITH SERIAL NUMBER (B)(4). CUSTOMER SITE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SERVICE CHECK ON UNSPECIFIED DATE, THE THERMOGARD XP IVTM SYSTEM (SN: (B)(4)) DISPLAYED A TCMID: 05 (COOLANT DIFF FAILURE) ERROR MESSAGE. NO PATIENT INVOLVEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732797 THERMOGARD XP IVTM SYSTEM THERMAL REGULATING SYSTEM NCX ZOLL CIRCULATION, INC 8700-0650 00849111075022

    Patients

    Seq Age Sex Outcome Treatment
    1