BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM THERMOGARD XP

    MDR report key: 6175280 · Received December 15, 2016

    Report

    Report Number
    3010617000-2016-00923
    Event Type
    Malfunction
    Date Received
    December 15, 2016
    Date of Event
    November 22, 2016
    Report Date
    December 14, 2016
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075022
    PMA / PMN Number
    K072234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE THERMOGARD XP IVTM (S/N: (B)(4)) WAS EVALUATED BY ZOLL'S SERVICE TECHNICIAN AT THE CUSTOMER SITE. THE PRIMARY COMPLAINT WAS CONFIRMED DURING EVALUATION. FURTHER INVESTIGATION FOUND COOLANT IN THE SENSOR HOLES OF THE AIR TRAP BLOCK. THE CUSTOMER ISSUE WAS RESOLVED AFTER THE SENSOR HOLES WERE DRIED. VISUAL INSPECTION WAS PERFORMED AND NO PHYSICAL DAMAGE WAS FOUND. NO IRREGULARITIES WERE FOUND DURING REVIEW OF THE EVENT LOG FILES. FUNCTIONAL TESTING WAS PERFORMED AND NO FAULTS WERE FOUND. DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR SERVICE INFORMATION RELATED TO THE REPORTED COMPLAINT AND THERE WAS NO PREVIOUS HISTORY OF COMPLAINT REPORTED FOR THERMOGARD XP IVTM (S/N: (B)(4)). THE CONSOLE PASSED ALL TESTING CRITERIA AND WAS WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE THERMOGARD XP IVTM (S/N: (B)(4)) CONSOLE DOES NOT DISPLAY THE STANDBY DISPLAY SCREEN, BECAUSE THE CONSOLE DOES NOT ACCEPT THE AIR TRAP IN THE "SYSTEM SET UP SCREEN". ACCORDING TO THE REPORTER, THE AIR TRAP INDICATES RED ON THE DISPLAY HEAD; HOWEVER, THE AIR TRAP IS COMPLETELY FILLED. DESPITE RESTARTING THE CONSOLE SEVERAL TIME, THE ISSUE CONTINUED. A SECONDARY THERMOGARD XP IVTM WAS USED TO CONTINUE AND COMPLETE PATIENT'S TEMPERATURE MANAGEMENT THERAPY. NO KNOWN PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    825745 ZOLL IVTM THERMOGARD XP THERMAL REGULATING SYSTEM NCX ZOLL CIRCULATION 8700-0650 00849111075022

    Patients

    Seq Age Sex Outcome Treatment
    1