BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM THERMOGARD XP

    MDR report key: 6038859 · Received October 19, 2016

    Report

    Report Number
    3010617000-2016-00763
    Event Type
    Malfunction
    Date Received
    October 19, 2016
    Date of Event
    October 5, 2016
    Report Date
    December 20, 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
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL HAS NOT YET RECEIVED THE THERMOGARD IN COMPLAINT FOR INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE FILLED IF AND WHEN THE PRODUCT IS RETURNED AND INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THERMOGARD XP IVTM SYSTEM S/N (B)(4) WAS RETURNED TO ZOLL FOR EVALUATION. THE REPORTED COMPLAINT OF THE CONSOLE NOT RECOGNIZING THE AIRTRAP WAS NOT CONFIRMED DURING FUNCTIONAL TESTING. THE CONSOLE WAS FUNCTIONALLY TESTED AND THE REPORTED COMPLAINT COULD NOT BE REPLICATED. THE PROBABLE ROOT CAUSE IS DROP OF LIQUID IN ONE OF THE SENSOR TUNNELS WHICH DRIED UP OVER TIME. THE CONSOLE EVENT LOG WAS REVIEWED AND FOUND AIRTRAP IRREGULARITIES ON 10/5/2016. PREVENTATIVE MAINTENANCE WAS PERFORMED AND THE CONSOLE PASSED ALL TESTS CRITERIA. HISTORICAL COMPLAINTS WERE REVIEWED FOR SERVICE INFORMATION RELATED TO THE REPORTED COMPLAINT AND THERE WAS NO PREVIOUS HISTORY OF COMPLAINT REPORTED FOR AUTOPULSE WITH SERIAL NUMBER (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM DID NOT RECOGNIZE THE AIRTRAP AFTER THE SUK WAS EXCHANGED. THE SENSOR HOLES WERE CLEARED. NO INFORMATION IS AVAILABLE ON THE OUTCOME OF THE PATIENT OR HOW THE THERAPY WAS CONTINUED AFTER THE SYSTEM FAILURE. THIS ISSUE OCCURED DURING POWERING ON THE DEVICE. NO PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690106 ZOLL IVTM THERMOGARD XP THERMAL REGULATING SYSTEM NCX ZOLL CIRCULATION 8700-0650 00849111075022

    Patients

    Seq Age Sex Outcome Treatment
    1