BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM THERMOGARD XP

    MDR report key: 6018574 · Received October 11, 2016

    Report

    Report Number
    3010617000-2016-00710
    Event Type
    Malfunction
    Date Received
    October 11, 2016
    Date of Event
    September 14, 2016
    Report Date
    October 11, 2016
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075022
    PMA / PMN Number
    K072234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERMOGARD XP IVTM SYSTEM S/N: (B)(4) WAS SERVICED AT CUSTOMER'S SITE. HISTORICAL COMPLAINTS WERE REVIEWED FOR SERVICE INFORMATION RELATED TO THE REPORTED COMPLAINT AND CCR 18191 WAS REPORTED ON (B)(6) 2014 FOR THERMOGARD XP IV SYSTEM WITH SERIAL NUMBER (B)(4) FOR THE SAME POWER FAILURE ISSUE. FUNCTIONAL TESTING WAS PERFORMED AND THE FUSE WAS FOUND TO BE FAULTY. AFTER REPLACING THE FUSE TO REMEDY THE REPORTED COMPLAINT, THE SYSTEM WAS TESTED AND PASSED ALL FINAL FUNCTIONAL TESTING CRITERIA. IN SUMMARY THE CUSTOMER'S REPORTED COMPLAINT WAS CONFIRMED DURING FUNCTIONAL TESTING. THE ROOT CAUSE WAS DETERMINED TO BE A FAULTY FUSE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE THERMOGARD XP IVTM SYSTEM (S/N: (B)(4) HAD NO POWER DURING SETUP. ANOTHER SYSTEM WAS USED TO TREAT PATIENT. HOWEVER, THE BIOMED REPLACED A FUSE AND TESTED THE SYSTEM OVER 24 HOURS. THERE WERE NO PATIENT SEQUAELA REPORTED .NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667850 ZOLL IVTM THERMOGARD XP THERMAL REGULATING SYSTEM NCX ZOLL CIRCULATION 8700-0650 00849111075022

    Patients

    Seq Age Sex Outcome Treatment
    1