BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM THERMOGARD XP

    MDR report key: 7947065 · Received October 9, 2018

    Report

    Report Number
    3010617000-2018-01017
    Event Type
    Malfunction
    Date Received
    October 9, 2018
    Date of Event
    September 17, 2018
    Report Date
    October 9, 2018
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075022
    PMA / PMN Number
    K072234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT ON THE THERMOGARD CONSOLE (SN (B)(4)) WAS CONFIRMED DURING FUNCTIONAL TESTING AND NOT CONFIRMED ON THE ANALYSIS OF THE EVENT LOG. THE ROOT CAUSE WAS DUE TO CUSTOMER USING THE WRONG FUSE ON THE CONSOLE. DURING INITIAL FUNCTIONAL TESTING, THE CONSOLE DID NOT POWER ON. IT WAS OBSERVED THAT 1A FUSE WAS USED ON THE CONSOLE. THE CORRECT FUSE FOR THE CONSOLE IS 6.3A. UPON VISUAL INSPECTION, THE COLD WELL CAP AND HEX BASKET WERE MISSING, AND THE WHITE ROLLER AND PUMP LID WERE DAMAGED. THESE OBSERVATIONS ARE NOT RELATED TO THE REPORTED COMPLAINT. DURING ANALYSIS OF THE EVENT LOG, NO ISSUES WERE OBSERVED. AFTER REPLACING THE FUSE, WHITE ROLLER, PUMP LID, COLD WELL CAP AND HEX BASKET; THE CONSOLE WAS FURTHER TESTED TO FULL SPECIFICATION. HISTORICAL COMPLAINTS WERE REVIEWED FOR SERVICE INFORMATION RELATED TO THE REPORTED COMPLAINT AND THERE WAS NO PREVIOUS HISTORY OF COMPLAINT REPORTED FOR THE THERMOGARD CONSOLE WITH SERIAL NUMBER (B)(4).

    Description of Event or Problem · 1

    DURING SYSTEM CHECK, AFTER A FEW MINUTES OF OPERATION, THE THERMOGARD CONSOLE (SN (B)(4)) HAD BLOWN A FUSE. FOLLOWING THIS, THE USER REPLACED THE FUSE AND THE ISSUE PERSISTED. BIOMED SUSPECTED POWER SUPPLY FAILURE. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787197 ZOLL IVTM THERMOGARD XP THERMAL REGULATING SYSTEM NCX ZOLL CIRCULATION 8700-0650 00849111075022

    Patients

    Seq Age Sex Outcome Treatment
    1