BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOGARD XP®

    MDR report key: 23351950 · Received October 21, 2025

    Report

    Report Number
    3010617000-2025-00729
    Event Type
    Malfunction
    Date Received
    October 21, 2025
    Date of Event
    September 27, 2025
    Report Date
    October 21, 2025
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    NCX
    UDI-DI
    00849111075022
    PMA / PMN Number
    K072234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE THERMOGARD XP IVTM SYSTEM INVOLVED IN THE REPORTED COMPLAINT WILL NOT BE RETURNED FOR EVALUATION. THE AZM SALES REPRESENTATIVE VISITED THE CUSTOMER'S FACILITY AND REPLACED THE FUSE TO ADDRESS THE REPORTED COMPLAINT. AFTER PART REPLACEMENT, THE THERMOGARD SYSTEM WAS USED TO CONTINUE THE IVTM THERAPY WITHOUT ISSUES. ZOLL SERVICE WAS NOT REQUESTED. HISTORICAL COMPLAINTS WERE REVIEWED FOR SERVICE INFORMATION RELATED TO THE REPORTED COMPLAINT, AND THERE WAS NO PREVIOUS HISTORY OF COMPLAINTS REPORTED FOR THE THERMOGARD XP IVTM SYSTEM WITH SN (B)(6).

    Description of Event or Problem · 0

    ON SEPTEMBER 25, AN IVTM THERAPY WAS INITIATED USING THE THERMOGARD XP IVTM SYSTEM (SN (B)(6) WITH AN ICY CATHETER. ON SEPTEMBER 27, AT 02:00, THE NURSE NOTICED THAT THE SYSTEM'S POWER WAS OFF WHILE MAKING ROUNDS. AT 03:00, THE MEDICAL ENGINEER AND THE NURSE CHECKED THE SYSTEM, AND IT WAS HIGHLY LIKELY THAT THE FUSE HAD BLOWN. AT 04:00, THE AZM SALES REPRESENTATIVE VISITED THE CUSTOMER'S FACILITY, REPLACED THE FUSE, AND TURNED THE SYSTEM BACK ON. THE PATIENT'S TEMPERATURE WAS 36.9°C, ABOVE THE TARGET TEMPERATURE OF 35.9°C, CONFIRMING THAT THE SYSTEM PROPERLY CONTINUED THE THERAPY. NO PATIENT INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226958 THERMOGARD XP® INTRAVASCULAR CORE TEMPERATURE REGULATION SYSTEM NCX ZOLL CIRCULATION, INC. THERMOGARD XP, LANG SET A, NON-ROHS 00849111075022

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown