BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOGARD HQTM CONSOLE

    MDR report key: 24968575 · Received April 23, 2026

    Report

    Report Number
    3010617000-2026-00253
    Event Type
    Malfunction
    Date Received
    April 23, 2026
    Date of Event
    March 30, 2026
    Report Date
    May 20, 2026
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    NCX
    UDI-DI
    00849111075800
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    FOR G4: PMA/510(K): PREMARKET SUBMISSION NUMBER NOT AVAILABLE/NOT RELEASED. THE THERMOGARD HQ CONSOLE IS UNDER INVESTIGATION AT ZOLL. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    B5 (DESCRIBE EVENT OR PROBLEM) WAS UPDATED. DURING THE INCOMING INSPECTION OF THE THERMOGARD HQ CONSOLE (SN (B)(6) AT THE AZM WAREHOUSE, ZOLL TECHNICAL SERVICE PERSONNEL NOTICED THAT ONE OF THE CABLES LABELED P22 (BLUE LINE) HAD BEEN PULLED INSIDE. ALSO, ONE BROWN CABLE (6) LABELED J21 WAS PULLED INSIDE. THE P22 CONNECTOR WAS REPLACED, AND THE WIRING ON THE J21 CONNECTOR WAS SEATED CORRECTLY TO ADDRESS THE OBSERVED PROBLEM. FOLLOWING THE REPLACEMENT, THE THERMOGARD HQ CONSOLE PASSED THE FINAL TEST WITHOUT ISSUE.

    Description of Event or Problem · 0

    DURING THE INCOMING INSPECTION OF THE THERMOGARD HQ CONSOLE (SN (B)(6) AT THE AZM WAREHOUSE, ZOLL TECH SERVICE PERSONNEL NOTICED THAT ONE (BLUE LINE) OF THE CABLES LABELLED P22 WAS PULLED INSIDE. ALSO, ONE (BROWN, 6) OF THE CABLES LABELLED P21 WAS PULLED INSIDE. NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    DURING THE INCOMING INSPECTION OF THE THERMOGARD HQ CONSOLE (SN (B)(6) AT THE AZM WAREHOUSE, ZOLL TECHNICAL SERVICE PERSONNEL NOTICED THAT ONE OF THE CABLES LABELED P22 (BLUE LINE) HAD BEEN PULLED INSIDE. ALSO, ONE BROWN CABLE (6) LABELED J21 WAS PULLED INSIDE. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619661 THERMOGARD HQTM CONSOLE INTRAVASCULAR CORE TEMPERATURE REGULATION SYSTEM NCX ZOLL CIRCULATION, INC. THERMOGARDHQ, LANG SET A 00849111075800

    Patients

    Seq Age Sex Outcome Treatment
    1