BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM THERMOGARD XP

    MDR report key: 17781458 · Received September 20, 2023

    Report

    Report Number
    3010617000-2023-00859
    Event Type
    Malfunction
    Date Received
    September 20, 2023
    Date of Event
    August 25, 2023
    Report Date
    September 20, 2023
    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
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DURING DEVICE INSTALLATION AT THE CUSTOMER SITE, ZOLL DETECTED LOOSE ITEMS IN THE DISPLAY HEAD AND COULD HEAR A RATTLING SOUND FROM THE DISPLAY HEAD OF THE THERMOGARD XP IVTM SYSTEM SN (B)(6). THE DISPLAY HEAD (LOT #182409) WAS RETURNED TO THE ZOLL GERMANY SERVICE DEPOT, AND UPON INSPECTION, NOTED FOUR SCREWS OF 3 BUTTON BOARDS, INCLUDING WASHERS, WERE LOOSE INSIDE THE DISPLAY. THE DISPLAY HEAD WAS REPLACED TO ADDRESS THE OBSERVED ISSUES. NO OTHER PHYSICAL DAMAGES WERE NOTED. UPON FIXING THE SCREWS AND WASHERS, THE RETURNED DISPLAY HEAD (LOT #182409) PASSED ALL THE TESTING AND WAS RETURNED TO ZOLL SERVICE STOCK FOR FUTURE USE. UPON REPLACING THE DISPLAY HEAD, THE THERMOGARD SYSTEM WAS INSTALLED AT THE CUSTOMER SITE, AND THE SYSTEM PASSED ALL THE FUNCTIONAL TESTS WITH NO ISSUES.

    Description of Event or Problem · 0

    DURING UNPACKING OF THE THERMOGARD XP IVTM SYSTEM SN (B)(6) FOR INSTALLATION AT THE CUSTOMER SITE, THE ZOLL TERRITORY MANAGER DETECTED LOOSE ITEMS IN THE DISPLAY HEAD AND COULD HEAR A RATTLING SOUND FROM THE DISPLAY HEAD. ALSO, A WASHER FELL OUT OF THE DISPLAY HEAD. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1614503 ZOLL IVTM THERMOGARD XP THERMAL REGULATING SYSTEM NCX ZOLL CIRCULATION 8700-0650 00849111075022

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown