BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM THERMOGARD XP

    MDR report key: 15126524 · Received July 28, 2022

    Report

    Report Number
    3010617000-2022-00909
    Event Type
    Malfunction
    Date Received
    July 28, 2022
    Date of Event
    June 29, 2022
    Report Date
    July 28, 2022
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075022
    PMA / PMN Number
    K072234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE THERMOGARD XP IVTM SYSTEM (S/N (B)(4) INVOLVED IN THE REPORTED COMPLAINT WAS NOT RETURNED TO ZOLL FOR TECHNICAL INVESTIGATION, AND IT WAS NOT EVALUATED BY A ZOLL SERVICE ENGINEER AT THE CUSTOMER SITE. AS PER THE ZOLL'S REGIONAL MANAGER, THE OVERFLOW OF SALINE INTO THE CONSOLE'S AIR TRAP HOLDER HAD TRIGGERED THE MID:09 ERROR. THE ZOLL'S REGIONAL MANAGER WAS ABLE TO CLEAR THE MID:09 ERROR AT THE CUSTOMER SITE BY CLEANING AND DRYING THE CONSOLE'S AIR TRAP SENSORS. THE THERMOGARD CONSOLE WAS RE-BOOTED AND PASSED POWER-ON-SELF-TEST (POST) WITHOUT ISSUE. THE CONSOLE WAS RELEASED FOR CLINICAL USE.

    Description of Event or Problem · 0

    A PATIENT WHO WAS RESUSCITATED FROM CARDIAC ARREST RECEIVED IVTM THERAPY. THE START-UP KIT (SUK) (LOT # 170892) WAS SUCCESSFULLY PRIMED WITH THE THERMOGARD CONSOLE (S/N (B)(4). DURING THE COOLING PHASE OF THE TREATMENT, THE THERMOGARD SYSTEM GENERATED A MID:09 (AIR TRAP ASSEMBLY) ERROR MESSAGE. THE NURSE REPORTED OBSERVING AIR BUBBLES IN THE SUK TUBING BUT NOT NOTICING A DECREASE IN THE VOLUME OF THE SALINE BAG UNTIL THE MID:09 ERROR OCCURRED. UPON INSPECTION, THE NURSE OBSERVED SALINE ON THE PATIENT'S BED, THE THERMOGARD CONSOLE, AND THE FLOOR. SALINE WAS LEAKING FROM THE AIR TRAP OF THE SUK INTO THE AIR TRAP HOLDER OF THE THERMOGARD CONSOLE. THE DWELL TIME OF THE SUK WAS 2 HOURS WHEN THE ISSUE HAPPENED. BOTH THE SUK AND THERMOGARD CONSOLE WERE IMMEDIATELY REPLACED TO CONTINUE AND COMPLETE THE TREATMENT. NO CONSEQUENCES OR IMPACTS ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1344064 ZOLL IVTM THERMOGARD XP THERMAL REGULATING SYSTEM NCX ZOLL CIRCULATION 8700-0650 00849111075022

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male