BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM THERMOGARD XP

    MDR report key: 15071176 · Received July 20, 2022

    Report

    Report Number
    3010617000-2022-00816
    Event Type
    Malfunction
    Date Received
    July 20, 2022
    Date of Event
    June 17, 2022
    Report Date
    July 20, 2022
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075022
    PMA / PMN Number
    K072234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE THERMOGARD XP IVTM SYSTEM (SN UNKNOWN) INVOLVED IN THE REPORTED COMPLAINT WILL NOT BE RETURNED TO A ZOLL SERVICE DEPOT FOR EVALUATION BECAUSE THE CUSTOMER RESOLVED THE ISSUE BY MANUALLY CLEANING AND DRYING THE CONSOLE. THE CONSOLE WAS TESTED AND IS FUNCTIONING AS INTENDED. THE THERMOGARD SYSTEM WAS PLACED BACK INTO SERVICE FOR CLINICAL USE. THEREFORE, SERVICE WAS NOT REQUIRED TO BE PERFORMED BY ZOLL.

    Description of Event or Problem · 0

    DURING THE NIGHTSHIFT OF JUNE 16TH, IVTM THERAPY BEGAN. AFTER APPROXIMATELY 12 HOURS OF THERAPY, THE THERMOGARD XP IVTM SYSTEM (SN UNKNOWN) DISPLAYED AN AIR TRAP ALARM, THE SALINE BAG WAS ASSESSED AND WAS FOUND TO BE EMPTY. THE STAFF CHANGED THE SALINE BAG. WHEN THEY NOTED THE SECOND SALINE BAG WAS GOING EMPTY, THEY STOPPED THE THERAPY AND OPENED THE LID TO FIND SALINE ALL OVER AIR TRAP AND LID. THE START-UP KIT (SUK) (LOT #UNKNOWN) HAD A LEAK AT THE AIR TRAP AND WAS REPLACED. THERAPY WAS RESTARTED WITH A SECOND THERMOGARD XP IVTM SYSTEM (SN (B)(4) BECAUSE OF FLUID OBSERVED IN THE FIRST CONSOLE. HOWEVER, THE AIR TRAP ALARM IN THE FIRST CONSOLE WAS CLEARED. DURING THERAPY, STAFF RECEIVED ANOTHER AIR TRAP ALARM AND FOUND SALINE EVERYWHERE AND THE BOTTOM CAP ON THE AIR TRAP OF THE SECOND SUK (LOT #173379) WAS DETACHED. THIS WILL BE THE SUK THAT WILL BE RETURNING. A THIRD SUK AND CONSOLE WAS OBTAINED. THE SECOND CONSOLE ALSO HAD FLUID INSIDE THE MACHINE BUT THE AIR TRAP ALARM WAS ALSO CLEARED. THERAPY WAS COMPLETED ON 6/20. NO IMPACT OR CONSEQUENCE TO PATIENT. PLEASE SEE THE FOLLOWING RELATED MFR REPORT: MFR # (B)(4) FOR THE THERMOGARD XP IVTM SYSTEM B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1699685 ZOLL IVTM THERMOGARD XP THERMAL REGULATING SYSTEM NCX ZOLL CIRCULATION 8700-0650 00849111075022

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown