BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM THERMOGARD XP

    MDR report key: 15811788 · Received November 17, 2022

    Report

    Report Number
    3010617000-2022-02022
    Event Type
    Malfunction
    Date Received
    November 17, 2022
    Date of Event
    October 15, 2022
    Report Date
    November 16, 2022
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075022
    PMA / PMN Number
    K072234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZOLL HAS NOT RECEIVED THE PRODUCT FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE PRODUCT IS RETURNED AND INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 0

    DURING IVTM THERAPY, CUSTOMER NOTICED THE THERMOGARD IVTM SYSTEM GENERATED AN "AIR TRAP" WARNING ALARM. LEAK CHECK WAS PERFORMED BUT UNKNOWN IF SALINE WAS NOTICED ON THE FLOOR, PATIENT'S BED OR THERMOGARD CONSOLE. THE CUSTOMER DISCONNECTED THE ICY CATHETER (LOT #162799) AND FLUSHED IT WITH SYRINGE AND OBSERVED NO FLUID RETURNED. A POTENTIAL LEAK ON THE ICY CATHETER WAS SUSPECTED BY THE CUSTOMER AND IT WAS REMOVED. A NEW CATHETER WAS INSERTED TO CONTINUE WITH TREATMENT. IT IS UNKNOWN IF THE "AIR TRAP" WARNING ALARM WAS CLEARED AND IT WAS USED TO CONTINUE WITH TREATMENT. CATHETER DWELL TIME IS UNKNOWN. NO CONSEQUENCES OR IMPACT TO THE PATIENT. PLEASE SEE THE FOLLOWING RELATED MFR REPORT: MFR (B)(4) FOR THE ICY CATHETER (LOT #162799).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1859947 ZOLL IVTM THERMOGARD XP THERMAL REGULATING SYSTEM NCX ZOLL CIRCULATION 8700-0650 00849111075022

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown