BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM THERMOGARD XP

    MDR report key: 13585710 · Received February 23, 2022

    Report

    Report Number
    3010617000-2022-00181
    Event Type
    Malfunction
    Date Received
    February 23, 2022
    Date of Event
    February 2, 2022
    Report Date
    February 23, 2022
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075022
    PMA / PMN Number
    K072234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    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.

    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 THE REWARMING PHASE OF IVTM THERAPY, A HOSPITAL NURSE NOTICED THE THERMOGARD IVTM SYSTEM (SN (B)(4)) TO BE "EXCESSIVELY" WARMER MORE THAN NORMAL (TEMPERATURE WAS AT 34°C/ 93.2°F). FOLLOWING THIS, THE THERMOGARD IVTM SYSTEM GENERATED AN ALARM AND IT MADE A LOUD NOISE AND THEN IT STOPPED WORKING. PER REPORTER, THE START-UP KIT (LOT #163424) HAD LEAK AND SALINE FLUID POUR OUT INTO THERMOGARD IVTM SYSTEM. THE SUK AND ANOTHER THERMOGARD IVTM SYSTEM WAS USED TO COMPLETE THE TREATMENT WITHOUT ANY ISSUE. THE CATHETER WAS INSERTED INTO THE PATIENT RIGHT FEMORAL VEIN. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

    Description of Event or Problem · 0

    DURING THE REWARMING PHASE OF IVTM THERAPY, A HOSPITAL NURSE NOTICED THE THERMOGARD IVTM SYSTEM (SN (B)(4)) TO BE "EXCESSIVELY" WARMER MORE THAN NORMAL (TEMPERATURE WAS AT 34°C/ 93.2°F). FOLLOWING THIS, THE THERMOGARD IVTM SYSTEM GENERATED AN ALARM AND IT MADE A LOUD NOISE AND THEN IT STOPPED WORKING. PER REPORTER, THE START-UP KIT (LOT #163424) HAD LEAK AND SALINE FLUID POUR OUT INTO THERMOGARD IVTM SYSTEM. THE SUK AND ANOTHER THERMOGARD IVTM SYSTEM WAS USED TO COMPLETE THE TREATMENT WITHOUT ANY ISSUE. THE CATHETER WAS INSERTED INTO THE PATIENT RIGHT FEMORAL VEIN. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    930584 ZOLL IVTM THERMOGARD XP THERMAL REGULATING SYSTEM NCX ZOLL CIRCULATION 8700-0650 00849111075022

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male