BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM THERMOGARD XP

    MDR report key: 11427180 · Received March 7, 2021

    Report

    Report Number
    3010617000-2021-00256
    Event Type
    Malfunction
    Date Received
    March 7, 2021
    Date of Event
    February 7, 2021
    Report Date
    March 5, 2021
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075022
    PMA / PMN Number
    K072234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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 · 1

    DURING IVTM THERAPY FOR A PATIENT WITH SUBARACHNOID HEMORRHAGE, CUSTOMER NOTICED THE THERMOGARD SYSTEM DISPLAYED AN "CIRCULATION ERROR" AND OBSERVED BLOOD IN THE START-UP KIT (LOT #145889). PER REPORTER, THE BALLOON ON THE COOL LINE CATHETER (LOT #150061) WAS DAMAGED. IVTM THERAPY WAS DISCONTINUED. NO CONSEQUENCES OR IMPACT TO PATIENT. PLEASE SEE THE FOLLOWING RELATED MFR REPORT: MFR # 3010617000-2021-00206 FOR THE COOL LINE CATHETER (LOT #150061).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324642 ZOLL IVTM THERMOGARD XP THERMAL REGULATING SYSTEM NCX ZOLL CIRCULATION 8700-0650 00849111075022

    Patients

    Seq Age Sex Outcome Treatment
    1