BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM THERMOGARD XP

    MDR report key: 6176070 · Received December 15, 2016

    Report

    Report Number
    3010617000-2016-00925
    Event Type
    Malfunction
    Date Received
    December 15, 2016
    Date of Event
    November 14, 2016
    Report Date
    November 23, 2016
    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

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL HAS NOT YET RECEIVED THE ZOLL CONSOLE IN COMPLAINT FOR INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE FILED IF AND WHEN THE PRODUCT IS RETURNED AND INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    ON AN UNSPECIFIED DATE/TIME, A PATIENT WAS TRANSPORTED BY AMBULANCE AFTER SUFFERING FROM ASPHYXIA RESULTING FROM ASPIRATION. ON (B)(6) 2016 AT 3PM, POST-RESUSCITATION BRAIN HYPOTHERMIA THERAPY WAS INITIATED USING THE THERMOGARD XP IVTM SYSTEM (S/N: (B)(4)). THE THERMOGARD CONSOLE WAS SET TO A TARGET TEMPERATURE OF 34°C. THE FOLLOWING DAY ON (B)(6), AT APPROXIMATELY 11:28AM, THE THERMOGARD XP IVTM CONSOLE ALARMED AND DISPLAYED A TCMID: 01 (PUMP FAILED) ERROR MESSAGE. THE ROLLER PUMP HAD FAILED. DESPITE MULTIPLE ATTEMPT TO RESTART THE CONSOLE, THE ISSUE CONTINUED; THE CONSOLE WAS NON-FUNCTIONAL. AT AN UNSPECIFIED TIME LATER, THE PATIENT'S TEMPERATURE MANAGEMENT THERAPY WAS REPLACED WITH THE USE OF A SURFACE COOLING BLANKET. ACCORDING TO THE ATTENDING PHYSICIAN, SINCE THE REWARMING WAS ACHIEVED IN 24 HOURS AFTER THE START OF THE BRAIN HYPOTHERMIA TREATMENT, THERE WAS NO HEALTH INJURY TO THE PATIENT AS A RESULT OF THE REPORTED ISSUE. THE PHYSICIAN HAD DETERMINED THERE WAS NO CONSEQUENCE SWITCHING TEMPERATURE CONTROL MANAGEMENT FROM THE THERMOGARD CONSOLE TO A BLANKET. PER PHYSICIAN, EVEN AFTER THE PATIENT WAS RESUSCITATED, THE PATIENT'S CLINICAL CONDITION WAS EXTREMELY POOR. THE PATIENT EXPIRED ON (B)(6). THE PHYSICIAN, INDICATED THERE WAS NO CAUSAL RELATIONSHIP BETWEEN THE PATIENT'S DEATH AND THE REPORTED THERMOGARD XP IVTM SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829733 ZOLL IVTM THERMOGARD XP THERMAL REGULATING SYSTEM NCX ZOLL CIRCULATION 8700-0650 00849111075022

    Patients

    Seq Age Sex Outcome Treatment
    1