BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INNERCOOL CATHETER

    MDR report key: 3926324 · Received July 1, 2014

    Report

    Report Number
    2032640-2014-00001
    Event Type
    Injury
    Date Received
    July 1, 2014
    Report Date
    June 1, 2014
    Manufacturer
    PHILIPS HEALTHCARE/INNER COOL
    Product Code
    NCX
    PMA / PMN Number
    K033623
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PATIENT EXPERIENCED ARRHYTHMIAS INCLUDING BRADYCARDIA WHILE BEING TREATED WITH THE PHILIPS INNERCOOL RTX SYSTEM. BRADYCARDIA AND OTHER ARRHYTHMIAS ARE RECOGNIZED COMPLICATIONS OF HYPOTHERMIA AND ARE DESCRIBED UNDER THE WARNING SECTION OF THE RTX PRODUCT IFU. AT THE TIME OF THE EVENT, THE PATIENT TEMPERATURE DISPLAYED ON THE RTX CONSOLE WAS 38-40C WITH A TARGET TEMPERATURE OF 36.0C. THE TEMPERATURE SENSOR BEING USED BY THE RTX CONSOLE WAS A 10.7F ACCUTROL CATHETER WHICH WAS PLACED IN THE INFERIOR VENA CAVA. THE PATIENT'S TEMPERATURE WAS ALSO BEING MONITORED BY A SECONDARY INDEPENDENT GE FOLEY/BLADDER TEMPERATURE PROBE CONNECTED TO THE VITAL SIGNS MONITOR IN THE ROOM. THIS DISPLAYED A READING OF 29C AT THE TIME OF THE EVENT. AN ESOPHAGEAL TEMPERATURE SENSOR WAS SUBSTITUTED FOR THE ACCUTROL CATHETER SENSOR AND IT CONFIRMED THAT THE BLADDER TEMPERATURE OF 29C WAS INDEED ACCURATE. THE ESOPHAGEAL TEMPERATURE PROBE WAS USED TO CONTINUE THERAPY WITH THE RTX SYSTEM AND THE PATIENT WAS RETURNED TO THE DESIRED LEVEL OF HYPOTHERMIA. THE PATIENT WAS TREATED FOR BRADYCARDIA AND THERE WERE NO FURTHER SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382617 INNERCOOL CATHETER NCX PHILIPS HEALTHCARE/INNER COOL 989803172301 C13121001

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention GE VITAL SIGNS MONITOR