BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORTRAK

    MDR report key: 3770608 · Received April 2, 2014

    Report

    Report Number
    3009124963-2014-00008
    Event Type
    Injury
    Date Received
    April 2, 2014
    Date of Event
    February 25, 2014
    Report Date
    April 1, 2014
    Manufacturer
    CORPAK MEDSYSTEMS
    Product Code
    KNT
    PMA / PMN Number
    K091637
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CORTRAK RETURNED WAS EVALUATED AND FOUND TO HAVE NO DEFECT AND FUNCTIONED ACCORDING TO SPECIFICATIONS. 3SW: THE TRACING FROM THE REPORTED PLACEMENT WAS REVIEWED, THE TRACING STARTS AT APPROXIMATELY THE SECOND HASH MARK ABOVE THE HORIZONTAL MIDLINE. THIS WOULD INDICATE THAT THE CORTRAK UNIT WAS STARTED AFTER THE FEEDING TUBE WAS PARTIALLY PLACED OR THAT THE RECEIVER UNIT WAS NOT CORRECTLY PLACED AT THE XIPHOID PROCESS PER THE INSTRUCTIONS. AT APPROXIMATELY 6 SECONDS INTO THE PLACEMENT THE TRACING VEERS TO THE PT'S RIGHT, WHICH IS INDICATIVE OF A RIGHT LUNG PLACEMENT. THE PLACEMENT CONTINUES FOR SEVERAL MINUTES IN THIS AREA WITH NO PULL BACK OF THE FEEDING TUBE NOTED ON THE TRACING. IT IS UNK WHY THE USER DID NOT REACT TO WHAT THE CORTRAK MONITOR WAS SHOWING.

    Description of Event or Problem · 1

    EVENT DESC: CORTRAK ASSISTED NASOGASTRIC TUBE FEEDING INSERTED INTO THE RIGHT LUNG RESULTING A PNEUMOTHORAX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200082 CORTRAK NA KNT CORPAK MEDSYSTEMS 20-0900

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other