BEUDAMED
    FDA Adverse Event Other Summary report: N

    NEOTREND - L SENSOR

    MDR report key: 496340 · Received November 13, 2003

    Report

    Report Number
    9612233-2003-00019
    Event Type
    Other
    Date Received
    November 13, 2003
    Date of Event
    October 1, 2003
    Report Date
    October 17, 2003
    Manufacturer
    DIAMETRICS MEDICAL LTD.
    Product Code
    CCE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    A NEOTREND-L SENSOR WAS PLACED IN A PT. AFTER 5 DAYS IN THE PT A CRACK DEVELOPED IN THE Y-CONNECTOR PRESSURE MONITORING PORT. THERE WAS NO REPORT OF ANY BLOOD OR FLUID LOSS THROUGH THE CRACK. THE SENSOR WAS RETURNED TO THE MFR FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEOTREND - L SENSOR BLOOD GAS MONITORING SYSTEM CCE DIAMETRICS MEDICAL LTD. N7004L 891

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN