BEUDAMED
    FDA Adverse Event Other Summary report: N

    NEOTREND-L SENSOR

    MDR report key: 448486 · Received March 12, 2003

    Report

    Report Number
    9612233-2003-00005
    Event Type
    Other
    Date Received
    March 12, 2003
    Date of Event
    January 1, 2003
    Report Date
    February 13, 2003
    Manufacturer
    DIAMETRICS MEDICAL, LTD.
    Product Code
    CCW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE NEOTREND-L SENSOR WOULD NOT ADVANCE COMPLETELY INTO A 5.0 FR VAC. IT STOPPED MOVING FORWARD AFTER A SMALL DISTANCE. BLOOD THEN BACKED UP INTP THE SENSOR AND INTO THE CONNECTOR OF THE PT DATA MODULE. THE SENSOR HAS BEEN RETURNED TO THE MFR FOR INVESTIGATION. NO REPORT OF ANY INJURY OR HARM TO THE PT HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEOTREND-L SENSOR BLOOD GAS MONITORING SYSTEM CCW DIAMETRICS MEDICAL, LTD. N7004 L 872

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN