BEUDAMED
    FDA Adverse Event Other Summary report: N

    PARATREND 7 FL SENSOR

    MDR report key: 384117 · Received March 19, 2002

    Report

    Report Number
    9612233-2002-00003
    Event Type
    Other
    Date Received
    March 19, 2002
    Date of Event
    February 19, 2002
    Report Date
    February 21, 2002
    Manufacturer
    DIAMETRICS MEDICAL LTD
    Product Code
    CCE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AFTER A SUCCESSFUL CALIBRATION AND INSERTION ON THE PATIENT, AND APPROXIMATELY 47 HOURS OF USE, THE TRENDCARE MONITOR DISPLAYED A "VERIFY CONNECTION" MESSAGE AND STOPPED DISPLAYING MEASUREMENTS. WHEN THE SENSOR WAS DISCONNECTED FROM THE PATIENT DATA MODULE, A LARGE AMOUNT OF BLOOD WAS FOUND INSIDE THE CONNECTOR. THE SENSOR WAS RETURNED TO DIAMETRICS MEDICAL LIMITED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARATREND 7 FL SENSOR BLOOD GAS MONITORING SYSTEM CCE DIAMETRICS MEDICAL LTD MPS 7004S 828

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN