BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTRUMENTATION LABORATORY

    MDR report key: 207815 · Received January 27, 1999

    Report

    Report Number
    MW1015515
    Event Type
    Malfunction
    Date Received
    January 27, 1999
    Date of Event
    December 1, 1998
    Report Date
    January 22, 1999
    Manufacturer
    INSTRUMENTATION LABORATORY
    Product Code
    CHL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ERRONEOUS HEMOGLOBIN VALUES REPORTED FROM CO-OXIMETER. CO-OXIMETER FAILES TO MEASURE CLINICALLY ACCEPTABLE HEMOGLOBIN VALUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSTRUMENTATION LABORATORY SYNTHESIS 1725 BLOOD GAS ANALYZER CHL INSTRUMENTATION LABORATORY SYNTHESIS 1725 *
    2 INSTRUMENTATION LABORATORY SYNTHESIS 1725 BLOOD GAS ANALYZER CHL INSTRUMENTATION LABORATORY SYNTHESIS 1725 *
    3 INSTRUMENTATION LABORATORY SYNTHESIS 1725 BLOOD GAS ANALYZER CHL INSTRUMENTATION LABORATORY SYNTHESIS 1725 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *