BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNTHESIS

    MDR report key: 233575 · Received July 23, 1999

    Report

    Report Number
    8020992-1999-00001
    Event Type
    Malfunction
    Date Received
    July 23, 1999
    Date of Event
    June 26, 1999
    Report Date
    July 23, 1999
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Product Code
    JKS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT AN ADULT MALE PATIENT WAS HOSPITALIZED FOR SUSPECTED CO POISONING WITH A COHB. READING OF 22.8% ON THEIR IL SYNTHESIS MODEL 1725. AFTER SEVERAL DAYS THE LEVEL DID NOT DROP SIGNIFICANTLY AND THE PATIENT WAS GIVEN INCREASING LEVELS OF OXYGEN THROUGH A LOW FLOW MASK DEVICE. RECORDS SHOW THE PATIENT WAS GIVEN 100% OXYGEN FOR APPROXIMATELY 12 HRS BEFORE THE TECHNICIAN NOTED THAT THE SYNTHESIS WAS MALFUNCTIONING DUE TO A CLOT IN THE OPTICAL WINDOW. AFTER REMOVAL OF THE CLOT, THE PATIENT WAS RE-TESTED ON THE SYNTHESIS AND THE COHB READING WAS ZERO. ACCORDING TO THE HOSPITAL, THE PATIENT WAS RELEASED WITH NO ADVERSE AFFECTS FROM THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNTHESIS BLOOD GAS/ELECTROLYTE/GLUCOSE/CO-OXIMETER JKS INSTRUMENTATION LABORATORY CO. 1725 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Hospitalization