BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIOMETER

    MDR report key: 66965 · Received January 6, 1997

    Report

    Report Number
    66965
    Event Type
    Malfunction
    Date Received
    January 6, 1997
    Date of Event
    September 4, 1996
    Report Date
    October 10, 1996
    Manufacturer
    RADIOMETER AMERICA, INC.
    Product Code
    CHL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    BLOOD GAS SAMPLES WERE REJECTED BY THE MACHINE. MOST WERE REJECTED BECAUSE OF ERROR CODES ASSOCIATED WITH AIR BUBBLES IN THE SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIOMETER BLOOD GAS ANALYZER CHL RADIOMETER AMERICA, INC. ABL - 50 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DAY Other