BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEM 4000

    MDR report key: 8335163 · Received February 13, 2019

    Report

    Report Number
    8335163
    Event Type
    Malfunction
    Date Received
    February 13, 2019
    Date of Event
    November 9, 2018
    Report Date
    December 26, 2018
    Manufacturer
    INSTRUMENTATION LABORATORIES
    Product Code
    CHL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING THE MONTHLY REVIEW OF THE SEPTEMBER IQM DATA FOR THE GEM 4000 BLOOD GAS ANALYSIS INSTRUMENT, IT WAS DISCOVERED THAT THE REPORT WAS NOT GENERATED BY ONE OF THE INSTRUMENTS. DURING THE SUBSEQUENT MONTHLY REVIEW ANOTHER INSTRUMENT FAILED TO GENERATE THE REPORT. THE VENDOR WAS CONTACTED AND A SERVICE TICKET WAS OPENED. THE IS INSTRUMENTATION LABORATORIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129558 GEM 4000 BLOOD GAS ANALYZER CHL INSTRUMENTATION LABORATORIES

    Patients

    Seq Age Sex Outcome Treatment
    1