BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IL GEM 4000 ABG ANALYZER

    MDR report key: 2993978 · Received December 21, 2012

    Report

    Report Number
    MW5029220
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Report Date
    December 21, 2012
    Manufacturer
    INSTRUMENTATION LABORATORIES
    Product Code
    CHL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IL GEM 4000 PO2 MALFUNCTION APPEARS ON THE CORRECTIVE ACTION REPORT IMMEDIATELY FOLLOWING THE RUNNING OF A QUESTIONABLE PT SAMPLE. IQM HAS 2 MODES ON/OFF. THE DEFAULT SET UP IS OFF. THIS IS HOW THE MFR SET UP OUR INSTRUMENT. IF IQM IS TURNED ON, THE TEST TAKES 3 MINS. IF THERE IS A PO2 SENSOR ERROR, A FLAG WILL BE DISPLAYED WITH THE RESULT AND A WARNING MESSAGE POPS UP STATING THAT THE LAST PO2 RESULT IS QUESTIONABLE. IF IQM IS TURNED OFF, THE TEST TAKES 90 SECS. THE RESULT IS DISPLAYED WITHOUT A WARNING, BUT A DIALOG BOX WILL POP UP AFTER IQM IS RUN TO WARN THE OPERATOR THAT THE RESULT IS QUESTIONABLE AND IN OUR SYSTEM WHICH IS SET UP FOR AUTO-VERIFICATION. THE ONLY CHOICE PROVIDED TO THE OPERATOR IS TO ACCEPT THE QUESTIONABLE RESULT. THE QUESTIONABLE RESULT THEN POPULATES THE PT'S RECORD WITH NO WARNING THAT THE RESULT IS QUESTIONABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IL GEM 4000 ABG ANALYZER GEM 4000 CHL INSTRUMENTATION LABORATORIES

    Patients

    Seq Age Sex Outcome Treatment
    1