BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEM 4000 PREMIER CARTRIDGE

    MDR report key: 8286551 · Received January 28, 2019

    Report

    Report Number
    MW5083452
    Event Type
    Malfunction
    Date Received
    January 28, 2019
    Date of Event
    January 17, 2019
    Report Date
    January 25, 2019
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Product Code
    CHL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    GEM 4000 ARTERIAL BLOOD GAS MACHINE EJECTED A CARTRIDGE BEFORE ITS EXPIRATION. THIS CARTRIDGE HAD A LEAK ON THE BOTTOM OF THE UNIT WHICH LEAKED ON THE BOTTOM OF THE ABG MACHINE. TWO NEW CARTRIDGE WERE THEN INSTALLED, BOTH OF WHICH FAILED DUE TO IQM ERROR. LEAKING CARTRIDGE LOT #18119C, SN. (B)(4). MANUFACTURER IS INSTRUMENTATION LABORATORY. DATES OF USE : (B)(6) 2018 - (B)(6) 2019, DIAGNOSIS OR REASON FOR USE: ARTERIAL BLOOD GAS MACHINE, IS THE PRODUCT COMPOUNDED? NO, IS THE PRODUCT OVER-THE-COUNTER? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74806 GEM 4000 PREMIER CARTRIDGE ELECTRODE MEASUREMENT, BLOOD GASES (PCO2, PO2) AND BLOOD PH CHL INSTRUMENTATION LABORATORY CO. GEM4000 PAK 181119C
    74807 GEM 4000 PREMIER CARTRIDGE ELECTRODE MEASUREMENT, BLOOD GASES (PCO2, PO2) AND BLOOD PH CHL INSTRUMENTATION LABORATORY CO. 181119C

    Patients

    Seq Age Sex Outcome Treatment
    1