BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 RACK

    MDR report key: 1200094 · Received October 15, 2008

    Report

    Report Number
    1823260-2008-07615
    Event Type
    Malfunction
    Date Received
    October 15, 2008
    Date of Event
    October 7, 2008
    Report Date
    October 15, 2008
    Manufacturer
    HITACHI HIGH TECH CORP
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER EXPERIENCED CONTINUED LEAK FROM THE ANALYZER THAT STARTED IN 2008. THE LEAK WAS REACHING ONTO THE FLOOR AND INTO THE WALKWAY. THE USER WAS NOT HARMED AND NO PATIENT SAMPLES WERE AFFECTED. THE FIELD SERVICE REPRESENTATIVE FOUND THAT A RUBBER GASKET WAS NOT SEALING CORRECTLY ON THE WATER RESERVOIR. THE GASKET WAS CLEANED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECSYS 2010 RACK IMMUNOCHEMISTRY ANALYZER - JJE JJE HITACHI HIGH TECH CORP 2010 RACK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK