BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    911 HITACHI

    MDR report key: 1193369 · Received October 7, 2008

    Report

    Report Number
    1823260-2008-07396
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    September 17, 2008
    Report Date
    October 7, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER EXPERIENCED A LEAK FROM UNDER THE ANALYZER AND ONTO THE FLOOR. NO PATIENT RESULTS WERE AFFECTED AND NO OPERATORS WERE HARMED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WAS BROKEN TUBING AT THE WATER SUPPLY TANK AND RECONNECTED IT. PERFORMANCE TESTS WERE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 911 HITACHI CLINICAL CHEMISTRY ANALYZER-JJE JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK