BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR ANALYTICS CORE

    MDR report key: 1232556 · Received November 13, 2008

    Report

    Report Number
    1823260-2008-08375
    Event Type
    Malfunction
    Date Received
    November 13, 2008
    Date of Event
    November 2, 2008
    Report Date
    November 13, 2008
    Manufacturer
    HITACHI HIGH TECH. CORP
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER REPORTED A LEAK COMING FROM THE FRONT OF THE INSTRUMENT AND ONTO THE FLOOR INTO THE WALKWAY. NO ONE WAS INJURED AND NO PATIENTS WERE INVOLVED. THE FIELD SERVICE REP DETERMINED THE CAUSE TO BE A BACKED UP PROBE WASH DRAIN LINE. HE CLEARED THE OBSTRUCTION AND RINSED THE DRAIN WITH BLEACH AND HOT WATER. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPEC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODULAR ANALYTICS CORE CLINICAL CHEMISTRY ANALYZER - JJE JJE HITACHI HIGH TECH. CORP

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK