BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 1232549 · Received November 13, 2008

    Report

    Report Number
    1823260-2008-08368
    Event Type
    Malfunction
    Date Received
    November 13, 2008
    Date of Event
    November 1, 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
    IA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER REPORTED LEAK COMING FROM THE FRONT OF THE INSTRUMENT AND ONTO THE FLOOR. THE LIQUID WAS AT LEAST TWO FEET IN FRONT OF THE INSTRUMENT AND IN A WALKWAY. NO ONE WAS INJURED AND NO PATIENTS WERE INVOLVED. THE FIELD SERVICE REP DETERMINED THE CAUSE TO BE A PLUGGED DRAIN LINE ON THE WASTE BOX. HE CLEANED THE DRAIN LINE. PERFORMANCE TESTS WERE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANALYTICAL P MODULE CLINICAL CHEMISTRY ANALYZER - JJE JJE HITACHI HIGH TECH. CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK