BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 1232551 · Received November 13, 2008

    Report

    Report Number
    1823260-2008-08371
    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
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER REPORTS A LARGE LEAK COMING FROM THE ANALYZER ONTO THE FLOOR. NO ONE WAS INJURED AND NO PATIENTS WERE INVOLVED. THE FIELD SERVICE REP DETERMINED THE CAUSE TO BE THE PINCH VALVE TUBING. THE USER REPLACED THE TUBING, AND THE FIELD SERVICE REP VERIFIED CORRECT PLACEMENT OF THIS TUBING. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPEC.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK