BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2210886 · Received August 12, 2011

    Report

    Report Number
    2050012-2011-04487
    Event Type
    Malfunction
    Date Received
    August 12, 2011
    Date of Event
    July 16, 2011
    Report Date
    July 16, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BEC CTS (CUSTOMER TECHNICAL SUPPORT) ASSISTED THE CUSTOMER WITH SHUTDOWN AND REBOOT. CTS GENERATED A SERVICE REQUEST AND A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON-SITE (B)(4) 2011. FSE FOUND THAT THE HIGH PRESSURE REGULATOR WOULD NOT ADJUST PAST 16.8PSI. FSE REPLACED THE PRESSURE REGULATOR ON (B)(4) 2011 WHICH RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) STATING THEY HAD A WASH CONCENTRATE SPILL IN THE HYDROPNEUMATIC AREA OF THE UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEM. NO INJURY OR EXPOSURE WAS REPORTED AND NO ERRONEOUS RESULTS WERE GENERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 800 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1