BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2143399 · Received June 29, 2011

    Report

    Report Number
    2050012-2011-02522
    Event Type
    Malfunction
    Date Received
    June 29, 2011
    Date of Event
    May 30, 2011
    Report Date
    May 30, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) INSPECTED THE INSTRUMENT AND FOUND A SMALL LEAK FROM THE CONDENSATION BOWL. THE FSE ALSO FOUND NO FOAM BOTTLE HAD A SMALL AIR LEAK IN TOP FITTING. THE FSE REPLACED THE NO FOAM BOTTLE ASSEMBLY AND VERIFIED REPAIR PER ESTABLISHED PROCEDURES. HARDWARE IS THE ROOT CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) AND REPORTED THAT THEY OBSERVED LEAKING FROM THE HYDROPNEUMATIC UNIT IN UNICEL DXC 800 SYNCHRON CLINICAL SYSTEM. THE CUSTOMER STATED THAT IT APPEARED TO BE WASTE. A CUSTOMER TECHNICAL SUPPORT (CTS) GENERATED A SERVICE REQUEST. NO INJURY HAS BEEN REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1