BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2052362 · Received April 12, 2011

    Report

    Report Number
    2050012-2011-01085
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 14, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BCI FIELD SERVICE ENGINEER (FSE) VISITED THE SITE ON (B)(6) 2011. THE FSE REPLACED THE VACUUM AND COMPRESSOR/VACUUM PUMPS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) AND REPORTED A NO FOAM LEAK IN THE HYDRO AREA OF UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEM. THE CUSTOMER STATED THAT MOST OF NO FOAM WENT INTO THE CANISTER AND THEN FLOODED INTO THE COMPARTMENT. NO INJURY WAS REPORTED AND THERE WAS NO EFFECT TO PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM CLINICAL CHEMSTRY ANALYZER JJE BECKMAN COULTER, INC. DXC 600 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1