BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® CX5 DELTA CLINICAL SYSTEM

    MDR report key: 2242223 · Received September 9, 2011

    Report

    Report Number
    2050012-2011-05039
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 9, 2011
    Report Date
    August 9, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K950958
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO SERVICE WAS PERFORMED BY A BEC FIELD SERVICE ENGINEER (FSE). THE CUSTOMER REPORTED TO CUSTOMER TECHNICAL SUPPORT (CTS) THAT THEY NO LONGER OBSERVED LEAKING FROM THE INSTRUMENT. CTS CANCELLED SERVICE REQUEST. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) STATING THAT THERE WAS A LEAK COMING FROM THE HYDROPNEUMATIC UNIT IN THE SYNCHRON CX5 DELTA CLINICAL SYSTEM. THE CUSTOMER WAS UNABLE TO IDENTIFY THE SOURCE OF THE LEAK BUT SAID IT APPEARED TO BE WASTE. NO INJURY OR OPERATOR EXPOSURE WAS REPORTED FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® CX5 DELTA CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. CX5 DELTA NA

    Patients

    Seq Age Sex Outcome Treatment
    1