BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON CX5 DELTA CLINICAL SYSTEM (C13)

    MDR report key: 2140257 · Received June 27, 2011

    Report

    Report Number
    2050012-2011-02647
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    May 27, 2011
    Report Date
    May 27, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K881495
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BCI FIELD SERVICE ENGINEER (FSE) REPLACED THE SUMP PUMP BECAUSE THE SUMP WAS NOT DRAINING. FSE REPAIR VERIFIED PER ESTABLISHED PROCEDURES.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BCI) CUSTOMER TECHNICAL SUPPORT (CTS) IN REGARDS YELLOWISH FLUID LEAK FROM THE BOTTOM OF THE INSTRUMENT AND THE WASTE CANISTER WAS WET ON THE TOP. NO INJURY OR EXPOSURE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON CX5 DELTA CLINICAL SYSTEM (C13) CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. CX5 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1