BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON CX7 CLINICAL SYSTEM

    MDR report key: 2083190 · Received May 10, 2011

    Report

    Report Number
    2050012-2011-01536
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    April 11, 2011
    Report Date
    April 11, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K904219
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER HAD ADJUSTED THE REAGENT PROBE TUBING AND CABLE SO THAT IT WAS NOT HITTING THE TOP COVER, THUS ELIMINATING SPLATTER. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED, BUT DID NOT PERFORM SERVICE. THE FSE STATED THAT REAGENT SPLATTER WAS NO LONGER AN ISSUE SINCE ADJUSTMENT WAS MADE. CUSTOMER WAS TO MONITOR THE INSTRUMENT AND IF THEY EXPERIENCE ANY FURTHER ISSUES, THE CUSTOMER WOULD HAVE THEIR BIOMED DEPARTMENT REPLACE THE SHEAR VALVE. AS OF (B)(6) 2011, NO FURTHER CALLS HAVE BEEN RECEIVED REGARDING THIS ISSUE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) REPORTING THAT THERE WAS RECURRING EVIDENCE OF DRIED LIQUID IN COMPARTMENT AROUND REAGENT PROBE ON SYNCHRON CX7 CLINICAL SYSTEM. NO INJURY WAS REPORTED ON THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON CX7 CLINICAL SYSTEM SYNCHRON CX7 CLINICAL SYSTEM JJE BECKMAN COULTER INC. CX7 NA

    Patients

    Seq Age Sex Outcome Treatment
    1