BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 2071234 · Received April 27, 2011

    Report

    Report Number
    2050012-2011-01317
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    March 29, 2011
    Report Date
    March 29, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BCI FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR THIS EVENT. FSE REPLACED COMMUNICATION CABLES FOR BOTH MIXERS AND ISSUE WAS RESOLVED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT EXPOSED WIRE WITH CRACKED SHEATHING ON THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM'S REAGENT MIXER. NO EFFECT TO PATIENT OR USER IS CONNECTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 600I N/A

    Patients

    Seq Age Sex Outcome Treatment
    1