BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 SYNCHRON® CLINICAL SYSTEM

    MDR report key: 1821962 · Received August 31, 2010

    Report

    Report Number
    2050012-2010-00676
    Event Type
    Malfunction
    Date Received
    August 31, 2010
    Date of Event
    July 16, 2010
    Report Date
    August 31, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE AND REPLACED THE CANISTERS.

    Description of Event or Problem · 1

    THE HYDROCANISTER LIDS OF THE WASTE EXIT SUMPS ON THE UNICEL DXC 800 SYNCHRON CLINICAL SYSTEM CRACKED. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 SYNCHRON® CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1