BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2072306 · Received April 28, 2011

    Report

    Report Number
    2050012-2011-01260
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    April 2, 2011
    Report Date
    April 2, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE (B)(6) 2011 AND REPLACED THE 36V POWER MODULE AND CLEANED THE POWER SUPPLY DRAWER.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT THEY WERE HAVING AN ISSUE WITH THEIR 36VOLT POWER SUPPLY FAILING. THE CUSTOMER REBOOTED THE SYSTEM AND 36VOLT POWER SUPPLY FAILURE REOCCURRED. THE CUSTOMER ALSO SMELLED A FAINT ELECTRONIC HEAT SMELL AND CTS ASSISTED WITH SECONDARY SHUTDOWN. NO INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1