BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® LXI® 725 CLINICAL SYSTEM

    MDR report key: 1971114 · Received January 26, 2011

    Report

    Report Number
    2050012-2011-00228
    Event Type
    Malfunction
    Date Received
    January 26, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 1, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023049
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER TECHNICAL SUPPORT (CTS) ASSISTED THE CUSTOMER TO TROUBLESHOOT THE UNIT AND NOTED THE LEAK TO BE COMING FROM A REGULATOR. A BCI FIELD SERVICE ENGINEER (FSE) FOUND A HOLE IN V2 TUBE AND REPLACED THE TUBING. FSE PRIMED THE HYDRO PNEUMATIC. THE ISSUE HAS BEEN RESOLVED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO HYDROPNEUMATIC DRAWER LEAK. NO INJURY WAS REPORTED FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® LXI® 725 CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. LXI 725 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1