BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON CX9 ALX CHEMISTRY ANALYZER

    MDR report key: 2345727 · Received November 4, 2011

    Report

    Report Number
    2050012-2011-07242
    Event Type
    Malfunction
    Date Received
    November 4, 2011
    Date of Event
    July 7, 2008
    Report Date
    July 7, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K950958
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE. THE FSE REPLACED TWO (2) POWER SUPPLIES. REPAIRS WERE VERIFIED PER ESTABLISHED PROCEDURES. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(6) 2008 AND (B)(6) 2010 OF COMPLAINTS FOR ADD'L REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC (BEC) TO REPORT SMELLING SMOKE AND HEARING A BANGING SOUND FROM THEIR SYNCHRON CX9 ALX CHEMISTRY ANALYZER. THERE WAS NO IMPACT TO PT SAMPLE RESULTS OR PT TREATMENT ASSOCIATED WITH THIS EVENT. THERE WAS NO INJURY TO THE CUSTOMER. MEDICAL ATTENTION WAS NOT SOUGHT. IT IS UNK IF THE FACILITY HAS A RISK MANAGEMENT PLAN IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON CX9 ALX CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK