BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® CX5 DELTA CHEMISTRY ANALYZER

    MDR report key: 2221137 · Received August 23, 2011

    Report

    Report Number
    2050012-2011-04726
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Date of Event
    March 15, 2011
    Report Date
    March 15, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K881495
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER TURNED OFF THE INSTRUMENT. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND DID NOT REPAIR THE INSTRUMENT, AS THE INSTRUMENT WAS DECOMMISSIONED. THE FSE ATTEMPTED TO RECOVER QC DATA AFTER FATAL ERROR IN THE CUSTOMER'S DATABASES, BUT WAS UNABLE TO RECOVER QC FILES. INSTRUMENT WAS RETURNED TO BEC AS INOPERABLE. BEC IDENTIFIER FOR THIS REPORT IS (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) STATING THAT A "BURNING ODOR" WAS DETECTED FROM THE SYNCHRON CX5 DELTA CHEMISTRY ANALYZER AND A "RED STATUS" WAS OBSERVED AT THE POWER SUPPLY (PS) #3. THE CUSTOMER WAS NOT HARMED AND NO TREATMENT WAS NECESSARY DUE TO ODOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® CX5 DELTA CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. CX5 DELTA N/A

    Patients

    Seq Age Sex Outcome Treatment
    1