BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWER PROCESSOR

    MDR report key: 1990584 · Received February 15, 2011

    Report

    Report Number
    2050012-2011-00455
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    January 16, 2011
    Report Date
    January 17, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JQP
    PMA / PMN Number
    CL1 EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BCI FIELD SERVICE ENGINEER (FSE) VISITED THE SITE ON (B)(6) 2011. THE FSE DID NOT FIND ANY BURNT OR SMOKE MARKS IN THE AREA OF THE REPORTED FLAMES. HOWEVER, A STRONG ODOR OF BURNT ELECTRONICS WAS NOTICEABLE AT THE COMPRESSOR. THE FSE INFORMED THE CUSTOMER THE INSTRUMENT WOULD BE INOPERABLE UNTIL FURTHER NOTICE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO SMALL FLAMES OBSERVED FROM POWER PROCESSOR. THE FLAMES WERE ON THE 3000 TUBE STOCKYARD PORTION OF POWER PROCESSOR AND WERE SELF-EXTINGUISHED. THE FIRE DEPARTMENT WAS DISPATCHED. THE CUSTOMER REMOVED POWER FROM THE STOCKYARD. THERE WAS NO REPORT OF INJURY OR PROPERTY LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWER PROCESSOR DATA PROCESSING SYSTEM JQP BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1