BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2101390 · Received May 24, 2011

    Report

    Report Number
    1061932-2011-00470
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Date of Event
    April 24, 2011
    Report Date
    April 24, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BCI FIELD SERVICE ENGINEER (FSE) ORDERED A NEW FAN FOR THE INSTRUMENT AND CUSTOMER REPLACED THE FAN WHEN IT ARRIVED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BCI) TO REPORT THAT THE COULTER LH 750 HEMATOLOGY ANALYZER GENERATED THE MESSAGE "ANALYZER FAN FAILED". THE CUSTOMER SMELLED SMOKE, BUT DID NOT SEE ANY SMOKE, ARCS, SPARKS, NOR FLAMES. THE HOSPITAL MAINTENANCE DEPARTMENT USED A DEVICE TO DETECT HEAT, AND COULD NOT FIND ANY PROBLEMS. THE FIRE DEPARTMENT WAS NOT CONTACTED AND THERE WERE NO INJURIES OR EXPOSURE OF ANY KIND RELATED TO THE SMOKE SMELL. THE CUSTOMER POWERED THE INSTRUMENT AND COMPRESSOR OFF AND PLACED IT OUT OF SERVICE UNTIL BCI FIELD SERVICE ENGINEER (FSE) ARRIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® LH 750 HEMATOLOGY ANALYZER HEMATOLOGY ANALYZER GKZ BECKMAN COULTER INC. LH 750 NA

    Patients

    Seq Age Sex Outcome Treatment
    1