BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BECKMAN COULTER ¿ COULTER ® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2181978 · Received July 28, 2011

    Report

    Report Number
    1061932-2011-01040
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    June 25, 2011
    Report Date
    June 29, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BEC FIELD SERVICE ENGINEER (FSE) DID NOT FIND DAMAGE TO ANY OTHER EQUIPMENT AND WAS ADVISED THAT THE UPS WAS TAKEN BY THE BIOMED DEPARTMENT OF (B)(6) FOR FURTHER INVESTIGATION. THE BIO-MED DEPARTMENT DETERMINED THE ROOT CAUSE OF THE FIRE WAS DUE TO THE POWER CORD WAS NOT SEATED PROPERLY IN THE BACK OF THE POWER SUPPLY. IN ADDITION, THE CORD WAS CUTTING IN AND OUT OF POWER WHICH CAUSED IT TO OVERHEAT AND EVENTUALLY CATCH FIRE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BEC) TO REPORT OBSERVING FIRE COMING FROM THE UPS POWER SUPPLY ON THE LH750 ANALYZER. THE OPERATOR UNPLUGGED THE UNIT AND SUMMONED THE FIRE DEPARTMENT. THE FIRE DEPARTMENT FOUND THE FIRE WAS CONTAINED AS THE ANALYZER WAS UNPLUGGED IMMEDIATELY AFTER DISCOVERING THE FIRE. NO DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS EVENT AND NO ONE SOUGHT MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BECKMAN COULTER ¿ COULTER ® LH 750 HEMATOLOGY ANALYZER AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER INC. LH750 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1