BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2061766 · Received April 18, 2011

    Report

    Report Number
    1061932-2011-00278
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Date of Event
    March 19, 2011
    Report Date
    March 19, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BCI FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR THIS EVENT. FSE FOUND POWER SUPPLY CABLE DAMAGED FROM LIQUID LEAK & ELECTRICAL SHORT; CABLE WAS UNUSABLE. FSE REPLACED THE MALE CONNECTOR TO THE REAR OF POWER SUPPLY, FUSES AND POWER CABLE. INSTRUMENT IS NOW OPERATIONAL. CUSTOMER STATED THAT THE LH PAK HAD BEEN PLACED ON TOP OF THE POWER SUPPLY AND WHEN REPLACING REAGENT, SOME FLUID MAY HAVE BEEN SPILLED. ROOT CAUSE FOR THE BURNING SMELL WAS ASSOCIATED WITH FLUID THAT LEAKED ONTO ELECTRICAL COMPONENTS.

    Description of Event or Problem · 1

    CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT A BURNING SMELL COMING FROM COULTER LH 750 HEMATOLOGY ANALYZER POWER SUPPLY. CUSTOMER REPORTED SEEING SMOKE, BUT NO SPARKS, ARCS OR FLAMES. THERE WAS NO NEED TO CALL THE FIRE DEPARTMENT, NOR USE A FIRE EXTINGUISHER. OPERATOR WAS WEARING A LAB COAT. THERE WERE NO PHYSICAL INJURIES TO ANYONE. THERE WAS NO CONTACT TO MUCOUS MEMBRANE OR BROKEN SKIN AND NO ONE SOUGHT MEDICAL ATTENTION. THERE WERE NO REPORTS OF DEATH OR SERIOUS INJURY CONNECTED WITH THIS EVENT.

    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 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1