BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH750 HEMATOLOGY ANALYZER

    MDR report key: 2121838 · Received May 20, 2011

    Report

    Report Number
    1061932-2011-00383
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    February 7, 2009
    Report Date
    February 7, 2009
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED FOR THE PERIOD BETWEEN JANUARY 1, 2008 AND OCTOBER 23, 2010 OF COMPLAINTS FOR ADDITIONAL EVENTS. ON (B)(4) 2009, A FIELD SERVICE ENGINEER VISITED THE SITE TO EVALUATE THE INSTRUMENT. HE MEASURED MULTIPLE ELECTRICAL COMPONENTS AND VERIFIED INSTRUMENT GROUNDING AND PERFORMANCE. THE ROOT CAUSE OF THIS INCIDENT WAS DETERMINED TO BE ELECTROSTATIC DISCHARGE INVOLVING ONE PERSON IN THE LABORATORY.

    Description of Event or Problem · 1

    ON (B)(6) 2009, THE CUSTOMER REPORTED THAT A LABORATORY TECHNICIAN HAD BEEN SHOCKED BY TOUCHING FRONT OF THE LH750 HEMATOLOGY ANALYZER. THE SAME INDIVIDUAL HAD RECEIVED A STATIC SHOCK FROM OTHER LABORATORY EQUIPMENT (A MICROSCOPE, NOT SUPPLIED BY BECKMAN COULTER) EARLIER THE SAME DAY. IT IS UNKNOWN IF THE TECHNICIAN WAS WEARING PROPER PERSONAL PROTECTIVE EQUIPMENT. THE HOSPITAL HAD AN ELECTRICIAN CHECK THE INSTRUMENT. THERE WAS NO EVIDENCE OF ELECTRICAL DISCHARGE. THERE WERE NO INJURIES. NO ONE SOUGHT MEDICAL ATTENTION AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER LH750 HEMATOLOGY ANALYZER GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK