BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER EPICS XL-MCL 4 CLR FLOW CYTOMETRY SYSTEM

    MDR report key: 2326279 · Received October 21, 2011

    Report

    Report Number
    1061932-2011-01912
    Event Type
    Malfunction
    Date Received
    October 21, 2011
    Date of Event
    September 24, 2010
    Report Date
    September 24, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K990172
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE. THE FSE INVESTIGATED THE REPORTED ELECTRICAL SHOCK. THE FSE TOOK READINGS FROM GROUND TO ALL EXTERIOR METALS WITH NO READINGS HIGHER THAN 7MV. THE NON-CONDUCTIVE LOCK NUT WAS LOOSE. THE FSE REMOVED THE POWER UNIT COVER AND TIGHTENED THE LOCK NUT. THE FSE DID NOT OBSERVE ANY ADDITIONAL FINDINGS. THE FSE REPORTED THAT ALL THE ELECTRICAL WIRES THAT ARE CUSTOMER ACCESSIBLE WERE CHECKED AND NONE WERE FOUND TO BE CONDUCTIVE OR LIVE WHICH COULD CAUSE ELECTRIC SHOCK. WHILE A DEFINITIVE ROOT CAUSE WAS NOT DETERMINED FOR THIS EVENT, THE FSE REPORTED THAT THE SHOCK FELT BY THE CUSTOMER WAS MOST LIKELY A STATIC SHOCK. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(4) 2008 AND (B)(4) 2010 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED RECEIVING AN ELECTRIC SHOCK AFTER TOUCHING THE LASER UMBILICAL CORD OF A COULTER EPICS XL-MCL 4 CLR FLOW CYTOMETRY SYSTEM WHILE TROUBLESHOOTING AN INSTRUMENT PROBLEM WITH THE BECKMAN COULTER, INC. (BEC) CALL CENTER. THE CUSTOMER WAS WEARING A LAB COAT AT THE TIME OF THE EVENT. THE CUSTOMER WAS NOT WEARING GLOVES. THERE WAS NO REPORT OF DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS EVENT. MEDICAL ATTENTION WAS NOT SOUGHT. THE CUSTOMER REPORTED THAT HE WAS "OK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER EPICS XL-MCL 4 CLR FLOW CYTOMETRY SYSTEM GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK