BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM

    MDR report key: 7144005 · Received December 22, 2017

    Report

    Report Number
    1061932-2017-00022
    Event Type
    Malfunction
    Date Received
    December 22, 2017
    Date of Event
    November 30, 2017
    Report Date
    November 30, 2017
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    UDI-DI
    15099590381646
    PMA / PMN Number
    K140911
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2017 THE FIELD SERVICE ENGINEER (FSE) REPLACED THE SAMPLE ASPIRATION MODULE (SAM) MODULE RESOURCE CONTROLLER (MRC) TO RESOLVE THE BLOOD SAMPLING VALVE (BSV) MECHANICAL DRIVE COMMUNICATION ISSUE; PER PHONE COMMUNICATION WITH THE FSE ON (B)(4) 2017, THIS IS WHEN THE SPARK AND FLAME WAS OBSERVED COMING FROM THE SAM MRC BOARD. THE FSE REPLACED THE AFFECTED SAM MRC BOARD RESOLVING THE ISSUE. PER BECKMAN COULTER PRODUCT COMPLIANCE ENGINEER, THERE IS NO ELECTRICAL HAZARD PRESENT ON AN MRC BOARD. THE BOARDS OPERATES AT 24 VDC, WHICH IS CONSIDERED A NON-HAZARDOUS VOLTAGE PER SAFETY STANDARD IEC 61010-1 AND IS CONSIDERED SELF-EXTINGUISHABLE. WITH REGARDS TO THE SPARK AND SMALL FLAME SEEN ON THE INSTRUMENT, THIS EVENT IS NOT CLASSIFIED AS A FIRE EVENT, AT BEST THIS EVENT IS CONSIDERED A MOMENTARY EVENT CAUSED EITHER BY A LOW VOLTAGE COMPONENT FAILURE, OR BY THE INADVERTENT SHORTING OF THE BOARD DURING TROUBLESHOOTING. IN AN ABUNDANCE OF CAUTION, BEC HAS FILED THE REPORT FOR THIS EVENT BASED ON THE REPORTED VISIBLE FLAME. BEC INTERNAL IDENTIFIER - (B)(6).

    Description of Event or Problem · 1

    THE FIELD SERVICE ENGINEER (FSE) REPORTED OBSERVING A CLEAR SPARK THEN A SMALL FLAME WITH SMOKE AFTER THE INSTALLING THE SAMPLE ASPIRATION MODULE (SAM) MODULE RESOURCE CONTROLLER (MRC) BOARD WHILE TROUBLESHOOTING BLOOD SAMPLING VALVE (BSV) MOVE ERRORS ON THE DXH 800 INSTRUMENT. PER THE FSE THE MAGNITUDE OF THE FLAME WAS VERY SMALL AND CONTAINED WITHIN THE INSTRUMENT. A FIRE EXTINGUISHER WAS NOT NEEDED AND THE INSTRUMENT WAS IMMEDIATELY POWERED OFF. THE LAB WAS NOT EVACUATED. THERE WAS NO REPORTED INJURY AND NO MEDICAL ATTENTION WAS REQUIRED BY THE OPERATOR. ERRONEOUS RESULTS WERE NOT GENERATED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    921636 UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER N/A 15099590381646

    Patients

    Seq Age Sex Outcome Treatment
    1