BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3000 TUBE REFRIGERATED STOCKYARD

    MDR report key: 3791581 · Received May 6, 2014

    Report

    Report Number
    2050012-2014-00217
    Event Type
    Malfunction
    Date Received
    May 6, 2014
    Date of Event
    April 5, 2014
    Report Date
    April 6, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K090588
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE AND EVALUATED THE INSTRUMENT. THE FSE DISCOVERED THAT THE CURRENT RELAY OF THE COMPRESSOR WAS BURNED AND PROCEEDED TO REPLACE THE CURRENT RELAY TO RESOLVE THE ISSUE. FAILURE MODE OF THE EVENT IS ATTRIBUTED TO A BURNT CURRENT RELAY. THE 3000 TUBE REFRIGERATED STOCKYARD INSTRUMENT MEETS THE UNDERWRITERS LABORATORY (UL) AND CANADIAN STANDARDS ASSOCIATION (CSA) STANDARDS. ADDITIONALLY, THE INSTRUMENT IS MADE OF MATERIALS THAT WOULD NOT SUPPORT OR SUSTAIN COMBUSTION AND ARE SELF-EXTINGUISHING. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LOUD NOISE AND BURNING SMELL COMING FROM THE REFRIGERATOR OF THE 3000 TUBE REFRIGERATED STOCKYARD INSTRUMENT. THE CUSTOMER DID NOT SEE ANY VISIBLE SMOKE OR FLAMES AND THE FIRE DEPARTMENT WAS NOT CALLED. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF A LABORATORY COAT, GLOVES AND EYE PROTECTION AT THE TIME OF THE EVENT AND THERE WAS NO REPORT OF INJURY. CUSTOMER TECHNICAL SUPPORT ASSISTED THE CUSTOMER WITH TROUBLESHOOTING OVER THE TELEPHONE AND ADVISED THE CUSTOMER TO DISCONNECT THE STOCKYARD REFRIGERATOR POWER CORD. THE CUSTOMER DISCONNECTED THE POWER CORD AND A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270386 3000 TUBE REFRIGERATED STOCKYARD ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1