BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVIOS FLOW CYTOMETER, 10 COLOR/3 LASER

    MDR report key: 7220569 · Received January 25, 2018

    Report

    Report Number
    1061932-2018-00002
    Event Type
    Malfunction
    Date Received
    January 25, 2018
    Date of Event
    January 7, 2018
    Report Date
    January 7, 2018
    Manufacturer
    BECKMAN COULTER IRELAND
    Product Code
    OYE
    UDI-DI
    15099590515522
    PMA / PMN Number
    K990352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND THE DATA INNOVATION PC WAS REPLACED WITH A NEW PC. INSTRUMENT WAS AGAIN OPERATIONAL. THE COMPUTER (DATA INNOVATION PC) WAS RETURNED FOR INVESTIGATION TO BEC AND WAS RECEIVED ON JANUARY 23, 2018. THE COMPUTER AND ITS PARTS WERE ASSESSED. THE DAMAGE WAS TOO EXTENSIVE WITHIN THE POWER SUPPLY TO DETERMINE THE SPECIFIC CAUSE OF THIS INTERNAL FIRE. HOWEVER, WHATEVER FIRE THAT DID OCCUR WAS COMPLETELY CONTAINED WITHIN THE POWER SUPPLY SECTION OF THE COMPUTER ITSELF, AND SELF-EXTINGUISHED ON ITS OWN ONCE POWER WAS REMOVED. THERE IS NO EVIDENCE OF ANY FLAMES ESCAPING THE CABINET. IT WAS OBSERVED THAT THERE WAS A LARGE QUANTITY OF DUST ACCUMULATED WITH THE PC AND THE POWER SUPPLY ITSELF. BEC INTERNAL IDENTIFIED - (B)(4).

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND THE DATA INNOVATION PC WAS REPLACED WITH A NEW PC. INSTRUMENT WAS AGAIN OPERATIONAL. THE COMPUTER (DATA INNOVATION PC) WAS RETURNED FOR INVESTIGATION TO BEC AND WAS RECEIVED ON JANUARY 23, 2018. THE COMPUTER AND ITS PARTS WERE ASSESSED. THE DAMAGE WAS TOO EXTENSIVE WITHIN THE POWER SUPPLY TO DETERMINE THE SPECIFIC CAUSE OF THIS INTERNAL FIRE. HOWEVER, WHATEVER FIRE THAT DID OCCUR WAS COMPLETELY CONTAINED WITHIN THE POWER SUPPLY SECTION OF THE COMPUTER ITSELF, AND SELF-EXTINGUISHED ON ITS OWN ONCE POWER WAS REMOVED. THERE IS NO EVIDENCE OF ANY FLAMES ESCAPING THE CABINET. IT WAS OBSERVED THAT THERE WAS A LARGE QUANTITY OF DUST ACCUMULATED WITHIN THE PC AND THE POWER SUPPLY ITSELF. IN AN ABUNDANCE OF CAUTION BEC HAS REPORTED THE EVENT. FOLLOW UP: - IMPORTANT SUPPLEMENTAL INFORMATION UPON FURTHER ASSESSMENT, BEC DETERMINED THAT THE PERSONAL COMPUTER (PC) INVOLVED IN THIS EVENT WAS NOT PART OF THE INSTALLED NAVIOS SYSTEM BUT WAS USED TO RUN THIRD PARTY SOFTWARE THAT FACILITATED BI-DIRECTIONAL COMMUNICATION WITH THE FACILITY'S LABORATORY INFORMATION SYSTEM (LIS). THE AFFECTED PERSONAL COMPUTER IS NOT A MEDICAL DEVICE OR AN ACCESSORY DEVICE TO THE NAVIOS SYSTEM; I.E., THE NAVIOS SYSTEM IS INDEPENDENT OF THE THIRD PARTY SOFTWARE AND IS CAPABLE OF PROCESSING PATIENT SAMPLES WITHOUT THE USE OF THE AFFECTED PC. THE NAVIOS SYSTEM WAS FULLY OPERATIONAL AND HAD NO REPORTED ISSUES RELATED TO THIS EVENT. ON APRIL 10, 2018, BEC FOLLOWED UP WITH THE CUSTOMER BY PHONE TO PROVIDE THE FOLLOWING RESULTS OF THE EVENT EVALUATION: THE CUSTOMER WAS INFORMED THAT THE INVESTIGATION WAS COMPLETED AND A REPLACEMENT PC HAD BEEN PROVIDED. IT WAS OBSERVED THAT THE RETURNED PC WAS DUSTY AND THAT MAY HAVE BEEN A CONTRIBUTING FACTOR TO THE OCCURRENCE. BEC WILL BE POSTING AN ADVISORY LETTER ON OUR WEBSITE RECOMMENDING THAT CUSTOMERS ADD INSPECTION AND CLEANING OF PCS TO ROUTINE LABORATORY MAINTENANCE. THE CUSTOMER WAS ASKED AND STATED THAT THEY HAD NO ADDITIONAL QUESTIONS AND APPRECIATED THE FEEDBACK. THE CUSTOMER ALSO STATED THAT THEIR INTERNAL LABORATORY PROCEDURE HAS BEEN REVISED TO SHUT DOWN THE PC AT THE END OF EACH WORK DAY. PREVIOUSLY THE PC WAS LEFT ON AROUND THE CLOCK. BEC INTERNAL IDENTIFIER - (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE POWER SUPPLY FOR THE DATA INNOVATION PC OF THEIR NAVIOS INSTRUMENT CAUGHT FIRE. THERE WAS A CONTAINED FIRE AND SMOKE REPORTED. THERE WAS NO DEATH OR INJURY ASSOCIATED WITH THE EVENT. MEDICAL ATTENTION WAS NOT REQUIRED BY ANYONE INVOLVED IN THE EVENT. THE FIRE DEPARTMENT WAS CALLED BUT UPON THEIR ARRIVAL THERE WAS NO LONGER A FIRE. A FIRE EXTINGUISHER WAS NOT USED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE POWER SUPPLY FOR THE DATA INNOVATION PC OF THEIR NAVIOS INSTRUMENT CAUGHT FIRE. THERE WAS A CONTAINED FIRE AND SMOKE REPORTED. THERE WAS NO DEATH OR INJURY ASSOCIATED WITH THE EVENT. MEDICAL ATTENTION WAS NOT REQUIRED BY ANYONE INVOLVED IN THE EVENT. THE FIRE DEPARTMENT WAS CALLED BUT UPON THEIR ARRIVAL THERE WAS NO LONGER A FIRE. A FIRE EXTINGUISHER WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62424 NAVIOS FLOW CYTOMETER, 10 COLOR/3 LASER FLOW CYTOMETER OYE BECKMAN COULTER IRELAND 10 COLOR 3 LASERS 15099590515522

    Patients

    Seq Age Sex Outcome Treatment
    1