BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYSMEX XS-1000I ANALYZER

    MDR report key: 3397157 · Received September 20, 2013

    Report

    Report Number
    3009711478-2013-00011
    Event Type
    Other
    Date Received
    September 20, 2013
    Date of Event
    August 22, 2013
    Report Date
    August 23, 2013
    Manufacturer
    SYSMEX CORP.
    Product Code
    GKZ
    PMA / PMN Number
    K060656
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE UPS IS MANUFACTURED BY "POWERVAR INC." AND IT IS SUPPLIED BY (B)(4) AS AN ACCESSORY TO THE HEMATOLOGY ANALYZER. POWERVAR INC, (B)(4). THE (B)(4) FIELD SERVICE REPRESENTATIVE (FSR) WAS DISPATCHED TO THE USER'S LOCATION. FSR FOUND THE UPS AND LINE CONDITIONER LOCATED BELOW THE ANALYZER ON THE FLOOR. NO MALFUNCTION OF THE AUTOMATED HEMATOLOGY ANALYZER XS-1000I WAS REPORTED. THE UPS WAS PLACED BY THE CUSTOMER IN AN AREA WHERE THE WASTE LINE DRAINS FROM THE ANALYZER, PRESENTING THE POSSIBILITY OF FLUID CONTACTING THE UPS. A (B)(4) TECHNICAL SUPPORT MANAGER REVIEWED IMAGES AND DOCUMENTATION PERTAINING TO THE EVENT AND THEORIZED THAT THE FIRE STARTED OUTSIDE OF THE UPS, AND WAS LIKELY CAUSED BY LEAKAGE FROM THE ANALYZER'S WASTE LINE. THE FSR REPORTED THERE WAS NO INDICATION THAT THE FIRE WAS GENERATED FROM THE BATTERIES ENCASED INSIDE OF THE UPS. FSR REPLACED THE UPS AND VERIFIED THE ANALYZER'S OPERATIONS. THE UPS WAS RETURNED TO POWERVAR INC FOR EVALUATION FOR ROOT CAUSE DETERMINATION.

    Description of Event or Problem · 1

    THE USER OF A XS-1000I AUTOMATED HEMATOLOGY ANALYZER (SERIAL NUMBER (B)(4)) CONTACTED THE TECHNICAL ASSISTANCE CENTER (TAC) ON (B)(6) 2013 TO REPORT AN OCCURRENCE OF FIRE FROM THEIR UNINTERRUPTIBLE POWER SUPPLY (UPS); THE FIRE WAS EXTINGUISHED USING A FIRE EXTINGUISHER. THE USER REPORTED POWERING UP THE ANALYZER FOR THE DAY AS USUAL AND WHILE RUNNING QUALITY CONTROL (QC) THE INFORMATION PROCESSING UNIT (IPU) DISPLAYED A RED ICON FOR THE MAIN UNIT (MU); THE MU WOULD NOT CONTINUE, THEREFORE, THE USER REBOOTED THE ANALYZER AND FINISHED RUNNING QUALITY CONTROL. AFTER THE COMPLETION OF ANALYZER START-UP, THE USER NOTED FIRE COMING FROM THE UPS DESPITE THE FACT THE ANALYZER WAS IDLE. THE FIRE APPEARED TO HAVE ORIGINATED NEAR THE POWER-IN CONNECTOR ON THE UPS. THE CONNECTOR, FEMALE END OF THE POWER CORD AND THE WIRES COMING FROM THE CONNECTOR MELTED. THE USER REPORTED NO VISIBLE DAMAGE TO THE ANALYZER OR THE ANALYZER'S POWER CORD. THE USER REPORTED THAT NO ONE INCURRED SHOCK OR BURNS, OR WERE INJURED OTHERWISE DURING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476677 SYSMEX XS-1000I ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ SYSMEX CORP. XS-1000I

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening