BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 SYNCHRON® SYSTEM

    MDR report key: 2233756 · Received September 3, 2011

    Report

    Report Number
    2050012-2011-05026
    Event Type
    Malfunction
    Date Received
    September 3, 2011
    Date of Event
    August 5, 2011
    Report Date
    August 5, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED TO THE SITE TO ADDRESS THIS ISSUE. THE FIELD SERVICE ENGINEER (FSE) DISCOVERED A BUILDUP OF DUST HAD CLOGGED THE FANS ON THE POWER SUPPLY, THUS RESULTING IN OVERHEATING. THE FSE BELIEVED THAT THE THERMOFUSE FAILED AS A RESULT OF THE OVERHEATING. THE FSE INDICATED THE OUTSIDE OF THE POWER SUPPLIES SHOWED NO SIGN OF FIRE. THE FSE ALSO OBSERVED THAT THE UPS 220 FUSE WAS BLOWN, SO THE PART WAS REPLACED. THE FSE REPLACED THE 24VOLT AND 36VOLT POWER SUPPLIES AND CLEANED OUT THE POWER CAGE. THE INSTRUMENT WAS PERFORMANCE TESTED AND THE FSE INDICATED THAT THE INSTRUMENT POWERED UP APPROPRIATELY. THE INSTRUMENT WAS RETURNED TO SERVICE AFTER COMPLETION OF THE NECESSARY REPAIRS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2011 A BURNING ODOR WAS NOTED COMING FROM THE UNICEL DXC 800 SYNCHRON SYSTEM AFTER THE CUSTOMER ATTEMPTED TO TROUBLESHOOT A POWER ISSUE ON THE INSTRUMENT. THE CUSTOMER HAD JUST UNPLUGGED THE INSTRUMENT AND REPLUGGED IT INTO ANOTHER UNINTERRUPTIBLE POWER SUPPLY WHEN THE ODOR WAS OBSERVED. UPON PRESENCE OF THE BURNING ODOR THE CUSTOMER UNPLUGGED THE INSTRUMENT. PRIOR TO THE INSTRUMENT SHUT DOWN, THE UNIT WOULD NOT REBOOT AND HAD ISSUED SMART MODULE VOLTAGE ERRORS FOR MULTIPLE SMART MODULES. THERE WAS NO VISIBLE SMOKE, SPARKS, FLAME OR ARCING OBSERVED FROM THE DEVICE. THE LABORATORY WAS NOT EVACUATED AND THE FIRE DEPARTMENT WAS NOT CALLED. THE CUSTOMER WAS NOT INJURED AND DID NOT SEEK MEDICAL INTERVENTION IN ASSOCIATION WITH THIS EVENT. THERE WAS NOT DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ATTRIBUTED TO THIS EVENT. NO PATIENT RESULTS WERE ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 SYNCHRON® SYSTEM ANALYZER, CHEMISTRY JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1