BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 SYNCHRON® SYSTEM

    MDR report key: 2132933 · Received June 17, 2011

    Report

    Report Number
    2050012-2011-02396
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    February 6, 2011
    Report Date
    February 6, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED TO THE SITE ON (B)(4) 2011. THE FIELD SERVICE ENGINEER (FSE) REPLACED A BROKEN QUICK DISCONNECT SUMP FITTING, THE V22 VALVE AND THE V26 VALVE. THE FSE DID NOT SEE ANY DIRECT EVIDENCE OF AN ELECTRICAL MALFUNCTION ON THE ISOLATION VALVE OR IN THE GENERAL AREA OF THIS VALVE. ALTHOUGH THE INSTRUMENT WAS REPAIRED PRIOR TO RETURNING IT INTO SERVICE, A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2011, WHILE TROUBLE SHOOTING A SUMP PUMP ERROR ON THE UNICEL DXC 800 SYNCHRON SYSTEM, THEY OBSERVED A SPARK IN THE WASTE TO EXIT WASTE TRANSFER VALVE AREA. AFTER THIS OCCURRED, THE CUSTOMER POWERED DOWN THE UNIT AND CONTACTED BECKMAN COULTER INC FOR SERVICE. THERE WAS NO DEATH OR SERIOUS INJURY ASSOCIATED OR ATTRIBUTABLE TO 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