BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYAN ADP HIGH SPEED ANALYZER

    MDR report key: 1821919 · Received August 31, 2010

    Report

    Report Number
    1061932-2010-00131
    Event Type
    Malfunction
    Date Received
    August 31, 2010
    Date of Event
    August 2, 2010
    Report Date
    August 31, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    RUO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) CHECKED THE OUTLET POWER AND IT MEASURED 117VAC. PER PRODUCT LABELING, THE POWER REQUIREMENTS ARE 100V - 230V, 600VA (W), 50/60 HZ. A NEW WORKSTATION WAS ORDERED.

    Description of Event or Problem · 1

    DURING INSTALLATION OF THE UNIT, THE FIELD SERVICE ENGINEER (FSE) REPORTED SMOKE COMING FROM THE POWER SUPPLY WHEN IT WAS PLUGGED INTO THE WALL OUTLET. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYAN ADP HIGH SPEED ANALYZER FLOW CYTOMETER GKZ BECKMAN COULTER INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1