BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWER PROCESSOR WITH LINE CONTOLLER

    MDR report key: 1905215 · Received November 22, 2010

    Report

    Report Number
    2050012-2010-01356
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 27, 2010
    Report Date
    October 27, 2010
    Manufacturer
    BECKMAN COULER INC.
    Product Code
    JQP
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A BCI FIELD SERVICE ENGINEER (FSE) DISCOVERED THE END TRACK DID NOT TURN ON WHEN LINE WAS ON. FSE NOTICED THE GREEN BELTS WERE OFF FROM INLET TO FIRST HANDING TRACK PAST THE SMART H LINE. FSE REPLACED A BURNED CONNECTOR. FSE POWERED UP THE LINE AND ALL TRACKS BELTS WERE IN WORKING ORDER.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO TRACKS NOT MOVING ON THE AUTOMATION LINE. NO OPERATOR EXPOSURE OF INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWER PROCESSOR WITH LINE CONTOLLER CLINICAL AUTOMATION JQP BECKMAN COULER INC. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1