BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BECKMAN GS-6R

    MDR report key: 181726 · Received August 3, 1998

    Report

    Report Number
    2912312-1998-00001
    Event Type
    Malfunction
    Date Received
    August 3, 1998
    Date of Event
    July 1, 1998
    Report Date
    July 27, 1998
    Manufacturer
    BECKMAN INSTRUMENTS, INC.
    Product Code
    JQC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER STATES THAT THEY HAD MODIFIED A PLATE CARRIER FROM A TH-4 ROTOR SO THEY COULD SPIN THE PLATES IN THE GS-6R CENTRIFUGE USING A 3.7 YOKE. THE INCORRECT AND MODIFIED CARRIER WAS THEN ACCIDENTALLY SPUN AT A SPEED OF 5500 RPM, WHEN THEIR INTERNAL PROCEDURE CALLED FOR A SPEED OF 1000 RPM. THE CARRIER FAILED UNDER THIS STRESS AND INTERIOR ROTOR COMPONENTS IMPACTED THE FRONT OF THE CHAMBER CAUSING THE PRIMARY AND SECONDARY LID LATCHES TO FAIL. ROTOR PARTS WERE THEN THROWN OUT OF THE CENTRIFUGE INTO THE WORK AREA. CUSTOMER DID NOT NOTIFY MFR OF THIS ISSUE. THIS EVENT WAS IDENTIFIED BY FIELD SERVICE PERSONNEL VISITING THE USER FACILITY ON A ROUTINE SERVICE CALL ON A DIFFERENT INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BECKMAN GS-6R CENTRIFUGE JQC BECKMAN INSTRUMENTS, INC. GS-6R NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other