BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILENCER 2200

    MDR report key: 2072348 · Received April 27, 2011

    Report

    Report Number
    2072348
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    April 26, 2011
    Report Date
    April 27, 2011
    Manufacturer
    GLOBAL FOCUS MARKETING & DISTRIBUTION, LTD
    Product Code
    JQC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE SILENCER 2200 CENTRIFUGE SYSTEM MALFUNCTIONED AND ONE OF THE TEST TUBE BASKETS (3-4 LBS IN WEIGHT) FLEW OUT OF THE CHAMBER BUSTING THE 1/2 INCH FIBERGLASS COVER AND LATCH. THE EMPLOYEE WAS JUST INCHES AWAY FROM THE BASKET WHEN IT BECAME DISENGAGED FROM THE MACHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILENCER 2200 CENTRIFUGE SYSTEM JQC GLOBAL FOCUS MARKETING & DISTRIBUTION, LTD S2200 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *