BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIKRO 120

    MDR report key: 1648138 · Received March 23, 2010

    Report

    Report Number
    MW5015330
    Event Type
    Malfunction
    Date Received
    March 23, 2010
    Date of Event
    December 16, 2009
    Report Date
    March 23, 2010
    Manufacturer
    A. HETTICH GMBH & CO. KG.
    Product Code
    GHK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GM
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE MOTOR SHAFT OF THE CENTRIFUGE BROKE BELOW THE ROTOR, ALLOWING THE ROTOR TO SPIN FREELY. IN SO DOING, THE ROTOR HIT THE INSIDE OF THE CENTRIFUGE LID CAUSING IT TO OPEN. THE FIXED ANGLE ROTOR CAME OUT OF THE CENTRIFUGE AND LANDED ON THE LAB BENCH WHERE IT STOPPED SPINNING. THERE WERE NO INJURIES. (B) (4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIKRO 120 MICRO CENTRIFUGE GHK A. HETTICH GMBH & CO. KG. 12040-01

    Patients

    Seq Age Sex Outcome Treatment
    1