BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTANTA

    MDR report key: 2212800 · Received August 15, 2011

    Report

    Report Number
    2212800
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    May 26, 2011
    Report Date
    May 27, 2011
    Manufacturer
    HETTICH
    Product Code
    JQC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US

    Narratives

    Description of Event or Problem · 1

    SAMPLES HAD COMPLETED RUNNING IN THE CENTRIFUGE AND THE TECHNICIAN HIT THE LID RELEASE BUTTON. SHE PUT HER FINGERS UNDER THE LID TO LIFT IT AND THE LID PROCEEDED TO DRAW BACK DOWN ON HER FINGERS. THE DEVICE: HETTICH ROTANTA 460 CENTRIFUGE.======================MANUFACTURER RESPONSE FOR CENTRIFUGE, ROTANTA (PER SITE REPORTER)======================REPLACED GAS SHOCKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTANTA CENTRIFUGE JQC HETTICH 460 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *