BEUDAMED
    FDA Adverse Event Other Summary report: N

    ORTHO SUMMIT PROCESSOR

    MDR report key: 959617 · Received May 17, 2006

    Report

    Report Number
    2250051-2006-50229
    Event Type
    Other
    Date Received
    May 17, 2006
    Date of Event
    April 26, 2006
    Report Date
    May 16, 2006
    Manufacturer
    HAMILTON BONADUZ AG
    Product Code
    JJE
    Report Source
    Distributor report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ORTHO SUMMIT PROCESSOR (OSP) INSTRUMENT REPORTEDLY HAD SMOKE COMING FROM THE PUMP FOR WASH CHANNEL POSITION 1. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHO SUMMIT PROCESSOR ELISA MICROWELL PLATE PROCESSOR JJE HAMILTON BONADUZ AG 7003051 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other