BEUDAMED
    FDA Adverse Event Other Summary report: N

    ORTHO SUMMIT PROCESSOR

    MDR report key: 592227 · Received April 14, 2005

    Report

    Report Number
    2250051-2005-50113
    Event Type
    Other
    Date Received
    April 14, 2005
    Date of Event
    March 15, 2005
    Report Date
    April 13, 2005
    Manufacturer
    HAMILTON BONADUZ AG
    Product Code
    JTL
    Report Source
    Distributor report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ORTHO SUMMIT PROCESSOR INSTRUMENT REPORTEDLY PRODUCED A A BURNING SMELL AFTER A POWER INTERUPTION AND COMMUNICATION ERROR FOR THE WASH/DISPENSE 2 MODULE. NO DEATH OR SERIOUS INJURY WAS ASSOICATED WITH THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHO SUMMIT PROCESSOR ELISA MICROWELL PLATE PROCESSOR JTL HAMILTON BONADUZ AG 7003015 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other