BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENAISSANCE

    MDR report key: 563844 · Received May 21, 2004

    Report

    Report Number
    2028492-2004-00004
    Event Type
    Malfunction
    Date Received
    May 21, 2004
    Date of Event
    April 23, 2004
    Report Date
    May 21, 2004
    Manufacturer
    VENTANA MEDICAL SYSTEMS, INC.
    Product Code
    IEO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SITE REPORTED AN INSTRUMENT FAILURE WHICH MAY HAVE AFFECTED PT CARE. THE INSTRUMENT EXPERIENCED A ROTARY VALVE ERROR WHICH ABORTED THE RUN WITH PT TISSUE. THE INSTRUMENT WAS REPAIRED ON-SITE AND A DIAGNOSTIC PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENAISSANCE TISSUE PROCESSOR IEO VENTANA MEDICAL SYSTEMS, INC. TP 1530 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other