BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 2000

    MDR report key: 3234044 · Received July 11, 2013

    Report

    Report Number
    1419652-2013-00191
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 10, 2013
    Manufacturer
    ARJO HOSPITAL EQUIMPENT, AB
    Product Code
    ILM
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ISSUE OCCURRED IN A SYSTEM 2000, A BATH SYS FOR ASSISTED BATHING, AND AS REPORTED THE BATH WAS INFECTED WITH THE LEGIONELLA. REF #9611530-2013-00082.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320766 SYSTEM 2000 ILM ARJO HOSPITAL EQUIMPENT, AB

    Patients

    Seq Age Sex Outcome Treatment
    1