BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 2000

    MDR report key: 3121714 · Received May 9, 2013

    Report

    Report Number
    1419652-2013-00114
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 23, 2013
    Report Date
    April 23, 2013
    Manufacturer
    ARJO HOSP EQUIPMENT AB
    Product Code
    ILJ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ISSUE OCCURRED WITH AN OLDER BATH SYSTEM, A SYSTEM 2000 FOR ASSISTED BATHING AND IT HAS BEEN REPORTED THAT LEGIONELLA HAS BEEN FOUND AFTER SAMPLES HAS BEEN TAKEN. AS AN CORRECTIVE ACTION THE SHOWER HANDLE, HOSES AND THE WATER INLET FILTER HAS BEEN CHANGED BY AN ARJOHUNTLEIGH TECHNICIAN. REF #9611530-2013-00044.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204895 SYSTEM 2000 BATH SYSTEMS ILJ ARJO HOSP EQUIPMENT AB AP31100-EU

    Patients

    Seq Age Sex Outcome Treatment
    1