BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 2000

    MDR report key: 3111201 · Received April 19, 2013

    Report

    Report Number
    1419652-2013-00104
    Event Type
    Malfunction
    Date Received
    April 19, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 26, 2013
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    ILJ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ISSUE OCCURRED IN A SYSTEM 2000, A BATH SYSTEM FOR ASSISTED BATHING. IT WAS REPORTED FROM THE CUSTOMER THAT THERE WAS A LEAKAGE OF DISINFECTANT DURING FIRST USE OF THE HYDRO MASSAGE. AN ARJOHUNTLEIGH TECHNICIAN HAS EXAMINED THE DEVICE AN DIT WAS FOUND THAT THE NON RETURN VALVE ((B)(4)) WAS HANGING AND ADJUSTED/LOOSENED. IT WAS ALSO FOUND THAT IF THE VALVE WAS NOT OPEN, THE HYDRO PUMP PULL ARJO CLEAN IN TO THE TANK. MEASURED: 30 ML ARJO CLEAN PER 285 ML OF WATER. MFR #: 9611530-2013-00038.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170194 SYSTEM 2000 BATH SYSTEMS ILJ ARJO HOSPITAL EQUIPMENT AB AR

    Patients

    Seq Age Sex Outcome Treatment
    1