BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMO

    MDR report key: 2894361 · Received December 27, 2012

    Report

    Report Number
    9611530-2012-00227
    Event Type
    Malfunction
    Date Received
    December 27, 2012
    Date of Event
    November 27, 2012
    Report Date
    November 27, 2012
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    ILJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER THE EXEMPTION (B)(4) BY THE MANUFACTURER ARJO (B)(4) ON BEHALF OF THE IMPORTER (B)(4). FURTHER INFO WILL FOLLOW UPON COMPLETION OF THE MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LEGIONELLA WAS FOUND IN THE BATH SYSTEM. INFECTED AND WORN PARTS HAVE BEEN REPLACED AND PIPES HAVE BEEN FLUSHED TO SOLVE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIMO BATH SYSTEMS ILJ ARJO HOSPITAL EQUIPMENT AB

    Patients

    Seq Age Sex Outcome Treatment
    1