BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 2000

    MDR report key: 3110529 · Received April 11, 2013

    Report

    Report Number
    9611530-2013-00034
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    ILJ
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT IS BEING SUBMITTED UNDER EXEMPTION (B)(4) BY THE MANUFACTURER ARJO HOSPITAL EQUIPMENT (B)(4) ON BEHALF OF THE IMPORTER (B)(4). THE EVALUATION OF THE DEVICE TO DATE HAS BEEN CARRIED OUT BY A REPRESENTATIVE OF THE MANUFACTURER'S SALES AND SERVICE UNIT SUBSIDIARY DIVISION, NOT A DIRECT EMPLOYEE OF THE MANUFACTURER. ADDITIONAL INFORMATION WILL BE PROVIDED UPON COMPLETION OF THE MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157081 SYSTEM 2000 BATH SYSTEMS ILJ ARJO HOSPITAL EQUIPMENT AB

    Patients

    Seq Age Sex Outcome Treatment
    1