BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RHAPSODY

    MDR report key: 3030286 · Received March 28, 2013

    Report

    Report Number
    9611530-2013-00029
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 4, 2013
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT IS BEING SUBMITTED UNDER EXEMPTION (B)(4) BY THE MANUFACTURER ARJO (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

    THE ISSUE OCCURRED WITH AN OLDER BATH SYSTEM, A RHAPSODY FOR ASSISTED BATHING AND AS REPORTED FROM THE CUSTOMER THE FLUSH WAS BAD BECAUSE OF LEGIONELLA. AS AN CORRECTIVE ACTION THE SHOWER HANDLE, SEALS AND HOSES HAS BEEN CHANGED BY AN ARJOHUNTLEIGH TECHNICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129680 RHAPSODY BATH SYSTEMS FSA ARJO HOSPITAL EQUIPMENT AB ARB21010-01

    Patients

    Seq Age Sex Outcome Treatment
    1