BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMERSION HYDROBATH

    MDR report key: 3100739 · Received May 8, 2013

    Report

    Report Number
    1219590-2013-00029
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Report Date
    April 12, 2013
    Manufacturer
    INVACARE CLEVELAND STREET
    Product Code
    ILJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PER END FACILITY JETS ARE CRACKED AND LEAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200935 IMMERSION HYDROBATH 890.5100 ILJ INVACARE CLEVELAND STREET IH3602GXL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other