BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMERSION HYDROBATH

    MDR report key: 2955970 · Received February 11, 2013

    Report

    Report Number
    1525712-2013-01011
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Report Date
    February 11, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ILJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MDR HAS BEEN INITIATED FOR THIS ISSUE. THE MALFUNCTION HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 1

    PER (B)(6) WITH EBENEZER RIDGES 952 898 8400 THE DOOR SEAL PART NUMBER (B)(4) WAS NEEDED FOR A TUB MODEL IH3600XL SERIAL NUMBER (B)(4)...DOOR IS LEAKING AND THE SEAL HAS A LIFETIME WARRANTY/ NO FOLLOW UP REQUIRED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58011 IMMERSION HYDROBATH 890.5100 ILJ INVACARE TAYLOR STREET IH3600XL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other