BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMERSION HYDROBATH

    MDR report key: 2874306 · Received December 14, 2012

    Report

    Report Number
    1525712-2012-02986
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Report Date
    December 14, 2012
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ILJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    MDR DECISION DATE: (B)(4) KEL - NO RMA HAS BEEN INITIATED FOR THIS ISSUE. THE CONSUMER'S AGE, HEIGHT AND WEIGHT ARE UNKNOWN. THE CONSUMER'S MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN. THE CONSUMER'S TECHNIQUE WHILE USING THE DEVICE IS UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN. THE MALFUNCTION HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 1

    DEALER STATED THAT THE DOOR SEAL ON A IH3650 SIDE ENTRY TUB IS LEAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMERSION HYDROBATH 890.5100 ILJ INVACARE TAYLOR STREET IH3650

    Patients

    Seq Age Sex Outcome Treatment
    1 Other