BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 3150959 · Received June 6, 2013

    Report

    Report Number
    3007231105-2013-00032
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Report Date
    May 10, 2013
    Manufacturer
    AQUATEC OPERATIONS GMBH
    Product Code
    IKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    POTENTIAL FOR INJURY ASSOCIATED WITH AN H605 BATH LIFT WHERE THE HANDSET OPERATES INTERMITTENTLY. THIS EVENT COULD RESULT IN INCONSISTENT OPERATION AND LEAVE THE USER STRANDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250499 DAILY ACTIVITY ASSIST DEVICES 890.5050 IKX AQUATEC OPERATIONS GMBH H605

    Patients

    Seq Age Sex Outcome Treatment
    1 Other