BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 2942720 · Received February 4, 2013

    Report

    Report Number
    3007231105-2013-00005
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Report Date
    February 4, 2013
    Manufacturer
    AQUATEC OPERATIONS GMBH
    Product Code
    IKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE DEALER, THE USER WAS BEING BATHED WITH TWO STAFF MEMBERS ATTENDING. THE USER LEANED BACK ON THE UPHOLSTERY AND 3 OF THE 5 ADJUSTMENT BUCKLES UNCLIPPED FROM THE PRESSURE. NO INJURY ALLEGED.

    Description of Event or Problem · 1

    (B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. PER THE DEALER, THE FASTEX CLIPS ON BACKREST UPHOLSTERY ARE RELEASING WHEN PRESSURE APPLIED TO BACK UPHOLSTERY. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46358 DAILY ACTIVITY ASSIST DEVICES 890.5050 IKX AQUATEC OPERATIONS GMBH OCEAN VIP

    Patients

    Seq Age Sex Outcome Treatment
    1 Other