BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 2882694 · Received December 20, 2012

    Report

    Report Number
    3007231105-2012-00011
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    November 21, 2012
    Report Date
    December 19, 2012
    Manufacturer
    AQUATEC OPERATIONS GMBH
    Product Code
    IKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    AFTER COMMUNICATING WITH THE FATHER OF THE END USER, THE DEALER HAS CALLED IN TO REPORT THE FRAME IS BROKEN. IT WAS LEARNED THAT THE END USER WAS BY HIS BED AT THE TIME OF THE INCIDENT. NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DAILY ACTIVITY ASSIST DEVICES 890.5050 IKX AQUATEC OPERATIONS GMBH A712900

    Patients

    Seq Age Sex Outcome Treatment
    1 31 Other