BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3941919 · Received July 17, 2014

    Report

    Report Number
    1525712-2014-03771
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 12, 2014
    Manufacturer
    INVACARE
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CONSUMERS MOTHER STATED THAT THE CHAIR MOVES ON ITSELF INTERMITTENTLY CAUSING HER TO RUN INTO THE WALL AND PRACTICALLY RUNNING OVER HER BROTHER. RECALL HAS NOT BE ISSUED YES REFER TO WHEELCHAIR AND SCOOTER REPAIRS FOR REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418581 POWERED WHEELCHAIR 890.3860 ITI INVACARE TDXSP

    Patients

    Seq Age Sex Outcome Treatment
    1 15 Other