BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 4040212 · Received August 27, 2014

    Report

    Report Number
    3008262382-2014-00775
    Event Type
    Malfunction
    Date Received
    August 27, 2014
    Report Date
    May 15, 2014
    Manufacturer
    INVACARE REHABILITATION EQUIP
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    END USER'S DAUGHTER STATED THE CHAIR SLOWS DOWN AND SPEEDS UP WITHOUT HER FATHER GIVING THE COMMANDS, THE CHAIR AT TIMES HAS ONLY GONE IN REVERSE. CHAIR VEERED OFF SIDEWALK, AND TRACKED DIRT, AND MUD INTO THE HOUSE DAMAGING THE CARPETS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521284 POWERED WHEELCHAIR 890.3860 ITI INVACARE REHABILITATION EQUIP M41SRB

    Patients

    Seq Age Sex Outcome Treatment
    1 95 Other