BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 4243504 · Received November 11, 2014

    Report

    Report Number
    3008262382-2014-01953
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    February 27, 2014
    Report Date
    October 24, 2014
    Manufacturer
    INVACARE REHABILITATION EQUIP
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE END USER STATES THE CHAIR, WHEN RECEIVED INITIALLY, HAS NEVER BEEN PROGRAMMED AND HAS VEERED TO ONE SIDE WITH DAMAGED SHROUDS AND BALD TIRES. HE STATES THE CHAIR HAS PUT HOLES IN HIS WALLS AND DAMAGED 2 CARS IN HIS PARKING LOT DUE TO THE VEERING INTERMITTENTLY. HE STATES HE LIVES IN A RETIREMENT HOME AND THE CHAIR DOES THE INTERMITTENT VEERING IN THE HALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727293 POWERED WHEELCHAIR 890.3860 ITI INVACARE REHABILITATION EQUIP M51PSEMIRED

    Patients

    Seq Age Sex Outcome Treatment
    1 Other