BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3971509 · Received July 31, 2014

    Report

    Report Number
    1525712-2014-04214
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Report Date
    June 26, 2014
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    THE PROVIDER STATES THE DRIVE LOCKOUT SWITCH IS INTERMITTENT. HE STATES THE END USER WAS RECLINED AND ATTEMPTED TO RETURN TO THE UPRIGHT POSITION AND THE UNIT STOPPED. NO INJURIES NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447661 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET TDXSP-CG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other