BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 4132852 · Received October 1, 2014

    Report

    Report Number
    1525712-2014-06574
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Report Date
    September 15, 2014
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PROVIDER THAT HE SPOKE WITH INVACARE TECH SERVICES TO REPORT THAT THE CONSUMER STATED THE JOYSTICK WILL INTERMITTENTLY GO INTO A CONTROLLER FAULT AND THE SCREEN THEN TURNS BLACK. CONSUMER TOLD PROVIDER THEY HAVE TO GET THE CHAIR OUT OF GEAR AND BACK IN GEAR FOR IT TO WORK. PROVIDER CAN NOT CONFIRM THIS IS HAPPENING AS HE HAS NOT SEEN IT HAPPEN. NO PATIENT INJURY REPORTED, NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612456 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET TDXSP-CG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other