BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2993491 · Received March 7, 2013

    Report

    Report Number
    1525712-2013-01755
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Report Date
    February 6, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    THE DEALER REPORTED THAT THE CHAIR WAS PULLING TO THE LEFT AND LATER DISPLAYED AN ERROR CODE 7 WHICH IS FOR A JOYSTICK COMMUNICATION FAULT. THIS COULD POTENTIALLY INJUR THE USER BECAUSE OF ERRATIC MOVEMENT OR LEAVE THE USER STRANDED BECAUSE OF A JOYSTICK ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98044 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET M91

    Patients

    Seq Age Sex Outcome Treatment
    1 Other