BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2880308 · Received December 19, 2012

    Report

    Report Number
    1525712-2012-03130
    Event Type
    Malfunction
    Date Received
    December 19, 2012
    Date of Event
    November 18, 2012
    Report Date
    December 18, 2012
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PROVIDER ALLEGES ARM TUBE FOR THE JOYSTICK BROKE. THE REPORTER HAS BEEN CONTACTED FOR ADDITIONAL INFORMATION. IT WAS LEARNED THE END USER IS HANDICAPPED AND IS UNABLE TO TELL WHAT EXACTLY HAPPENED TO BREAK THE JOYSTICK ARM TUBE. THE CHAIR HAS BEEN IN USE SINCE (B)(6) 2012. THE CHAIR HAS NOT YET BEEN FIXED BUT THE END USER HAS A BACK UP CHAIR. NO INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other