BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2942713 · Received February 4, 2013

    Report

    Report Number
    1525712-2013-00800
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Report Date
    February 3, 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

    (B)(4) - THE DEALER REPORTED THAT THE TDXSP-CG POWER WHEELCHAIR RIGHT LEGREST WOULD RAISE ALL THE WAY UP, AND WOULD DROP DOWN ABOUT 1.5 INCHES. THE LEGRESTS WERE ORDERED SEPARATELY FROM CHAIR, AND WOULD BE REPLACED UNDER WARRANTY THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46044 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET TDXSP-CG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other