BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3140933 · Received June 3, 2013

    Report

    Report Number
    1525712-2013-04273
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Report Date
    May 6, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    POTENTIAL FOR INJURY ASSOCIATED WITH A TDXSP-MCG POWER CHAIR EXPERIENCING AN UNINTENDED SHUT DOWN. THIS EVENT CAUSES THE POTENTIAL FOR THE USER TO BECOME STRANDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244091 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET TDXSP-MCG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other