BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2921174 · Received January 17, 2013

    Report

    Report Number
    1525712-2013-00442
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Report Date
    January 17, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    INITIAL REPORT IDENTIFIED THAT AFTER 3 HOURS OF USE THE POWERED WHEELCHAIR WAS LOW ON CHARGE. NEW INFORMATION HAS SINCE BEEN RECEIVED. IN A REVIEW OF THE NEW INFORMATION IT WAS LEARNED THIS PRODUCT WAS NOTED TO VEER AND WAS BREAKING ON THE RIGHT FIRST. MDR FILED. NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26196 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET TDXSP-CG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other