BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3212075 · Received July 8, 2013

    Report

    Report Number
    1525712-2013-05481
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Report Date
    June 17, 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 PROVIDER STATED THE END USER TOLD HIM THE CHAIR SQUEALED AND THE STOPPED. THE DEALER AND END USER ARE UNAWARE IF THERE WAS AN ERROR CODE ON THE SCREEN WHEN THE INCIDENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309061 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET TDXSR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other