BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2914735 · Received January 14, 2013

    Report

    Report Number
    1525712-2013-00374
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Report Date
    January 14, 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

    Additional Manufacturer Narrative · 1

    MDR DECISION DATE: (B)(4). NO RMA HAS BEEN INITIATED FOR THIS ISSUE. THE MALFUNCTION HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 1

    MDR DECISION DATE: (B)(6). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. DEALER STATES LOST MEMORY IN JOYSTICK DUE TO THE JOYSTICK CORD BEING PULLED LOOSE FROM THE CASE. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20968 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET TDX5-PS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other