BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2940007 · Received February 1, 2013

    Report

    Report Number
    1525712-2013-00703
    Event Type
    Malfunction
    Date Received
    February 1, 2013
    Report Date
    January 30, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    MDR DECISION DATE: (B)(6). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. PER DEALER, THE JOYSTICK IS SURGING AND HAS LOW POWER. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44260 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET FDX

    Patients

    Seq Age Sex Outcome Treatment
    1 Other