BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 4242300 · Received November 11, 2014

    Report

    Report Number
    1525712-2014-07786
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Report Date
    October 22, 2014
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER STATES THE PART OF THE CHAIR WHERE THE TILT ACTUATOR ATTACHES HAS A WELD BREAK AND THAT FRAME PART IS NON SELLABLE PART THE CHAIR MUST BE SENT IN FOR REPAIR. CHAIR SHIPPED (B)(6) 2011 AND HAS 3 YEAR WARRANTY ON THE WELD BREAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726600 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET TDXSP-MCG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other