BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2912021 · Received January 11, 2013

    Report

    Report Number
    1525712-2013-00285
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    December 10, 2012
    Report Date
    January 11, 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

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    (B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. DEALER STATES USER WAS DRIVING CHAIR DOWN HIS DRIVEWAY (CONCRETE) AND THE CHAIR STARTED SHIMMYING AND THE REAR PIVOT ASSEMBLY CAME OFF THE LEFT REAR SIDE. DEALER STATES THIS WAS MOST LIKELY USER ERROR OR SOMETHING USER DID. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17732 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET TDXSIV-HD

    Patients

    Seq Age Sex Outcome Treatment
    1 Other