BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2864083 · Received December 10, 2012

    Report

    Report Number
    1525712-2012-02796
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Report Date
    December 7, 2012
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED BY THE CONSUMER THAT THE M61 POWER WHEELCHAIR WOULD NOT START UNLESS THE WIRES WERE WIGGLED. ADDITIONALLY, ONE OF THE WHEELS GOT, STUCK AND WOULD NOT SWIVEL. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET M61

    Patients

    Seq Age Sex Outcome Treatment
    1 Other