BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3965076 · Received July 29, 2014

    Report

    Report Number
    1525712-2014-04087
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Report Date
    June 23, 2014
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A PATIENT PROVIDER THAT AS THE PATIENT WAS DRIVING, SHE HIT A BUMP AND WAS THROWN FROM THE CHAIR. IN ADDITION, IT WAS REPORTED THAT THE MOTOR AND GEARBOX ARE COMING APART FROM ONE ANOTHER. IT IS UNCERTAIN IF THE SEPARATION OCCURRED PRIOR TO OR AFTER HITTING THE BUMP. THERE WERE NO REPORTS OF ADVERSE EVENTS, NOR ANY MEDICAL INTERVENTIONS REQUIRED. NO ADDITIONAL INFORMATION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441316 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET TDXSP

    Patients

    Seq Age Sex Outcome Treatment
    1 Other