BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3955480 · Received July 24, 2014

    Report

    Report Number
    1525712-2014-03982
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Report Date
    June 19, 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

    THE PROVIDER STATES DURING A ROUTINE MAINTENANCE, HEDISCOVERED OIL ON THE DRIVE TIRE BY THE AXEL ON THE LEFT SIDE.NO INJURIES NOTED (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433484 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET R51LXP

    Patients

    Seq Age Sex Outcome Treatment
    1 Other