BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3914159 · Received July 3, 2014

    Report

    Report Number
    3008262382-2014-00203
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    May 20, 2014
    Report Date
    June 3, 2014
    Manufacturer
    INVACARE REHABILITATION EQUIP
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    THE TBM STATES THAT ROBIN TOMER TOLD HIM THAT THE CHAIR WAS SPINNING OUT OF CONTROL ABOUT 2 WEEKS AGO. HE HAS NO OTHER INFORMATION. THE CUSTOMER IS IN A FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391904 POWERED WHEELCHAIR 890.3860 ITI INVACARE REHABILITATION EQUIP M51PSEMIRED

    Patients

    Seq Age Sex Outcome Treatment
    1 Other