BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 4092942 · Received September 16, 2014

    Report

    Report Number
    3008262382-2014-01081
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    February 3, 2014
    Report Date
    August 26, 2014
    Manufacturer
    INVACARE REHABILITATION EQUIP
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ENDUSER ADVISED SHAFT UNDER THE CHAIR IS CAUSING A ROCKING MOTION AND CHAIR TO LEAN FORWARD, NO INJURY, ENDUSER COULD NOT PROVIDE ANY FURTHER INFORMATION...(B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573671 POWERED WHEELCHAIR 890.3860 ITI INVACARE REHABILITATION EQUIP M41BB

    Patients

    Seq Age Sex Outcome Treatment
    1 Other