BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 4222862 · Received November 4, 2014

    Report

    Report Number
    3008262382-2014-01832
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Report Date
    October 16, 2014
    Manufacturer
    INVACARE REHABILITATION EQUIP
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER STATES, UNIT IS DISPLAYING AN 811 CODE AND BELIEVES THIS IS THE CONTROLLER THAT IS CAUSING IT. HE STATES THE CUSTOMER DRIVES 1.2 MILES TO (B)(6) AND IT STOPS MID-TRIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706822 POWERED WHEELCHAIR 890.3860 ITI INVACARE REHABILITATION EQUIP M41SRR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other