BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3943217 · Received July 18, 2014

    Report

    Report Number
    3008262382-2014-00321
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Report Date
    June 11, 2014
    Manufacturer
    INVACARE REHABILITATION EQUIP
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    THE PROVIDER STATED THAT THIS WAS AN OUT-OF-BOX FAILURE. THE CHAIR WOULD TURN ITSELF BACK ON AFTER THEY POWERED IT DOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421686 POWERED WHEELCHAIR 890.3860 ITI INVACARE REHABILITATION EQUIP M51PSEMIBLUE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other