BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 4213024 · Received October 30, 2014

    Report

    Report Number
    3008262382-2014-01772
    Event Type
    Malfunction
    Date Received
    October 30, 2014
    Report Date
    October 10, 2014
    Manufacturer
    INVACARE REHABILITATION EQUIP
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED BY A PROVIDER THAT AFTER 1 HOUR OF DRIVING A BURNING SMELL CAME FROM AN (B)(4) POWER CHAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695077 POWERED WHEELCHAIR 890.3860 ITI INVACARE REHABILITATION EQUIP M41SR20B

    Patients

    Seq Age Sex Outcome Treatment
    1 Other