BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 4131181 · Received October 1, 2014

    Report

    Report Number
    3008262382-2014-01370
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 23, 2014
    Manufacturer
    INVACARE REHABILITATION EQUIP
    Product Code
    ITI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER STATED THAT THE RIGHT MOTOR ON A (B)(4) POWER CHAIR IS LOCKING UP. WHEN THE CHAIR LOCKED UP IT ALLEGEDLY THREW THE END USER OUT OF THE CHAIR. USER SUSTAINED SOME SCRAPES ON HIS FACE, KNEES, AND POSSIBLY ELBOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612707 POWERED WHEELCHAIR 890.3860 ITI INVACARE REHABILITATION EQUIP M51PSR20B

    Patients

    Seq Age Sex Outcome Treatment
    1 83 Other