BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2843088 · Received November 21, 2012

    Report

    Report Number
    1525712-2012-02240
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Report Date
    November 17, 2012
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). HAS BEEN INITIATED FOR THIS ISSUE. ATTEMPTS HAVE BEEN MADE IN ORDER TO OBTAIN ADDITIONAL INFORMATION, HOWEVER TO DATE, NO FURTHER INFORMATION HAS BEEN PROVIDED. THE CONSUMER'S AGE, HEIGHT AND WEIGHT ARE UNKNOWN. THE CONSUMER'S MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN. THE CONSUMER'S TECHNIQUE WHILE USING THE DEVICE IS UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN. THE MALFUNCTION HAS NOT BEEN CONFIRMED. PARTS WERE SENT FOR REPLACEMENT AND REPAIR. THE PART/JOYSTICK MAY BE RETURNED FOR EVALUATION. IF ANY FURTHER INFORMATION IS RECEIVED ON THIS INCIDENT, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    A (B)(6) DEALER HAS REPORTED THE POWERED WHEELCHAIR STOPS AFTER 5 OR 10 MINUTES. REPORTEDLY THE CLIENT TURNS IT OFF AND RESTARTS LATER AND IS AN INTERMITTENT PROBLEM. NO INJURY. A SAMPLE IS AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET UNKNOWN POWERED WHEECHAIR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other