BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEV 2000 - OVERLANDER POWER WHEELCHAIR

    MDR report key: 1146995 · Received August 28, 2008

    Report

    Report Number
    1931307-2008-00001
    Event Type
    Malfunction
    Date Received
    August 28, 2008
    Date of Event
    June 1, 2008
    Report Date
    August 28, 2008
    Manufacturer
    RAYES, INC. DBA WHEELCHAIRS OF KANSAS
    Product Code
    ITI
    PMA / PMN Number
    K983497
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DEALER CALLED TO ORDER PARTS AND INDICATED THAT THE END USER HAD RUN THE POWERCHAIR OFF OF A WHEELCHAIR RAMP. THIS RESULTED IN ABRASIONS TO THE LEGS AND A FRACTURED HIP. THE END USER INDICATED THAT THE CHAIR "ACTED ON ITS OWN".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PEV 2000 - OVERLANDER POWER WHEELCHAIR PEV - OVERLANDER ITI RAYES, INC. DBA WHEELCHAIRS OF KANSAS PEV

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization