BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REDMAN CHIEF POWER CHAIR

    MDR report key: 1870668 · Received October 7, 2010

    Report

    Report Number
    MW5017721
    Event Type
    Injury
    Date Received
    October 7, 2010
    Report Date
    October 7, 2010
    Manufacturer
    CHIEF POWER CHAIR, LLC & MEDICHAIR, LLC
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REDMAN POWER CHAIR HAS CHANGED THEIR PRODUCT WITHOUT GETTING FDA APPROVAL FOR THE CHANGES. THE CHAIR NOW GOES 9 MPH INSTEAD OF THE 6 MPH APPROVED BY FDA. THEY ALSO ARE MODIFYING CHAIRS AT THEIR MEDICHAIR, LLC LOCATION. A 3 SWITCH IS ADDED WHICH BYPASSES, THE COMPUTER AND IS VERY DANGEROUS. THEY DO NOT RESPOND TO COMPLAINTS, AND THERE IS NO RECORD KEPT OF COMPLAINTS AND SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REDMAN CHIEF POWER CHAIR STAND UP POWER WHEEL CHAIR ITI CHIEF POWER CHAIR, LLC & MEDICHAIR, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening