BEUDAMED
    FDA Adverse Event Other Summary report: N

    CHAIRMAN 2K

    MDR report key: 502774 · Received December 23, 2003

    Report

    Report Number
    1221084-2003-00005
    Event Type
    Other
    Date Received
    December 23, 2003
    Date of Event
    December 3, 2003
    Report Date
    December 19, 2003
    Manufacturer
    PERMOBIL AB
    Product Code
    ITI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PORTION OF THE WHEELCHAIR'S SEATING FRAME BROKE, CAUSING USER TO WEIGHT SHIFT ON THE WHEELCHAIR BASE. THIS FURTHER CAUSED THE WHEELCHAIR BASE TO DRIVE ERRATICALLY, AS THE USER WAS HEADING DOWN AN INCLINE. CHAIR THEN TIPPED OVER ONTO ITS LEFT SIDE, RESULTING IN USER RECEIVING ABRASIONS AND CAUSING DAMAGE TO WHEELCHAIR BASE AND SEATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHAIRMAN 2K POWERED WHEELCHAIR ITI PERMOBIL AB 1280 1100446

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other