BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3123151 · Received May 21, 2013

    Report

    Report Number
    1525712-2013-03995
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Report Date
    April 25, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER REPORTED THAT THE POWER CHAIR HAD A BENT FORK. THIS ISSUE COULD CAUSE THE CHAIR TO BE UNSTABLE AND THE USER COULD TIP OVER IN THE CHAIR AND BE INJURED. THE USER REPORTED THAT THEY DRIVE THE CHAIR IN THE STREET WHICH IS AGAINST THE LABELING IN TE USER'S MANUAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225050 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET TDXSR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other