BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 4213125 · Received October 30, 2014

    Report

    Report Number
    1525712-2014-07423
    Event Type
    Malfunction
    Date Received
    October 30, 2014
    Report Date
    October 9, 2014
    Manufacturer
    UNKNOWN
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE WHEELS FOR THE TDX3 POWER CHAIR ARE NOT LEVEL HE STATED DUE TO WHAT THE DEALER BELIEVES IS AN ISSUE WITH THE STABILITY LOCK RACKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697153 POWERED WHEELCHAIR 890.3860 ITI UNKNOWN TDX3

    Patients

    Seq Age Sex Outcome Treatment
    1 Other