BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2940010 · Received February 1, 2013

    Report

    Report Number
    1525712-2013-00706
    Event Type
    Malfunction
    Date Received
    February 1, 2013
    Report Date
    January 31, 2013
    Manufacturer
    UNKNOWN
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    A REPORT HAS BEEN RECEIVED REGARDING AN INCIDENT THAT OCCURRED IN (B)(6). THE DEALER STATES THE GEARBOX HAS A MOTOR BRAKE FAILURE. NO INJURY. A NEW MOTOR WILL BE SENT FOR REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44261 POWERED WHEELCHAIR 890.3860 ITI UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other