BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3051777 · Received April 10, 2013

    Report

    Report Number
    3004493922-2013-00791
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Report Date
    March 13, 2013
    Manufacturer
    INVACARE SUZHOU
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    THE DEALER REPORTED THAT CHAIR WAS GIVING AN ERROR MESSAGE THAT THE CONTROLLER WAS NOT CONNECTED TO THE CHAIR. THIS ISSUE COULD CAUSE THE CHAIR TO TURN OFF INTERMITTENTLY AND CAUSE THE USER TO BECOME STRANDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152962 POWERED WHEELCHAIR 890.3860 ITI INVACARE SUZHOU M51

    Patients

    Seq Age Sex Outcome Treatment
    1 Other