BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3092897 · Received May 3, 2013

    Report

    Report Number
    3004493922-2013-00992
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Report Date
    April 9, 2013
    Manufacturer
    INVACARE SUZHOU
    Product Code
    IOR
    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

    PROVIDER STATES THE SEAT IS PLACED IN THE TOP POSITION ON THE SEAT POST AND THE SEAT IS VERY WOBBLY, UNSTABLE. AFTER LOOKING AT IT, IT LOOKS LIKE THE PROVIDER PLACED A SPOT WELD ON THE SEAT POST IN THE PAST IN HOPES TO ADD EXTRA SUPPORT. THERE IS ALSO A HEX HEAD BOLT MOUNTED THROUGH THE SEAT POST WHICH IS NOT THE THREADED BOLT THAT IS SUPPOSED TO BE ON THIS CHAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194568 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVACARE SUZHOU M41SR20R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other