BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3033968 · Received April 3, 2013

    Report

    Report Number
    3004493922-2013-00715
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Report Date
    March 7, 2013
    Manufacturer
    INVACARE SUZHOU
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    (B)(4). THE DEALER REPORTED THAT THE M41SR20B POWER WHEELCHAIR BASE FRAME HAD THE SEAT POST HOLE WALLOWED, AND THE BOLTS WERE NOT SECURING IT PROPERLY. THERE WAS NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136289 POWERED WHEELCHAIR 890.3860 ITI INVACARE SUZHOU M41SR20B

    Patients

    Seq Age Sex Outcome Treatment
    1 Other