BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3071911 · Received April 22, 2013

    Report

    Report Number
    3004493922-2013-00874
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Report Date
    March 27, 2013
    Manufacturer
    INVACARE SUZHOU
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PROVIDER STATES SEAT POST BROKE WELDS IN BASE AND POST IS LEANING AND CUSTOMER FELL OUT OF SEAT. THIS IS ALREADY A REPLACEMENT CHAIR FOR THE SAME REASON. ORIGINAL CHAIR WAS 10JSZ180174 SOLD ON (B)(6) 2011 TO USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172838 POWERED WHEELCHAIR 890.3860 ITI INVACARE SUZHOU M41SRB

    Patients

    Seq Age Sex Outcome Treatment
    1 Other