BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2991843 · Received March 6, 2013

    Report

    Report Number
    3004493922-2013-00535
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Report Date
    February 8, 2013
    Manufacturer
    INVACARE SUZHOU
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    (B)(4). THE DEALER REPORTED THAT THE M41SRB CUSTOM POWER WHEELCHAIR UPON DRIVING FULL FORWARD AND STOPPING, THE UNIT WOULD JERK SIDEWAYS. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96303 POWERED WHEELCHAIR 890.3860 ITI INVACARE SUZHOU M41SRB

    Patients

    Seq Age Sex Outcome Treatment
    1 Other